October 2014 by McMahon Group

CONVENTION ISSUE:

American College of Surgeons Clinical Congress

GENERALSURGERYNEWS.COM

October 2014 • Volume 41 • Number 10

The Independent Monthly Newspaper for the General Surgeon

Opinion

The Surgical Robot for Hernias: Converts and Holdouts

In the Dark B Y L AUREN K OSINKSI , MD

B Y C HRISTINA F RANGOU

he detailed plan that was rolled out at my hospital for responding to the surgeon who refuses to conduct the prescribed time-out at the start of each operation included a script for the nursing staff to address the surgeon, the leadership contact for emergency intercession, and instructions for the anesthesiologist to abort induction and for the surgical tech to roll the back table several feet from the operating room (OR) table. The final intervention to prevent the errant surgeon from seizing a tool and commencing the operation was to turn off the lights in the room—all of them.

Why surgeons must not disengage from the difficult discussions. I actually felt ill when I read this memo and tried to absorb how deeply broken relations in the OR must be, or are perceived to be, to inspire this directive. It was difficult to imagine an OR scenario in which it would be necessary to execute every step of the directive. As I inventoried my behavior as an attending surgeon—which I generally regard as somewhat flawed—to try to understand what would inspire this plan, I also reflected on the complex psychosocial agendas of all the staff in the room and the difficulty of making each person see IN THE DARK page 44

wo years ago, in a General Surgery Newss interview w about the surgical robot’s role in n hernia repair, laparoscopic surgeeon Karl LeBlanc, MD, answered unequivocally: “Inappropriate.” Today, despite no new evidence to the contrary, he has changed his mind. “I’ve had d to eat my words on that particcular topic,” he said. Dr. LeBlanc, a hernia su urgeon at the Surgeons Group of Batoon Rouge, in Louisiana, and clinicaal professor of surgery at the Louisiana State University School of Medicine, New Orleans, said he began to reconsider his opposition to the rob bot earlier this year after anecdotal reeports that patients experienced less ch hronic pain

B Y M ICHAEL V LESSIDES

see HERNIA ROBOT page 38

101 Tips for a Chief Surgical Resident B Y D EVIN F LAHERTY , DO, P H D ver the past five years, I have had the privilege of training under Marc A. Neff, MD. He not only taught me invaluable surgical skills in the operating room (OR), but also challenged me and my peers to perform continued self-evaluation. In 2013, at the beginning of my chief

INSIDE In the News

Opinion

Surgeons‘ Lounge

After More Than a Century, Debate on Hernia Repair Methods Is Stronger Than Ever

But Overall Opioid Use U changed in Lap Chole Study Un

The Politically Correct Operative

Report By Leo A. Gordon, MD

Your Reponses Requested! A case of a patient with a painful enlarging symptomatic umbilical hernia

Nausea, Vomiting Reduced With IV A Acetaminophen

year of surgical residency, I presented all residents in my program with Dr. Neff ’s “101 Tips for Surgical Internship,” published in General Surgery Newss in August 2012. Near the completion of my residency, Dr. Neff challenged me, one last time, to create my own list of see CHIEF RESIDENT page 41

MONTTREAL—Preliminary data indicate reducced postoperative/post-discharge naauseea and vomiting (PONV/PDNV) an nd improved patient satisfaction after a singgle dose of IV acetaminophen in paatien nts undergoing laparoscopic choleccysttectomy, compared with traditional op pioid-based anesthetics. Despite th his, the overall amount of opioid ad dmin nistered intraoperatively and in th he p postanesthesia care unit (PACU) waas n not reduced. “There have been a lot of reports, booth anecdotally and in the literature, ab boutt ways to help minimize PONV an nd p pain,” commented Daniel Bosshart, M assistant professor of anesthesiolMD, ogy at og a Hofstra North Shore–LIJ School of Medicine, in Hempstead, New York. “So, w “So we wanted to determine the effect of a single dose of IV acetaminophen on PONV, PDNV, pain and overall patient satisfaction.” Dr. Bosshart and his colleagues see LAP CHOLE page 12

REPORT Considerations in Selecting Mesh For Hernia Repair: Evaluating the Role of a Hybrid Hernia Device See insert at page 24

Thin is in. The uncommonly slender chassis and front bezel first catch your attention. Then you notice the exceptional brightness of the display. Corner-to-corner uniformity is superb. You see how the robust OptiContrast Panel™ protects the screen while reducing glare and reflection. Finally you realize Sony’s 27-inch* screen provides a larger viewing area and fits onto the same carts and boom arms that currently take 26-inch models. Design meets technology. And you meet a brand new standard in visualization for today’s OR. Arrange a demo at sony.com/lmd27. © 2014 Sony Electronics Inc. All rights reserved. Reproduction in whole or in part without written permission is prohibited. Features and specifications are subject to change without notice. Sony and OptiContrast Panel are trademarks of Sony. * Viewable area, measured diagonally. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional. CAUTION: See product labeling for indications, contraindications, warnings, cautions, and directions for use.

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

My Wish for a Better Imaging Report Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

everal years ago, the College of American Pathologists (CAP), joined by the American Joint Committee on Cancer (AJCC), created an entirely new concept in the reporting of a surgical pathology document—the synoptic pathology report. Since the days of Virchow, pathology reports had been composed using the format of a PhD thesis and required the reader (i.e., interpreter) to decipher a cornucopia of descriptions in order to discern the ultimate anatomic and histologic answers resulting from a surgical procedure for cancer. What tissue was removed and how much; what type of histology was found; were lymph nodes removed and if examined, were these free of tumor? Classically, the extent (or stage) of the tumor was not discussed. The surgeon was left with the daunting task of reading the entire document

(usually more than once!) and then relay- to remain solely in the bailiwick of the ing the information to other members pathologist. What if a radiology report, of the management team as well as the especially one relating to the clinical patient and his or her caregivers. stage of a cancer patient, could be codYes, many reading this column remem- ified, and contain all the elements so ber the “bad old days” of pathology important for treatment planning? What reports. Things have certainly improved if the ambiguous terms so frequentas the concept of “synly encountered in a CT optic reporting” of surgi- What if the ambiguous [computed tomography] cal pathology results has terms so frequently or MRI [magnetic resbeen streamlined and onance imaging] report codified to give a clear encountered in a CT could be better defined and precise, line-by-line or MRI report could and codified? Yes, this description of the major would be the next big elements of an extirpated be better defined and leap in bringing clarity solid tumor. This stanto clinical reporting and codified? dard approach, culmiwould serve to improve nating with the known communication among pathologic elements of the TNM sys- the diagnostic radiologist, nuclear medtem is now a benchmark of quality in the icine specialist, angiographer and the more than 1,500 Commission on Can- surgeon. cer–accredited hospitals in the United Although still in its infancy, synoptic States. As new factors are appreciated in radiologic reporting has gained traction the outcomes of cancer, these are added in some circles. The Cancer Care Ontario to the elements that currently are report- group working in Canada has developed ed and are frequently updated by CAP. a synoptic template for the reporting of I have often felt that this system of rectal cancer involvement using MRI synoptic reporting is too revolutionary (Cancer Care Ontario, Optimization

of Preoperative Assessment in Patients Diagnosed with Rectal Cancer, 2014; Appendix 2; www.cancercare.on.ca/cms). I would urge my colleagues interested in rectal cancer to look at this template and to introduce it to their diagnostic radiologist as an excellent example of the synoptic approach. Who knows, it may even create a spark and lead to standardized reporting for CT and PET [positron emission tomography] scan results! My recommendation is to create a working group at your own facility consisting of radiologists, radiation oncologists, surgeons and others to create a synoptic template for a few tumors (rectum, lung, head and neck, pancreas) to clarify, quantify and simplify radiology reports dealing with these entities. This would be a great start to a snowball effect that could have positive ramifications nationally and internationally. Who knows, it may even encourage organizations and societies dedicated to imaging to take the same bold leadership role as CAP and AJCC have displayed in the creation of the synoptic surgical pathology report. Wouldn’t that be great!

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Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN

Kay Ball, RN, CNOR, FAAN Lewis Center, OH

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L.D. Britt, MD, MPH Norfolk, VA

David Earle, MD Springfield, MA

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Lauren A. Kosinski, MD Milwaukee, WI

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

A Century Later, Debate on Hernia Repair Is Stronger Than Ever B Y V ICTORIA S TERN

uring a panel discussion on laparoscopic inguinal hernia repair fixation at the 2014 annual meeting of the American Hernia Society, Robert Bendavid, MD, FACS, FRCS(C), a surgeon at the Shouldice Hospital in Toronto, Ontario, Canada, raised concerns about the use of mesh in hernia repair. He called attention to the harm that mesh can do when it’s used ubiquitously, citing thousands of patients who have experienced devastating mesh-related complications after inguinal hernia repair and pelvic organ prolapse (POP), including erosion, infection, fistulas and chronic pain. “Although mesh is a necessity in certain surgeries, like incisional hernia repairs, there is very little need to ever place mesh in the groin or pelvis,” Dr. Bendavid told General Surgery News. “The trend today is to put mesh in all patients, especially women, but in the last 30 years we have not seen a reduction in the rate of recurrence with the advent of mesh or laparoscopic surgery.” Guy Voeller, MD, FACS, the chair of the panel, defended the use of mesh. “Mesh has helped many people,” Dr. Voeller, professor of surgery at the University of Tennessee Health Science Center (UTHSC), in Memphis, told GSN. N “There is no question that mesh has lowered the recurrence rate in inguinal, as well as incisional and ventral, hernia repairs. And it’s not as if surgeons are pushing mesh on patients without evidence, there have been studies showing its benefits.” Despite his stance, Dr. Voeller cautioned that mesh can cause significant issues in certain patients. “We have three sensory nerves in the groin, and in a minority of patients—about 4% to 6%—mesh may lead to chronic, debilitating pain when placed in the groin,” he said. “Thus, we should shy away from employing a shotgun approach of putting mesh in everyone when sometimes an autogenous repair would work just as well or better.” This controversy in hernia repair—is mesh good or bad, and what mesh is best—is not new. Surgeons have debated the topic for decades, but the sides have become more polarized during the past few years. Both the American and European hernia societies advocate the use of mesh in inguinal hernia repair, while the number of surgeons, such as Dr. Bendavid, who predominantly perform suture-only, is waning. But alongside this movement away from autogenous repair, mesh appears to be getting a bad name in the public eye. Thousands of patients have sued companies over meshrelated complications after POP and hernia repair, leading to concerns that mesh is being used too frequently and at times, inappropriately. Considering the vast array of hernia repair techniques and mesh options, resolving the controversy may be difficult. For technique, open primary suture hernia repair boasts the Shouldice and Bassini repairs; open mesh procedures offer the Lichtenstein, Kugel, prolene hernia system or plug-and-patch; and laparoscopic hernia repair includes totally extraperitoneal, transabdominal preperitoneal or intraperitoneal onlay patch approaches (see “Laparoscopic Techniques for Hernia Repair: A History of Ups and Downs,” GSN N March 2014, page 1). The mesh options also continue to expand. After choosing the type of material—possibly a synthetic such as polypropylene, polyester or expanded polytetrafluoroethylene (ePTFE), a biologic or a composite

mesh—surgeons must deal with variations in each cat- Fla. “A solution that works perfectly for one patient egory, such as weight, absorbability, pore size, filament may cause complications in another patient. To move structure, mesh configuration, durability, and weave or forward, we need to accept that there is no one right net, all of which may or may not affect outcomes. answer when it comes to hernia repair, or health care Adding to the complexity, when evaluated in ran- in general.” domized controlled trials (RCTs), the data are often inconsistent. For years, the Shouldice Hospital has The Rise of Mesh reported recurrence rates for autogenous inguinal herTo understand how this debate emerged, it is impornia repairs of less than 1% (Can J Surgg 1997;40:199- tant to trace the history of both hernia repair and mesh. 205). Several decades ago, some surgeons were able In the latter half of the 1880s, Edoardo Bassini, MD, to replicate these results ((J Chir [Paris]] 1993;130:275- commonly referred to as the father of modern-day hernia 277), but that is not the case today, with institutions surgery, introduced the three-layer autogenous inguinal reporting recurrence rates between 6% and 50% (Br J hernia repair. Before this, the failure rate for inguinal Surgg 2005;92:1085-1091). hernia repair was essentially 100%, but using his new “Hernia repair is perhaps the technique, Dr. Bassini reduced the most controversial topic in sur- ‘Blanket statements about failure rate to less than 4% (8 in 206 gery,” said Robert Sewell, MD, hernia repairs) over three years. when to use, and not to a general surgeon at the Master With the success of the Bassini Center for Minimally Invasive use, mesh will not provide repair, notable surgeons, including Surgery, in Southlake, Texas. “We William Halsted, Chester McVay answers for all patients.’ and E.E. Shouldice, modified the have so many different techniques and types of mesh, and people are technique, although none proved —Michael Rosen, MD bouncing back and forth to find to be as successful as Dr. Shouldi‘the one.’” ce’s. The Shouldice repair was almost identical to the The problem may be that this quest to find the best Bassini repair, with perhaps the most notable differencmesh or technique may be missing the point. es being the use of continuous instead of interrupted “We so desperately want to find out which mesh sutures and of a second line of repair. is good or bad, right or wrong, but it’s impossible to In 1945, Dr. Shouldice established a hospital in reduce hernia repair to these black-and-white terms Toronto centered on his technique, and after almost 70 because we’re dealing with complex systems,” said Bruce years of close patient follow-up, the Shouldice Hospital Ramshaw, MD, FACS, chairman of the Halifax Health continues to boast a recurrence rate of less than 1% for general surgery residency program and co-director of inguinal hernia repair. Advanced Hernia Solutions (AHS), Daytona Beach, Although mesh has become mainstream only in the past 20 years, its history extends back over a century. In 1900, surgeons started using mesh composed of silver, Table. Examples of Mesh and Grafts but the malleable metal left patients with an increased By Category† risk for infection and fistulas. Several other mesh iterations, including toilinox (made of stainless steel) and Synthetic nylon, entered the picture, but were abandoned after Vicryl (Ethicon) polyglactin surgeons deemed the rate of mesh-related complicaAbsorbable, medium weight, small pore tions too high. Dexon (Syneture) polyglycolic Surgeons eventually began using synthetic mesh Absorbable, medium weight, medium pore made of plastic. In 1944, French surgeon Don Aquaviva, MD, performed the first hernia repair using a simMarlex (Davol), Prolene (Ethicon), Prolite (Atrium ple onlay technique, in which he carpeted the posterior Medical), Atrium (Atrium), Trelex Natural (Meadox) wall with mesh while leaving the defect intact. More polypropylene than 15 years later, Francis Usher, MD, used polyproNonabsorbable, heavy weight, small to medium pylene mesh for difficult inguinal and incisional herpore nia cases. By the late 1960s, American surgeon Richard Mersilene (Ethicon) polyester Newman, MD, had completed more than 1,600 herNonabsorbable, medium weight, large pore nia repairs with Marlex mesh, originally composed of high-density polyethylene when conceived in 1958 but Composite changed to polypropylene in 1962. Dr. Newman had Vypro, Vypro II (Ethicon) polypropylene modified Dr. Usher’s tension-free technique by elimiPartially absorbable, light weight, large pore nating the need to open the posterior wall, duplicating Gortex Dual Mesh ePTFE what Dr. Aquaviva had done in 1944. Nonabsorbable, heavy weight, very small pore Despite Dr. Newman’s success, surgeons continued to view mesh with intense skepticism. Because no Parietex Composite (Covidien) polyester/collagen one would publish his data, Dr. Newman called on his Partially absorbable, medium weight, large pore esteemed colleague, Irv Lichtenstein, MD, for help. Biologic “Ultimately, Dr. Lichtenstein ended up pushing mesh to the forefront, which consequently overshadowed Dr. Surgisis (Cook) porcine small intestine submucosa Newman’s important efforts,” Dr. Voeller said. AlloDerm (LifeCell) human acellular dermis Every year at the meeting of the American College CollaMend (Davol) xenogenic acellular dermis of Surgeons, Dr. Lichtenstein promoted this new repair (porcine/bovine) in a poster session, and Davol, the hernia division of the company Bard, began to make mesh for him, and † Not an exhaustive list of hernia mesh products.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

he soon started publishing data on the technique. In a 1987 publication, Dr. Lichtenstein reported a recurrence rate of 0.7% among 6,321 herniorrhaphies over a two- to 14-year follow-up (Am ( J Surgg 1987;153:553-559). Despite Dr. Lichtenstein’s efforts, many surgeons remained unconvinced of mesh’s potential for decades. “Back when I trained in the 1970s, we were taught never to use mesh,” Dr. Sewell recalled. Although adoption was slow, mesh eventually gained worldwide notoriety. In 1985, Arthur Gilbert, MD, recalled asking a crowd of surgeons at a hernia meeting, how many of them used mesh. “Less than 5% of the crowd raised their hands,” said Dr. Gilbert, associate clinical professor of surgery at the University of Miami Miller Medical School, and director and founder of the Hernia Institute of Florida. But four years later, when he asked the same question to a room full of hernia surgeons, that figure had jumped to 40%. In the 1990s, with the advent of laparoscopic hernia repair, mesh gained new prominence. “You couldn’t repair a hernia laparoscopically without mesh,” Dr. Sewell said. “Laparoscopic surgery lessened the concern over mesh infection compared with open.” As the demand for mesh increased, so did the variations. “Once people figured out you could make a plastic mesh, engineers started overdesigning it,” said Michael Hiles, PhD, vice president of research and clinical affairs at Cook Biotech, in Indianapolis. Companies initially made mesh heavier and thicker, but surgeons soon realized that the overworked synthetic mesh was too dense and increased the risk for inflammation and infection. To avoid these problems, industry branched out in different directions, giving rise to a host of new synthetic mesh designs, as well as biologic and composite options (Table). Fast forward to the present day: Mesh essentially dominates hernia repair, and suture-only hernia repairs have been phased out of surgical training. “Mesh has become so dominant that we don’t train our residents to do hernia surgery without mesh, which I believe is a big problem,” Dr. Voeller said.

In Search of the Ideal Mesh Despite the available options, surgeons have yet to find the perfect mesh. When it comes to defining an ideal mesh, studies have shown that pore size, filament type, weight, tensile strength, memory and the ability to blend seamlessly with the body and reduce the chances of a foreign body reaction are important attributes (Hernia 2010;14:81-87; Ann R Coll Surg Engll 2010;92:272-278). “From a surgeon’s perspective, an ideal mesh is compliant, easy to use, inexpensive, durable and predictable,” said AHS co-director Dr. Ramshaw. “Similarly, for the patient, an ideal mesh will fix the hernia, does not hurt, cost extra or cause unanticipated consequences.” To these qualities, Dr. Bendavid added, “The mesh should be easy to remove in case of complications, a most important attribute that has become especially so with mesh complications.” As with most things in medicine, mesh can come with complications. With synthetic mesh, there are documented problems with erosion and migration through the bowel wall. Sometimes mesh causes inflammatory changes, and if the mesh wrinkles or folds, it can cause pinching and pain or become hard, Dr. Sewell noted. In a recent editorial, Josef Fischer, MD, FACS, of the Department of Surgery at Harvard Medical School, in Boston, raised concerns over the devastating effects of inguinodynia, reported in up to 21% of mesh hernia

‘A solution that works perfectly for one patient may cause complications in another patient. To move forward, we need to accept that there is no one right answer when it comes to hernia repair, or health care in general.’ —Bruce Ramshaw, MD

repairs. To avoid these complications, he proposed that surgeons abandon mesh in favor of transversalis or Shouldice Hospital repair ((Am J Surgg 2013;206:619-623). Dr. Gilbert responded in an editorial, writing that in expert hands, the incidence of recurrence and chronic pain is actually quite low (Am ( J Surgg 2014;207:10021003). He found that adding mesh to a Shouldice repair reduced his recurrence rate from 2% to 0.5%. In terms of chronic pain, he said that inguinodynia cases are more likely due to a surgeon’s lack of knowledge of groin anatomy and less than ideal technique, not the mesh itself. Edward Felix, MD, senior surgical consultant and surgeon at Marian Regional Medical Center, in Santa Maria, Calif., agreed, noting that he has documented a recurrence rate of 0.4% after laparoscopic hernia repair (Surg Endoscc 1998;12:226-231), and that the incidence of chronic pain is much lower than Dr. Fischer reports, with research showing that onlyy 4% of patients experience chronic pain after total extraperitoneal repair (Surg Endosc 2010;24:1707-1711). “If mesh were the problem that Dr. Fischer says it is, we would be seeing a high incidence of chronic pain in our patients, but after 23 years of performing mesh laparoscopic hernia repair in thousands of patients, this has not been our experience,” Dr. Felix said. Yet concerns over complications and recurrence have influenced some experts to abandon synthetic materials in favor of composite mesh or biologic materials, with the hope that grafts derived from pig dermis, human cadaver skin and porcine small intestine will integrate into the body more easily than plastic, and eliminate these complications. “For about five years, everyone jumped on the biologic

mesh bandwagon,” Dr. Felix said. It soon became clear, however, that biologic mesh had its own problems, namely that it only provided a temporary fix. When using a biologic material composed of dermis, the graft will eventually fail, said Dr. Hiles, of Cook Biotech. Given the elasticity of skin, the mesh will stretch and cause a hernia to form or recur. To prevent stretching, the team at Cook has been working for almost 20 years to perfect a biologic graft made from the submucosa of the small intestine, which can blend into the vascular tissue and does not stretch over time. “Over the past two years, our results show that these grafts incorporate very well and lead to fewer recurrences,” Dr. Hiles said. Even if recurrence rates can be reduced, cost remains a downside of biologics. “Biologics are very expensive and can cost over $10,000 for a little piece,” Dr. Bendavid said. “Imagine if you require several pieces or have a particularly large hernia, the price will increase quickly.” Aside from mesh, sutures and fixation devices can be problematic. “A piece of suture is still a foreign body, and tacking devices can cause issues too,” Dr. Hiles said. “Metal tacks, for instance, are pointy and may puncture something, while absorbable tacks don’t seem to hold things as well.” Additionally, when one looks beyond hernia repair to POP procedures, the rate of complications increases substantially. “Patients experience a high percentage of recurrences when surgeons have tried to sew the bladder or vagina back up, so the use of mesh for vaginal and bladder suspension has exploded,” Dr. Voeller said. “But now, we have mesh eroding into the rectum, causing all see HERNIA DEBATE page 6

In the News HERNIA DEBATE jcontinued from page 5

these problems and lawsuits we’re hearing about.” Dan Bolton, JD, a lawyer at Keller, Fishback & Jackson LLP, in Los Angeles, who represents patients suffering from POP and hernia mesh complications, cited about 50,000 cases pending against half a dozen manufacturers over complications with POP mesh surgeries. “I’ve talked to many patients after POP procedures who describe disabling pain after polypropylene mesh has moved, eroded, contracted or cut into organs,” he said. “These issues can require multiple surgeries and thousands of dollars to fix.” Dr. Hiles believes that polypropylene mesh should never be placed on the pelvic floor. “With such a dynamic tissue, moving back and forth and up and down, you get erosion,” he said. “It’s like rubbing sandpaper on the skin. It may not hurt at first, but by the 200th time, it sure does. That is what’s been happening on the pelvic floor with polypropylene mesh.” On the other hand, even with the high rate of meshrelated complications in POP procedures, “some people are helped by mesh suspension who wouldn’t get relief in any other way we know of,” Dr. Ramshaw said. Additionally, it’s important to distinguish between hernia repair and POP procedures. “Gynecological bladder suspension is not hernia repair,” Dr. Felix said. “POP procedures are not done by general surgeons and involve different placement of mesh.” Part of the issue may be the FDA’s 510(k) approval process, which establishes equivalency but does not evaluate the safety and efficacy of a product. What this means for synthetic mesh is that if a mesh is deemed safe and effective for repairing groin hernias, by 510(k), it will likely also be deemed safe for vaginal and bladder support. “510(k), therefore, means that companies do not need to do clinical trials to make sure mesh works for these different surgeries,” Dr. Voeller pointed out. “Consequently, the FDA has been under the gun for being less than rigorous when it comes to their mesh approval policies.” Dr. Hiles doesn’t think the problem is the level of regulation of mesh, but rather that companies need to be more responsible when it comes to testing the safety of new products or those designated for new procedures. “We need to get clinical experience with different mesh used in different surgeries,” he said. “After approval, most companies do a worldwide marketing blitz without knowing the clinical effects of their mesh product. The world of hernia surgery has so many options that it’s mind-boggling, and surgeons need to be more careful about what they choose.”

When To Use Mesh Although the mesh landscape is complex and mesh can come with problems, most studies support its use in hernia repair. “Mesh is a necessity in certain surgeries, like incisional and femoral hernia repair; but when we get to the groin, mesh is necessary in probably only 1% to 3% of cases,” Dr. Bendavid said. “For femoral hernia repairs, even the Shouldice Hospital has had a high recurrence with suture-only repair. These types of surgery really do require mesh.” For incisional hernia repair, recurrence rates in sutureonly procedures vary from 12% to 54%, and those in mesh repair range from 2% to 36% (World J Surg 1997;21:62-65). A study found that after three years, 43% of patients who had undergone suture-only repair

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

to fix primary hernias had a recurrence compared with 24% of those who underwent open mesh repair. The recurrence rate for suture-only repair jumped to 58% when repairing a recurrent incisional hernia (N Engl J Medd 2000;10;343:392-398). When the Shouldice Hospital tracked femoral and incisional hernia mesh repairs from 1983 to 2002, it reported much lower recurrence rates of 1.7% and 2.5% for 647 femoral repairs and 1,385 incisional repairs, respectively, over the span of one to 15 years (Surg Clin North Am 2003;83:1163-1187). The recurrence rate improves, too, when performing ventral and incisional herniorrhaphy laparoscopically. Franklin and colleagues reported a 2.9% recurrence rate over an average of four years (Herniaa 2004;8:2327), while Drs. Ramshaw and Voeller as well as Todd Heniford, MD, and Adrian Park, MD, showed a 3.4% recurrence rate using an ePTFE mesh (J ( Am Coll Surg 2000;190:645-650). A subsequent study revealed a 4.7% recurrence rate in 819 patients undergoing laparoscopic ventral hernia repair with ePTFE mesh ((Ann Surgg 2003;238:391-4000).

‘Mesh is a necessity in certain surgeries, like incisional and femoral hernia repair; but when we get to the groin, mesh is necessary in probably only 1% to 3% of cases.’ —Robert Bendavid, MD “For ventral hernia repairs, rs, it is unequivocally proven that mesh is important,” said Michael Rosen, MD, professor of surgery and medical director, Cleveland Clinic Foundation, Comprehensive Hernia Center, in Ohio. The data on inguinal hernia repair may be less clearcut. One review comparing suture-only with open mesh repairs found that the Shouldice repair had the lowest recurrence rate among all suture-only repairs, but that open mesh techniques had lower recurrence rates than the Shouldice repair (Cochrane Database Syst Rev 2012;4:CD001543). “For inguinal hernias, there is good data on both sides of this,” Dr. Rosen said. “Mesh has been very helpful at reducing recurrence rates, and there’s good evidence to support that, but there’s a trade-off when introducing a foreign body into someone’s groin because of the potential for nerve damage. That is a downside of mesh. I don’t think the rate of those things occurs in clinically relevant numbers for hernia repair, but for those who are affected, the results are devastating.” Still the Shouldice Hospital continues to report recurrence rates of less than 1% for primary inguinal hernia repair. This success may be explained, in part, by the fact that the Shouldice Hospital performs 7,500 inguinal hernia repairs every year, and in part, due to careful patient selection, with candidates required to achieve a particular weight before undergoing surgery, Dr. Voeller said. “Dr. Bendavid always felt that repairing inguinal hernias without mesh was best, and there’s no question that is the case in Shouldice Hospital’s hands,” said Dr. Voeller, who underwent two Shouldice repairs more than a decade ago after being deemed ineligible for laparoscopic surgery because of previous procedures. “My repairs were perfect, but when other centers have tried to

replicate the 1% to 2% recurrence rate of the Shouldice Hospital, they have failed.”

Future of Mesh: Where Are We Headed? At the heart of this debate is the patient. The key to improving patient care, Dr. Ramshaw said, is to understand what a mesh is going to do in different patients when placed in different regions using different surgeries. This consideration involves a myriad of factors, such as a patient’s age, weight, diabetes, tobacco and alcohol use, prescription medication use, previous surgeries and medical conditions. “Hernia patients are getting more complex,” he explained. “Traditional research says if we control all the variables, we can find the best mesh; but in truth, we can never control all the variables no matter what we do. There are things outside of our control, and as a result, we will probably never have one ideal mesh or hernia repair.” Dr. Rosen ag agreed that there is no one right answer when it comes to hernia repair. Surgeons need to better stratiffy who will benefit from mesh and who will not, using a risk-benefit analysis to determine what’s b best for the individual patients. “Blanket statemeents about when to use, and not to use, mesh w will not provide answers for all patients.” Accoording to Dr. Ramshaw, defining what mesh is best for what groups of patients is an evolution, an nd can be accomplished by implementing a program m of care that centers on the patient. “Th he problem with relying on RCTs is they wiill give you one right answer, but in realitty, data generated from RCTs provides a very limited understanding of patient ccare in the real world,” he said. “Ratheer than debating whether laparoscopic or open surgery is better, or whether mesh or op suture-only is better, we need to understand that one size does not fit all.” Dr. Ramshaw, who is cofounder, chairman and chief medical officer of the Transformative Care Institute, is developing a novel approach to hernia repair. Using a team of diverse experts, he works to provide a full spectrum of care to the patient and the patient’s family. He believes this patient-centric approach will allow the team to understand factors that affect each individual and determine whether notable patterns emerge across patient populations. Surprisingly, Dr. Ramshaw and his team have found that the second most important factor in successful hernia repair is a patient’s emotional state, level of anxiety, and depression before and after surgery. Perhaps for some, a key part of care is focusing on assuaging any fears and anxieties. “When you look closely at the data in new ways with a diverse team, you often find things you wouldn’t expect,” he said. “Essentially, the bottom line is we need to get back to real patient care, where we form genuine relationships with the patient, and use that information to integrate new knowledge and value-based treatment options into their lives.” Drs. Bendavid, Fischer and Sewelll reported no significant financial interests or relationships. Dr. Felixx reported receiving consulting fees from Cardica. Dr. Gilbertt reported that he has been a surgical consultant for Ethicon, Inc. Dr. Ramshaw reported receiving grant, honoraria or fellowship support from B. Braun, Covidien, Ethicon, MTF, Novus, STS and W.L. Gore. Dr. Rosen reported receiving grants and/or honoraria from LifeCell, Davol and W.L. Gore. Dr. Voellerr reported receiving consulting fees from C.R. Bard and W.L. Gore.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Immune Response to Major GI Surgery, Blood Transfusions Mapped Mortality Affected; Findings Offer Possibility of Risk Stratification B Y J AMES P RUDDEN STOCKHOLMâ&#x20AC;&#x201D;Major gastrointestinal (GI) surgery promotes a specific gene expression pattern that upregulates the anti-inflammatory cytokine interleukin (IL)-10 while depressing proinflammatory immune pathways. Blood transfusions likely exacerbate this immune response, which also is associated with an increase in infectious complications. The finding raises the possibility that risk stratification for postoperative complications might use immunologic factors for prediction. Immune response to a major physiologic insult includes an early proinflammatory phase, known as the systemic inflammatory response syndrome, which is then followed by an anti-inflammatory phase, known as the compensatory anti-inflammatory response syndrome (N Engl J Medd 2003;348:138-150). Noting that the evidence supporting these two phases is scant and that more recent data have questioned its

accuracyâ&#x20AC;&#x201D;especially in patients with severe sepsis or blunt trauma (Nat Rev Immunoll 2013;13:862-874)â&#x20AC;&#x201D;a group of investigators from Barts and The London School of Medicine and Dentistry as well as Bloomsbury Institute of Intensive Care Medicine at University College, London, undertook an analysis of gene expression in patients having major GI surgery.

Patients receiving blood transfusions were more likely to develop infectious complications and pneumonia, and were more likely to die in the hospital, the researchers concluded. All patients were aged over 45 years and were examined daily for the presence of infection (Table). Packed red blood cell (PRBC) transfusions were used because, unlike the effect of whole blood transfusions on postoperative infections, the immunologic consequence of

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Table. Patient Demographics Infection No P (n=44; 37%) infection Value (n=75; 63%) Age, y

66 (range, 59-75)

64 (56-71)

0.19

Male, %

1.0

Diabetes, %

0.80

Current smokers, %

0.64

Smoking history, %

0.34

Cancer diagnosis, g % 55 Preoperative immunosuppression, % 14

71 14

0.10 1.0

Duration of operation, min Endoscopic surgery, %

243 (range, 176-313) 18

195 0.06 (142-295) 32 0.13

Planned post-op ICU admission, %

0.22

ASA grade 3 or 4, %

1.0

General

â&#x20AC;&#x201C;

Upper GI

â&#x20AC;&#x201C;

Colorectal

â&#x20AC;&#x201C;

HPB

â&#x20AC;&#x201C;

HPB + colorectal

â&#x20AC;&#x201C;

General + colorectal

0.84

Intraoperative blood transfusion

0.17

Blood transfusion in the last 24 h, % 23

0.02

In-hospital death, %

1.0

By Surgical Specialty, n

ASA, American Society of Anesthesiologists; GI, gastrointestinal; HPB, hepatopancreatobiliary

leukocyte-depleted, PRBC transfusions is not well defined. The investigators, whose principal author was Paraskevi Fragkou, MBBS, hypothesized that major GI surgery will provoke an early postoperative immunosuppressive pattern of gene expression that will increase susceptibility to infectious complications. They also surmised that the transfusions themselves might contribute to immunosuppression in these surgical patients. Blood was collected preoperatively and at 24 and 48 hours postoperatively. Messenger RNA (mRNA) was extracted and mediators descriptive of specified T-cell pathways were quantified by polymerase chain reaction. The analysis of blood transfusion and immune pathways revealed a distinctive gene expression pattern. Foxp3, IL-12, IL-23, GATA3, RORg and tumor necrosis factor (TNF)Îą/IL-10 mRNA levels were lower in those receiving

blood transfusions in the first 24 hours postoperatively. Foxp3, IL-23, RORg and TNFÎą/IL-10 mRNA levels were also lower at 48 hours postoperatively. IL-27 mRNA levels were unaffected by blood transfusion. The authors, who presented their results at Euroanaesthesia 2014 (abstracts 1AP4-2 and 6AP21), found that mortality was associated with higher IL-10 mRNA levels at 48 hours, lower levels of IL-23 mRNA at 24 and 48 hours, and lower levels of RORg mRNA at 48 hours. They concluded that patients receiving blood transfusions were more likely to develop infectious complications and pneumonia, and were more likely to die in the hospital. They found that blood transfusions during and after major GI surgery were â&#x20AC;&#x153;associated with a distinctive gene expression pattern that includes a dramatic upregulation of the anti-inflammatory cytokine IL-10.â&#x20AC;?

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Race Matters as a Factor in Pain Management, but W B Y M ICHAEL V LESSIDES

s if managing the broad spectrum of patient pain were not complex enough, results from an Indiana University-Purdue University Indianapolis study has found that patient race, provider bias and clinical ambiguity interact to influence providers’ assessment and treatment decisions. The researchers suggested that understanding these factors and their influence might be an important step toward improving patient care. “Previous research has found that providers treat black and white patients differently whenever they have chronic pain,” said Adam T. Hirsh, PhD, assistant professor of psychology at the Indianapolis institution. “We’re interested in exploring why that may be. Is it simply because the patients differ in their race? Or are there other things at work here, too?” To help tease out these possible factors, Dr. Hirsh and his colleagues studied 110 resident physicians who made pain assessment and treatment decisions for 12 computer-simulated patients. In each vignette, a patient presented with acute pain. Patient race (white or black) and clinical ambiguity (low or high) were manipulated across vignettes. The 110 participants also completed measures of implicit and explicit racial bias. “The explicit measure asks people point-blank how they feel toward European American and African American patients,” Dr. Hirsh said. “The implicit measure gets at the more subtle forms of racial bias, which seems to be more prominent in contemporary society and may have a stronger effect on clinical care. Few people will outwardly say they dislike black or white people. But when you give them the implicit association test, a majority of people in the U.S. actually show an implicit preference for white rather than black people.” As Dr. Hirsh reported in Tampa, Florida, at the 2014 annual scientific meeting of the American Pain Society (abstract 511), the sample demonstrated moderate to strong implicit bias favoring white patients over black patients, and indicated more explicit positive feelings toward whites than blacks. When analyzed separately, clinical ambiguity had a stronger influence on participants’ decisions than did patient race. However, when patient race and clinical ambiguity were examined together, an interesting picture emerged. “We found an interesting interaction,” he explained. “Race mattered, but it mattered in a way that was tied to ambiguity. In the low back pain [high-ambiguity] conditions, black patients actually received higher pain intensity ratings and were

more likely to be given an opioid, relative to whites. However, this effect reversed in the wrist fracture [low-ambiguity] situations, where white patients were given higher pain intensity ratings and more opioid medications than black patients. “So race mattered, but it mattered according to ambiguity.” Dr. Hirsh found it interesting that providers approached black patients the same way in both the wrist fracture and low back pain conditions. “So a different way

of looking at this interaction is to say that providers gave black patients the same pain intensity ratings and opioid treatment regardless of their pain condition,” he explained, “whereas pain conditions seemed to influence providers’ treatment for white patients [Figures, page 20]. “Clearly the effect of race on treatment decisions is complicated,” he added. “It’s not always just black versus white. The context seems to matter, too; in our see RACE page 20

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Ξ ϮϬϭϰ sĞĐƚŽƌ ^ƵƌŐŝĐĂů͕ >> ZĞĨĞƌĞŶĐĞƐ͗ ;ϭͿ ŽŽůĞǇ͕ t͘ ͘ ĂŶĚ WĂƌŬĞƌ͕ :͘ ͞hŶĚĞƌƐƚĂŶĚŝŶŐ ƚŚĞ DĞĐŚĂŶŝƐŵƐ ƌĞĂƟ ŶŐ &ĂůƐĞ WŽƐŝƟ ǀĞ >ƵŵƉĞĐƚŽŵǇ DĂƌŐŝŶƐ͘͟ American Journal of Surgery ϭϵϬ ;ϮϬϬϱͿ͗ ϲϬϲͲϲϬϴ͘ ;ϮͿ ƌŝƩ ŽŶ͕ W͘ ͖͘ ^ŽŶŽĚĂ͕ >͘/͖͘ zĂŵĂŵŽƚŽ͕ ͘<͖͘ <ŽŽ͕ ͖͘ ^ŽŚ͕ ͖͘ ĂŶĚ 'ŽƵĚ͕ ͘ ͞ ƌĞĂƐƚ ^ƵƌŐŝĐĂů ^ƉĞĐŝŵĞŶ ZĂĚŝŽŐƌĂƉŚƐ͗ ,Žǁ ZĞůŝĂďůĞ ƌĞ dŚĞǇ͍͟ European Journal of Radiology ϳϵ ;ϮϬϭϭͿ͗ ϮϰϱͲϮϰϵ͘ ;ϯͿ DŽůŝŶĂ͕ D͘ ͖͘ ^ŶĞůů͕ ^͖͘ &ƌĂŶĐĞƐĐŚŝ͕ ͖͘ :ŽƌĚĂ͕ D͖͘ 'ŽŵĞǌ͕ ͖͘ DŽī Ăƚ͕ &͘>͖͘ WŽǁĞůů͕ :͖͘ ĂŶĚ ǀŝƐĂƌ͕ ͘ ͞ ƌĞĂƐƚ ^ƉĞĐŝŵĞŶ KƌŝĞŶƚĂƟ ŽŶ͘͟ Annals of Surgical Oncology ϭϲ ;ϮϬϬϵͿ͗ ϮϴϱͲϮϴϴ͘ ;ϰͿ DĐ ĂŚŝůů͕ >͘ ͖͘ ^ŝŶŐůĞ͕ Z͘D͖͘ ŝĞůůŽ ŽǁůĞƐ͕ ͘:͖͘ &ĞŝŐĞůƐŽŶ͕ ,͘^͖͘ :ĂŵĞƐ͕ d͘ ͖͘ ĂƌŶĞǇ͕ d͖͘ ŶŐĞů͕ :͘D͖͘ ĂŶĚ KŶŝƟ ůŽ͕ ͘ ͘ ͞sĂƌŝĂďŝůŝƚǇ ŝŶ ZĞĞǆĐŝƐŝŽŶ &ŽůůŽǁŝŶŐ ƌĞĂƐƚ ŽŶƐĞƌǀĂƟ ŽŶ ^ƵƌŐĞƌǇ͘͟ :ŽƵƌŶĂů ŽĨ ƚŚĞ ŵĞƌŝĐĂŶ DĞĚŝĐĂů ƐƐŽĐŝĂƟ ŽŶ ϯϬϳ͘ϱ ;ϮϬϭϮͿ͗ ϰϲϳͲϰϳϱ͘

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Fecal Transplants for IBD Show Mixed Results in Trials B Y D AVID W ILD CHICAGO—Fecal transplant has reached a critical milestone: testing in the first randomized controlled trial of the therapy to treat inflammatory bowel disease. Although this step might be good for science, the news was not quite so encouraging for patients. The treatment did not appear to be better than placebo transplant at alleviating symptoms of ulcerative

colitis (UC), according to the researchers. “Although we did not find a statistically significant effect of FMT [fecal microbiota transplantation] in active UC, there is the possibility that FMT may be effective when administered longer than six weeks,” the researchers said, noting that there were no major adverse events. The study, led by Paul Moayyedi, MBChB, PhD, MPH, acting director of the Farncombe Family Digestive Health Research Institute and director of the

Division of Gastroenterology at McMaster University, in Hamilton, Ontario, Canada, was one of several trials of FMT whose results were presented at Digestive Disease Week (DDW) 2014. In the trial, the researchers randomized 27 patients with mild to moderate UC to receive an FMT enema and 26 patients to receive a placebo enema, both once weekly for six weeks (abstract 929c). The patients had active disease, with Mayo scores of 4 or higher and endoscopic Mayo scores of

1 or greater. Subjects had not used antibiotics within the month before FMT and had tested negative for Clostridium difficile. Roughly 45% in both groups had pancolitis. During the study, 42% of subjects received corticosteroids, 19% continued with immunosuppressive treatment and 9% continued with biologic therapy. The findings showed that four FMT recipients (15%) and two placebo subjects (8%) achieved clinical remission, defined as a Mayo score of 2 or less and an endoscopic Mayo score of 0, a difference that was not statistically significant. Seven FMT patients (26%) and eight placebo recipients (31%) experienced improvements of at least 30% in their Mayo scores. But FMT might be more effective with increasing treatment duration. In a subanalysis, 16 FMT recipients who reported subjective improvements after initial treatment, but did not achieve clinical and endoscopic remission, continued with six to 12 weeks of additional therapy. Five of these patients subsequently experienced clinical remission. In a separate, open-label study, seven UC patients received a single FMT infusion colonoscopically (abstract Su1403). Scores on the Ulcerative Colitis Disease Activity Index (UCDAI) and histologic results of rectal biopsies were obtained before and one month after FMT. One patient experienced remission at one month, with a drop in UCDAI score from 8 to 2 and resolution of histologic inflammation, but did not maintain remission. “Among all patients, there was a statistically significant drop in UCDAI scores at one month and a trend toward improvement in histologic scores,” the investigators said, adding that one patient experienced a colonoscopy-related perforation and was excluded from the analysis. The variation in responses in these studies points to the need to refine FMT protocols, said Lawrence J. Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine and emeritus chief of the Division of Gastroenterology at Montefiore Medical Center, in New York City. “These studies all show that FMT may have a therapeutic role in treating IBD, but the precise patients for whom it is best

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

suited and the best approach to administering it need to be further studied,” said Dr. Brandt, who was not involved in the latest research. Although Crohn’s disease “is overall less responsive to FMT,” as a recent review stated ((J Clin Gastroenterol May 22, 2014 [Epub ahead of print]), findings from a pair of studies presented at DDW help tip the balance in favor of a place for FMT in the treatment toolbox for the disease. In one study, eight patients with active Crohn’s disease received a single FMT infusion colonoscopically in an open-label fashion (abstract Mo1228). The patients had a median score on the Harvey-Bradshaw Index (HBI) of 8 at baseline, indicating mild to moderate disease severity. Before FMT, no patients received biologics, antibiotics, probiotics or steroids at a dose greater than 20 mg per day. The investigators documented scores on the HBI, the Crohn’s Disease Endoscopic Index of Severity (CDEIS) and the short Inflammatory Bowel Disease Questionnaire (sIBDQ), which measures quality of life, at baseline and up to three months for some patients. They also documented levels of C-reactive protein (CRP), a marker of inflammation. At the follow-up visit at four weeks, five patients (62%) achieved clinical remission, defined as an HBI score less than 5, and there were significant decreases in CRP levels and improvements in sIBDQ scores. Data from four patients monitored eight weeks after FMT and two patients monitored at 12 weeks showed that all of these individuals were in clinical remission. However, two patients required an increase in their Crohn’s medication within four weeks of FMT. Consistent with other FMT safety data presented at DDW, the researchers said there were no serious adverse events. “These preliminary results suggest FMT is safe and can induce early improvements in symptoms in patients with active [Crohn’s disease],” the investigators said. “Whether the improvements can be sustained, and whether they correlate with objective [endoscopic] measures of inflammation, still need to be determined.” FMT was mostly effective in inducing remission in a group of nine children and adolescents with mild to moderate CD, who received a single transplant

nasogastrically (abstract Tu1754). These patients, who were between 12 and 19 years old, received a three-day course of rifaximin before FMT as well as omeprazole the day before FMT. The investigators found that mean scores on the Pediatric Crohn’s Disease Activity Index (PCDAI) dropped from 19.7 (±7.2) at baseline to 6.4 (±6.6) after two weeks, rising slightly to 8.6 (±4.9) at six weeks. That difference was not statistically significant. Moreover, seven patients (78%) were in clinical remission two weeks after FMT, defined as a PCDAI score of 10 or lower. Two of these patients

relapsed six weeks after FMT, and five patients required maintenance drug therapy by that time. “It’s the experience of the few researchers looking at FMT for IBD that, unlike the single administration of FMT that’s required for Clostridium difficile treatment, some IBD patients likely need several infusions to induce remission and most patients require ongoing maintenance FMT,” Dr. Brandt said. He noted that he has seen mixed results in his own Crohn’s patients to whom he has administered FMT. “The success of FMT in both Crohn’s

disease and ulcerative colitis patients may have to do with disease characteristics, such as precipitating factors, genetics, age at onset, disease duration and severity, location of disease and perhaps the patient’s intestinal microbiota,” Dr. Brandt said. “It may be that we need to look at the patient’s unique bacterial composition and determine which organisms need to replaced, and formulate FMT accordingly.”

Dr. Brandt has served as an advisor for CIPAK.

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In the News LAP CHOLE

jContinued from page 1 enrolled 65 outpatients, American Society of Anesthesiologists (ASA) physical status 1 to 3, scheduled for laparoscopic cholecystectomy, into the trial. Each patient received a regimen of an opioid and an inhalational anesthetic, with preemptive antiemetics based on preoperative PONV risk according to ASA guidelines. The intervention group of 32 patients received 1,000 mg of IV acetaminophen (Ofirmev, Cadence Pharmaceuticals) after removal of the gallbladder but before emergence. The control group of 33 patients received opioids and other analgesics, including ketorolac, as per usual practice. Pain scores were recorded with an 11-point rating scale before surgery and at 10-minute intervals in the PACU. Both PDNV and patient satisfaction were assessed within seven days of surgery. “We wanted to measure the effect of giving an intraoperative dose of Ofirmev versus just giving standard, opioid-based analgesics that clinicians would typically give for these cases,” Dr. Bosshart explained. “We picked this particular procedure because it’s one of the most commonly performed surgeries in the outpatient setting.” As Dr. Bosshart reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-29), PACU pain scores did not differ significantly between the IV acetaminophen patients and the controls at 10 minutes (1.4±3.1 vs. 2.3±3.0, respectively; P=0.12) or one hour after surgery (2.6±2.5 vs. 2.1±2.3, respectively; P=0.77). Total opioid use (intraoperative plus PACU) as measured by morphine equivalents also was comparable between groups (72±36 vs. 69±36 mg, respectively; P=0.9). Trends toward less PONV were observed in the PACU, with 36% of controls experiencing the side effect compared with 21% of the treatment group ( =0.3). Similar results were found for (P PDNV, which affected 38% of controls and 14% of patients receiving IV acetaminophen ((P=0.08). “We also found that PDNV was actually more prolonged in the control group,” Dr. Bosshart said. Indeed, 24% of controls reported PDNV on the day of surgery, with 7% and 7% reporting the adverse event on postoperative days 2 and 3, respectively. “In the IV acetaminophen group,” he said, “it was only noted on the actual day of surgery [P<0.05].” Patient satisfaction with pain control, PONV management and overall experience also trended in favor of IV acetaminophen, although this did not reach significance: 67%, 71% and 84%, respectively, for controls versus 84%, 93% and

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

96% for the treatment group (P=0.5, 0.1 and 0.4). “We found the effect of the IV acetaminophen on nausea particularly interesting … not only initially, but also after discharge,” he said. “It was equally interesting that overall patient satisfaction was higher in the treatment group, despite the actual perception of the pain being similar in both groups. We expect these differences to reach statistical significance once we finish enrollment. “These preliminary results seem to demonstrate that there’s another factor involved here with regard to PONV

’The problem with looking at postdischarge results is that they will be somewhat affected by what the surgeon prescribes after the surgery.’ —Raafat Hannallah, MD than just opioid sparing,” Dr. Bosshart added. “It seems there is a central effect that may have something to do with a

metabolite of acetaminophen and how it affects cannabinoid receptors in the brain.” The study is ongoing. Session moderator Raafat Hannallah, MD, professor of anesthesiology and pediatrics at Children’s National Health System, in Washington, D.C., proposed a possible confounding factor that may have influenced the results. “The problem, of course, with looking at postdischarge results is that they will be somewhat affected by what the surgeon prescribes after the surgery. These agents will be responsible for at least some of the observed response.”

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Visit Ethicon.com for more information. *Data from a prospective, longitudinal study of 71 patients receiving open hernia repair with ULTRAPRO® Plug from the International Hernia Mesh Registry. Two additional patient-reported recurrences could not be medically confirmed by a clinician.4 References: 1. Tsirline VB, Colavita PD, Belyansky I, Zemlyak AY, Lincourt AE, Heniford BT. ULTRAPRO Hernia System versus conventional Lichtenstein repair for inguinal hernia system: results from the multinational registry. Abstract presented at 5th International Hernia Congress; March 28-31, 2012; New York, NY. 2. Berrevoet F, Tollens T, Romanowski C, Jones P, McRoy L. Open macroporous partially absorbable flat mesh — 12 month outcomes. Poster presented at 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 3. Lorenz R, Koch A, Wiese M, Born H. Gilbert repair — a new gold standard? First results of 2792 patients of a multicentric German quality control study. Poster presented at 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 4. Doerhoff C, Lydon P, Hammond J, Romanowski C, Jones P. 12 month outcomes following open hernia repair with a partially absorbable plug and patch device. Abstract presented at the 36th Annual International Congress of the European Hernia Society; May 28-31, 2014; Edinburgh, Scotland. 5. Data on file. Mesh Specifications. Ethicon, Inc. For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert. © 2014 Ethicon, Inc. All rights reserved. 017076-140616

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Medicaid Payment Tied to Timing of Breast Cancer Surgery B Y K ATE O’R OURKE CHICAGO—In states where surgeons receive lower Medicaid reimbursements for breast cancer surgery, Medicaid patients have longer wait times for breastconserving surgery and outpatient mastectomies. This news comes from a study presented at the recent annual meeting of the American Society of Clinical Oncology by researchers from RTI International,

Research Triangle Park, N.C. About 20% of people in the United States were enrolled in Medicaid for at least one month in 2010. The researchers conducted the study because there is a large variability in Medicaid policies. As long as states meet certain requirements set by the federal government, they have the flexibility to determine which patients are eligible for Medicaid and how much physicians will be reimbursed for services.

Previous studies have shown that Medicaid patients are more likely to receive some medical services, such as cancer screenings, in states that have higher Medicaid reimbursements. To find out how payment policies affect the receipt of breast cancer surgery, the investigators analyzed data from women between the ages of 18 and 64 who were enrolled in fee-for-service Medicaid for at least four months between 2006 and 2008, in 46 states or Washington, D.C.

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The study focused on breast cancer patients who had at least two claims with diagnostic codes on different dates before a claim for mastectomy or breast-conserving surgery. The study included 3,272 women who received breast-conserving surgery; 2,156 who received an outpatient mastectomy; and 2,114 who received an inpatient mastectomy. In states with lower reimbursements, patients were more likely to experience longer wait times for breast-conserving surgery (r= –0.32; P<0.05) and outpatient mastectomy (r= –0.41; P<0.005). There was no statistically significant association between timing for inpatient mastectomy and reimbursement. According to Michael Halpern, MD, PhD, a senior fellow with RTI International, who presented the study, one explanation for the finding is that surgeons who accept Medicaid patients have busier caseloads and greater waiting periods. When Medicaid reimburses doctors at higher rates, more doctors may be willing to take on Medicaid patients, which will reduce overall waiting times. The study also found that beneficiaries in states with Medicaid eligibility recertification every 12 months had a shorter time to all three types of breast cancer surgery than states that required recertification more frequently. “We think there are substantial policy implications for this,” said Dr. Halpern. “Increasing Medicaid reimbursement may increase the number of surgeons who accept Medicaid patients, and consequentially decrease time from diagnosis to surgery. Requiring recertification annually rather than a shorter [time period] may lead to more stability of care.” According to Dr. Halpern, given that the Affordable Care Act will substantially expand Medicaid, state policymakers need to consider approaches to improve access to high-quality cancer care for this underserved population. Sandra Wong, MD, MS, associate professor of surgery, University of Michigan Health System, Ann Arbor, said the research was important. “I think this study clearly demonstrates that Medicaid reimbursement levels seem to be tied to delays in surgical treatment and, as a result, probably downstream impact on patient outcomes whether that be morbidity or mortality,” she said. Dr. Wong pointed out that the study provided no information on the provider perspective on systems issues. “It is uniquely important to look at/compare how other payor systems/levels of reimbursement impact time to treatment,” she said. She said policies are needed to eliminate barriers across patients for receipt of care in breast cancer and other cancers.

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Duke Protocol Reduces Colorectal Surgical Site Infections by 75% B Y M ARIE R OSENTHAL

bundle of preventive measures can significantly reduce surgical site infections (SSIs) after colorectal surgery, but the strategy probably requires a “village” to be successful, a new study suggested. “You cannot do this alone,” said co-investigator Christopher R. Mantyh, MD, a colorectal surgeon and surgical oncologist in the Department of Surgery, Duke University Medical Center in Durham, N.C. “I had a lot of buyin from people, and there was not much pushback at all.” In the study, a group of preventive measures were bundled and implemented pre-, during and post-colorectal surgery, which resulted in an almost 75% reduction in both superficial SSIs (5.7% after the intervention vs. 19.3% before; P<0.001) and postoperative sepsis (2.4% vs. 8.5%; P P=0.009) (JAMA Surgg 2014 Aug. 27. [Epub ahead of print]). Bundles, which combine specific interventions, have become popular in infection control, according to Joseph Kuti, PharmD, associate director of clinical and economic studies at the Center for Anti-Infective Research and Development at Hartford Hospital in Hartford, Conn., whose area of research is the use of bundles to improve outcomes in patients with infection. “By putting the bundle through as a package, the intent is that every single piece of the bundle will be followed,” said Dr. Kuti. “We think the sum is greater than the whole,” Dr. Mantyh explained. “If you did one [intervention], you might see a small improvement. If you add together five or 12 of these actions, there is an even greater improvement. I do not think any one action would move the needle significantly.” The first step was recognizing this as a problem and not the norm. “It was an acceptable fact of life that when you operated on the colon or the rectum, you would see a surgical site infection in about one-fourth of your patients,” Dr. Mantyh said. After Duke began participating in the American College of Surgeons National Surgical Quality Improvement Program, the physicians became aware that their 20% rate of infection was a little higher than some other institutions. “When I initially tried to start this in 2010, I was kind of doing this on my own, and I met a lot of failure,” Dr. Mantyh admitted. “My realization was that I had to involve other folks, such as nursing and anesthesia, and once I did that, it became a lot easier.”

The (Medical) Village A multidisciplinary team, including surgeons, anesthesiologists, clinic nurses, operating room (OR) staff, unit nurses, house staff and hospital midlevel providers were involved in either putting together the bundle or its implementation. The team looked at the entire colorectal surgery process from pre-op to post-op before deciding which measures to include in the bundle (Table). Some of the measures were evidence-based and others were commonsense ideas that presented little patient risk, but had a potential of reducing infections, Dr. Mantyh told General Surgery News. “We chose these [actions] for our bundle because they were easy to do, low cost and everyone was on board with them,” he said. (The largest cost was a $10,000 outlay for 10 fascial closure tray packages.)

There were a few areas that saw some heavy discussion among team members. One was the use of mechanical bowel preparation and prophylactic antibiotics. “This is a controversial area,” Dr. Mantyh said. “There are some studies that show it does not improve SSI rates, maybe even makes them worse and some that show it does [improve rates]. But the most recent data that have come out in the last few years [Dis Colon Rectum. 2012;55:11601166] indicate that it is beneficial to decrease the SSI rates if you provide the bowel prep with antibiotics.” After a discussion with the infectious disease staff, the team also decided to limit OR traffic. “Anesthesia and surgery had to get together and make sure we did not have extraneous people coming and going through the OR because the ID [infectious disease] people said that was a great way to introduce airborne bacteria into your room,” he said. Another controversial area was the use of fascial wound protectors with reports in the literature both supporting and not endorsing their use. “We felt that if we began to use them especially for our open cases, it could decrease the bacterial count in the subcutaneous space.” Dr. Mantyh said. The input surrounding the antibiotic choice demonstrates the type of interaction that was used throughout the process. As a teaching hospital, residents are frequently the ones providing postoperative care at Duke. “We found that our residents were redosing antibiotics inappropriately,” he said. A discussion with the infectious disease physicians led to the idea of using ertapenem (Invanz, Merck) because it is only dosed once before surgery. When they talked with the pharmacist, however, there was some concern about super selection of bacteria with this drug. But a review found that this was not an issue at Duke, so the idea was brought before the team and added to the bundle. “The great thing about ertapenem is you give one dose preoperatively and that’s it. With that single act, we got in compliance with perioperative antibiotics,” Dr. Mantyh said.

Duke’s Preventive SSI Bundle Pre-op (5 measures) 1. Educate patients about SSI preventive measures and objectives 2. Have patient shower with chlorhexidine 3. Perform mechanical bowel prep with oral antibiotics 4. Administer ertapenum within 1 h of incision 5. Standardize preparation of surgical field with chlorhexidine alcohol

During surgery (6 measures) 1. Use fascial wound protector 2. Change gown and gloves before fascial closure 3. Have a dedicated wound-closure tray 4. Limit OR traffic 5. Maintain euglycemia 6. Maintain normothermia during surgery

Post-op (5 measures) 1. 2. 3. 4.

Remove sterile dressing within 48 h Wash incision daily with chlorhexidine Maintain euglycemia Maintain normothermia in the early preoperative period 5. Reinforce patient education about SSI preventive measures and objectives. Source: JAMA Surgery 2014 Aug. 27. [Epub ahead of print].

They began implementing the bundle on July 1, 2011 and the adherence to the protocol was very high. In addition to the staff buy-in, the bundle had a champion in Dr. Mantyh, who met regularly with various departments to review recent SSI results and address any implementation problems. The use of the team approach to determine and implement the bundle and the champion were probably instrumental in the program’s success, according to Dr. Kuti. “This is about culture change,” Dr. Kuti said. “You need lots of education, and the support from key opinion leaders, well-respected individuals and the administration. Then you need to collect data and analyze that data after implementation to demonstrate the intervention worked and can therefore be expanded—in this case, expanded to the other colorectal surgeons.”

‘Phenomenal’ Results To determine whether the bundle helped reduced SSIs, the Duke researchers conducted a retrospective study and looked at procedures performed between Jan. 1, 2008 and Dec. 31, 2012. They reviewed the medical records of 559 patients—346 underwent colorectal surgery before implementation of the bundle and 213 underwent surgery after implementation—and found that the bundle was associated with a substantial reduction in SSIs. Indeed, the nearly 75% reduction in SSIs documented in the JAMA Surgeryy study was “a phenomenal” result, said Ira L. Leeds, MD, MBA, who wrote an accompanying editorial in the journal. But he stressed that “one needs to interpret them in the right context. Their SSI rate going into the [research] was something they made an intentional effort to reduce.” Results like this require changing behavior and that can be difficult, especially in medicine, added Dr. Leeds, the Halsted Surgical Resident at Johns Hopkins University School of Medicine. “Even within a single health care institution, there are awfully high fences between departments, and these firm and sharp divisions really make it difficult to implement something system-wide. “This bundle was built from the ground up. There was a physician champion, but he got buy-in from the nursing staff, the techs. On top of that, they invited comment from all the people who are involved in the procedure,” he said, adding that the future of quality improvement in health care will require grass roots interventions like this. For Duke, Dr. Mantyh said, the bundle has become the standard of care for colorectal surgery, and surgeons in other areas with a high SSI rate are reviewing the results. “We are beginning to look at these other areas, but each is a little different,” he said, so the bundle would have to be tweaked by the staff in that department. Dr. Leeds said that is the way infection prevention should be done. These interventions are less about duplication and mandates and more about a process and buyin, he explained. “When the people who are ultimately responsible for the performance measure are the people designing the program, it becomes infused with a sense of ownership you cannot mandate.” He said people lampoon “committee think,” but a deliberative process can help improve quality. “Everyone in the operating room plays a very specific role, and they see things from very different perspectives. Unless you engage each of those individuals, you are going to end up with a solution that is not optimized for each individual’s role.”

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Operative Report

y l l a c i t i l o P e e h v i T t a r e p O t c e r Cor t r o p e R MD , n o d r o A. By Leo

Preoperative1 diagnosis2: Carcinoma3 of the Right Colon4 Postoperative 5 diagnosis: Carcinoma of the Right Colon Procedure: Right Colectomy6 Surgeon7: Leo A. Gordon,8 MD9 Estimated blood10 loss: 25011 cc Intraoperative12 Complications: None Indications: This 6813 y/o W14 F15 presented with anemia.16 A barium enema 17 revealed a cecal18 lesion. Findings: A bulky, transmural19 cecal carcinoma was found.

Procedure: With the patient in the supine20 position, the abdomen21 was prepared and draped in the usual22 fashion. A right mid-abdominal transverse incision23 was made, dividing the subcutaneous tissues.24 The fascia of the right rectus muscle was identified and divided. The rectus and lateral body wall muscles25 were divided. The peritoneal cavity was entered. A bulky cecal carcinoma was found. There was no evidence of liver metastases, peritoneal seeding or ascites.26 The peritoneal attachments of the right colon were taken down. The hepatic flexure was mobilized, identifying the duodenum 27 and dissecting it inferiorly. After mobilizing the terminal ileum, 28 proximal and

distal transection points29 were identified. The terminal ileum was divided, as was the right transverse colon. This was done with the stapling device.30 The mesentery of the right colon was then divided, identifying the ileocolic vessels31 and doubly ligating them with 2-0 silk. A side-to-side ileo-colostomyy32 was then performed using a posterior row of 3-0 silkk33 and an inner-running34 suture of 3-0 chromic.35 The inner layer was continued anteriorly in a Connell36 fashion. The anterior outer layer of the anastomosis was completed with interrupted 3-0 silk in a Lembert37 fashion. The resultant mesenteric defect38 was closed with a running suture of 3-0 chromic. The abdomen was irrigated with saline.39 There was no evidence of bleeding in any areas of dissection. The abdomen was closed with a running No. 240 monofilament 41 suture to the anterior and posterior fascial layers.42 The skin was closed with the skin-stapling device.43 A dryy44 sterile45 pressure dressing was applied. The sponge and needle counts46 were reported as correct. The patient was transferred to the recovery room47 in stable condition.48 Leo A. Gordon, MD D: 2/14/14 T: 2/15/14 #78882577/op900056

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References [To the Politically Correct Operative Report] 1. I mean no d disrespect to any other type of diagnosis. The postoperative d diagnosis is particularly sensitive to this. The use of preoperativee is a necessary descriptive term and implies no lack of respectt for the operative or postoperative diagnosis. 2. No snub or prejudice is intended by using the term diagnosis. Prognosis h has made great strides over the past few years. I do not mean to discount or to impugn these accomplishments. 3. It is unfortu unate that other disease states could not be given credit in this ooperative report. The entire sarcoma family (leiomyo-, rhabdo--, and carcino-), not to mention the colitides (infectious and d ischemic) are all reputable and earnest diseases. 4. Although th he transverse and left colons are honest and reputable orgaans and have made great embryologic strides, they could nott be mentioned in this report. I do not mean to impugn their aabilities or strengths, nor do I mean any disrespect or offensse. 5. The postopeerative state is equal to the preoperative state under the Con nstitution of the United States. 6. There are m many operative procedures, each of which has its own strengths.. These procedures are equal. I mean no prejudice against th he left colectomy, the gastrectomy or the Nissen fundoplication n. Only mentioning the right colectomy may be construed in soome quarters as an unfair advantage to the right side of the coloon. This is unintentional. 7. The use of tthe term surgeon does not intend to discriminate against an ny other group. It is an unfortunate custom that this restrictive and culturally insensitive term is perpetuated in formal documeents such as operative reports. 8. Separating aan individual by name should not be construed as unfair to oth her people who are not Gordons. All Gordons are equall under the law, even my lazy uncle Phil who, although last eemployed in 1981, still refers to himself as “between jobs..” 9. Separating p people by abbreviations and degrees may be construed as elitistt. The use of this term is required by state law to show that a liccensed physician performed the surgery. I apologize for any peerceived slight to non-MDs. 10. I mean no disrespect to any other body fluid. 11. All integerrs deserve equal protection under the law. The use of the inteeger 250 should not upset 111, 238 or even 457. These are fine and able numbers. 12. The intraooperative state has not received any unfair advantage in this rep port. 13. The use off the number 68 should not be construed as “ageism.” The patient was, in fact, 68 years old. Despite many attempts to broaden the concept of “68” so as not to prejudice any memb ber of the health care team, its use was unavoidable. Nevertheeless, I have received many complaints from the AARP insistin ng that the term 68 led to preconceived notions that, with reasonable legal probability, might prejudice youthoriented operaating room personnel. 14. Many attem mpts at multicultural enhancement and sensitivity were made preoperatively. It was just impossible to convince the patient that she was anything but a Caucasian female. 15. The Preoperative Gender Awareness representative from the hospital visited the patient and counseled her that her gender would not work against her in the face of a male surgeon. All OR staff members were required to attend a gender awareness seminar before the performance of this case.

16. Polycythemia is good too. I mean no disrespect to pancytopenia or leukopenia. 17. No prejudice is to be implied by the use of this term. Colonoscopy is a good, honorable and committed procedure. 18. The cecum was the site of this lesion. I recognize the importance and contributions made by the splenic flexure, the hepatic flexure and the sigmoid. They are honest, hard-working colonic segments. 19. I mean no prejudice against flat, noninvasive lesions. 20. Prone is good. Left-lateral decubitus is good. Jackknife is good. I also want to mention Trendelenberg, reverse Trendelenberg, lithotomy, Simms and semi-Fowlers. These positions are good too. 21. Over the years, all body cavities have become important. I do not mean to denigrate the thorax or the cranium. 22. The unusual fashion is perfectly acceptable. I fully recognize the contributions of the unusual fashion and do not mean to relegate the unusual fashion to a subordinate status. 23. Incision choice is rife with prejudice and preconceived notions of superiority. Choosing a right mid-abdominal transverse incision was done only after recognizing the place of other incisions in a historical-surgical context. The many contributions to society by the midline incision were acknowledged, as were the contributions of the para-median, Rocky-Davis and the chevron. 24. Loose areolar tissue has always been low on the list. It should be higher. Regrettably, there was no way to weave it into this operative report. 25. A vicious letter to the OME (Office of Muscle Equality) was forwarded to me. It was written by the left trapezius alleging preferential treatment for the body wall musculature. 26. Metastases, seeding and ascites have all formed political action committees to further their cause. The fact that there was “no evidence” of these groups does not imply a lack of respect or admiration for their many fine accomplishments. 27. The specific identification of the duodenum should not be interpreted as prejudice against the right lobe of the liver, the head of the pancreas or the right kidney. 28. The proximal and mid-ileum have made significant contributions to the ileum. It is unfortunate that they could not be involved in a meaningful way in this operation. 29. Equal time was given to assessing both the proximal and distal transection points. 30. The contributions of any member of the American labor force engaged in nonstapling device production are recognized, appreciated and admired. 31. Why the ileo-colics?” I am asked. Why not a specific mention of each vessel to the right colon, such as arterioles to the cecum or marginal arteries? How about the submucosal vessels? Each of these vessels is important. Each, in an embryologic-sociologic-historical context deserves mention and adulation, although they were not specifically identified in this case. 32. I received an angry letter from the American End-to-End Lobbying Coalition in Washington decrying my use of this method. There is a rich cultural history to the end-to-end that I overlooked. My sincerest apologies to them. End-to-ends will be given preference from now on. 33. Rayon, dacron, velcro and polyester are good too.

34. No disrespect is intended toward interrupted suturing. 35. Molybdenum, titanium, lead and the entire periodic table of the elements should have been mentioned. I just ran out of trace elements. 36. The McArdles, O’Flahertys and MacDougalls had their own fashion. Each was proper, honest, hardworking and has made meaningful contributions to American surgery. 37. The Cocteaus, Rouleauxs, Flamberts and other French surgeons all made great contributions. I mean no disrespect, despite a vitriolic editorial against me in the Journal Lycee De Churgirie de France De Allemaigne. 38. Although “defect” has a negative connotation, it is used here to describe a hole resulting from the surgery. It is unfortunate that the Latin root of defect is defectuss meaning “to fail or to be wanting.” I mean no implied failure or lack of achievement of any group of organs or systems in using the term in this operative report. 39. Ringers lactate is fine. Water is good. It is incredibly unfair that the term salinee is still used. I am waiting for a better word to describe the original solution from which we all arose. 40. No. 3 is fine. No. 8 is great. All integers are equal. 41. Braided sutures deserve special consideration and must be viewed in a historical-societal context to bring them into mainstream surgery. The braideds have been paid less than the monofilaments. They, as immigrants, were discriminated against in the early part of the century. Using the term monofilament is a cultural judgment made by the operating surgeon, who must ultimately bear the responsibility of his suture selection. 42. Equal time and attention was given to both anterior and posterior layers. 43. The American suture worker is strong, talented and productive. The use of the stapling device should not be construed as reverse Luddism. 44. Wet is good too. 45. Partisan groups fostering the cause of germs ask, “What’s wrong with unsterile dressings?” They raise a good point. I will try, and will encourage my colleagues to try to incorporate more unsterile activities in the operating room to balance this obvious injustice. 46. Why are only sponges and needles important? Letters poured in from instruments, light fixtures, IV tubing, drapes, mops and Mayo stands (even a telegram from a towel clip) all wanting to know why they were not counted in this report. They all are important and will be incorporated via a three-year preferential phase into the counting process. 47. In America, all rooms are equal. Those rooms that feel they are not equal, or have been dealt some injustice in the past will be receiving patients in the future. I am having a bit of trouble suggesting the boiler room as an acceptable recovery room alternative. 48. Unstable and critical conditions have always been upset with the use of this term. When we refer to a condition, we use it as a descriptive, not historical term. Criticall and unstablee had their hey-day in the past and quite frankly now begrudge “stable.” The pofessors of American surgery will lead us into the 21st century holding high the banner of criticall and unstablee conditions.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

International Panel Forges Consensus on Early Rectal Cancer B Y V ICTORIA S TERN

ver the past 15 years, the treatment of rectal cancer has improved significantly with the emergence of new surgical techniques and technologies and as physicians have gained a greater understanding of disease pathology. Despite such improvements, considerable variation exists in how experts manage early rectal cancer. That is why Mario Morino, MD, M.Hon.AFC, chairman and director of Digestive and Minimal Invasive Surgery at University of Turin School of Medicine, Torino, Italy, and president of the European Association for Endoscopic Surgery (EAES), organized an international, multidisciplinary panel at the 2014 EAES meeting in Paris to help unify and optimize the treatment of early rectal cancer. After combing through the literature, the panel members presented the best recommendations for the perioperative care of early rectal cancer based on the existing evidence. “This consensus congress was a very positive experience on an important topic that needs robust guidelines,” said Regina Beets-Tan, MD, PhD, professor in the Department of Radiology, Maastricht University Medical & Oncology Center, The Netherlands. Yves Panis, MD, head of the Department of Colorectal Surgery, Beaujon

Hospital, Paris, agreed, stating, “It was a strong panel of surgeons, gastroenterologists, radiologists and pathologists who worked well together to answer all questions related to the treatment of early rectal cancer and to create the consensus guidelines.” But, Dr. Panis noted that for many statements, the level of evidence was low because few, if any, prospective randomized controlled studies exist. “Thus, a consensus was often based on literature reviews, retrospective studies and personal experience.” When defining an optimal effective preoperative workup, Dr. Beets-Tan reported that every patient should have a physical examination, a test for carcinoembryonic antigen levels, a digital rectal examination that may include a rigid proctoscopy and a total colonoscopy (level 2, grade B, consensus 100%). Additionally, Dr. Beets-Tan found strong evidence in favor of endoscopic ultrasound for staging small rectal tumors (T1) and magnetic resonance imaging (MRI) for staging T2 or large tumors (level 2, grade B, consensus 100%). “The imaging guidelines are strongly evidence-based for local tumor staging,” said Dr. Beets-Tan. But, she added, further work is required to detect lymph node metastases, and she is currently conducting a multicenter study in The Netherlands to validate the use of dynamic contrast-enhanced MRI. The panel then focused on delineating

the best method for treating early rectal cancer. “To me, the most important elements of the guidelines are defining the limits of local incision and choosing the best technique for patients,” Dr. Panis said. To this end, the panel said that local excision is most effective for treating T1 N0 lesions with favorable clinical and pathologic features (level 4, grade C, consensus 100%). For lesions with less favorable clinical and pathologic features, the panel advocated neoadjuvant therapy followed by local excision to preserve the rectum (level 2b, grade B, consensus 90.9%). When performing a local excision, Dr. Panis advised endoscopic submucosal dissection (ESD) or transanal endoscopic microsurgery (TEM) (level 4, grade C, consensus 90.9%). When comparing the efficacy of ESD and TEM, however, the evidence did not clearly favor one technique over the other: In a recent meta-analysis, experts found that TEM provided better R0 resection rates (88.5% vs. 74.6%; P<0.001) but worse recurrence rates (5.2% vs. 2.6%; P<0.001) (Surg Endoscc 2014;28:427-438). “Choosing the best technique for the patient is a critical element of care, and we need to adapt to each patient’s individual needs to achieve this goal,” Dr. Panis said. “Ultimately, the goal is to preserve the rectum in early rectal cancer.” For patients with T1-2 N0 rectal cancer who are considered high risk for surgery, the panel recommended using neoadjuvant chemoradiation therapy followed

by TEM (level 2b, grade B, consensus 90.9%). The panel cautioned, however, that until further evidence emerges, lowrisk patients should only undergo this procedure within a clinical trial setting. When determining when a more radical approach is warranted, Tonia YoungFadok, MD, FACS, FASCRS, professor of surgery and chair of the Division of Colon and Rectal Surgery, Mayo Clinic College of Medicine, Phoenix, reported the panel’s conclusion that complete resection of the rectum using total mesorectal excision, or TME, should be performed when biopsy and imaging indicate that local excision is inadequate or when local excision shows the lesion is more advanced than expected (level 2a, grade B, consensus 90.9%). Another reason to opt for a more invasive approach is patient preference. In terms of the patients’ quality of life after surgery, the evidence strongly points to laparoscopic over open surgery in most cases, considering the advantages of shorter length of stay and postoperative complications (level 1a, grade A, consensus 100%). Commenting on what the future holds, Dr. Panis said, “We will continue to review and revise the guidelines, but today the idea is to publish these recommendations quickly to help unite the treatment protocols for early rectal cancer worldwide.” The full consensus guidelines will be published within the year in Surgical Endoscopy.

Med Board Uses Humor—Lamely, Critics Say—To Pitch MOC BY TEG AGRES

hile controversy and serious debate continue to surround the issue of enhanced requirements for maintenance of certification (MOC), the American Board of Pediatrics (ABP) attempted a bit of summertime humor by emailing animated cartoons to its diplomates as reminders to complete their MOC requirements by year’s end. But some pediatricians—including those who say the ABP had threatened them with legal action over their anti-MOC organizing efforts—found the “Nick Jr.”–style cartoons to be, well, juvenile and offensive. “The cartoons appear to be designed for my youngest patients rather than their pediatrician,” said Joseph Zanga, MD, chief of pediatrics, Columbus Regional Healthcare System, in Columbus, Ga., and a former president of the American Academy of Pediatrics. “It makes me angry that they’d spend our money on

demeaning junk such as [this].” “I’m glad the ABP has a sense of humor, but I was not amused by the videos,” said Victor Strasburger, MD, distinguished professor of pediatrics and chief of adolescent medicine, University of New Mexico School of Medicine, in Albuquerque. “They could be spending their time reviewing how MOC works—or doesn’t work—and make it much more palatable to the average pediatrician.” In late June, the ABP emailed links to three short musical cartoons to about 15,000 pediatricians who had MOC requirements to fulfill in 2014. “Summer’s here and we’re having some fun!” the ABP said on its Facebook page. “We’ve created three MOC videos explaining requirements. The content in these videos may not pertain to every diplomate (so be sure to check your ABP Portfolio for YOUR specific requirement needs), but we hope you get a giggle to lighten your day.” The first animation featured “a friendly bluegrass farmer who can sure play

that banjo!” The second video presented a classical motet entitled, “If ye loves being certified …” The third was a rap song, peculiarly titled, “Now this is the story ALL about how my points got flipped, turned upside down … ” Virginia A. Moyer, MD, MPH, vice president for maintenance of certification and quality at the ABP, said the idea was to remind physicians of the December deadline for completing their Part 4 MOC requirements, which involve quality improvements performance in practice. “I wanted to send a ‘Harry Potter’–style ‘howler’ but couldn’t figure out a way to do it,” Dr. Moyer explained, referring to the magical letter that screams its written message to the unfortunate recipient. “The videos were one way to get their attention,” she said. Paul M. Kempen, MD, PhD, an anesthesiologist at the Cleveland Clinic, in Ohio, and an outspoken critic of MOC, said the cartoons are evidence that “the boards have become so arrogant that they

‘Half-hearted attempts at funny videos is not going in the right direction.‘ —Victor Strasburger, MD

feel they can use any means to force this [MOC] down the throats of physicians.”

Getting Into Trouble Over MOC In 2010, Dr. Zanga launched an Internet-based anti-MOC petition drive using his email account at Columbus Regional. “The communications director at ABP

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

called expressing concern,” Dr. Zanga said in an interview. “She stated that the information in the petition was blatantly wrong, bordering on libelous. The hospital was not happy and told me to take it down,” he said. After moving the petition to another website, Dr. Zanga said he collected 2,000 signatures opposing ABP’s enhanced MOC requirements. Dr. Moyer said she had “no information” about the matter, but noted that ABP did not have a communications director in 2010. In the April 2010 issue of Clinical Pediatrics, Dr. Strasburger coauthored a commentary with Donald E. Greydanus, MD, critical of both ABP and MOC as it was then being developed. In the commentary, titled “Maintenance of Certification: The Elephant in the Room,” they proposed several less burdensome ways by which pediatricians could demonstrate that they were keeping up with developments in the field (Clin Pediatrr 2010;49:307-309). “The ABP threatened to sue me personally and SAGE Publications [the journal publisher] for libel,” said Dr. Strasburger, who was also a member of the journal’s editorial board. “They demanded a retraction. It took SAGE countless hours to review the complaint. Obviously, they were not happy.” The lawsuit never materialized, and in July 2011, Dr. Strasburger wrote another editorial, “Ain’t Misbehavin’: Is It Possible to Criticize Maintenance of Certification (MOC)?” This time, the editorial was endorsed by 10 members of Clinical Pediatrics’’ editorial board. “The ABP has tried to shut down any disagreement or even discussion about MOC,” Dr. Strasburger’s editorial said. “Several petitions to put a moratorium on the MOC process have generated >2000 signatures; yet the ABP has tried to shut down Web sites and any discussion. Pediatricians initially train within an academic system that prides itself on questioning everything. MOC should be no exception” (Clin Pediatrr 2011;50:587-590). “I do know that the board [of directors] was very unhappy with the two editorials that Dr. Strasburger wrote,” Dr. Moyer said when asked to comment. “If there was any legal action, I know absolutely nothing about it,” she said. Formal legal action would have had to come before the board, which did not happen, she added. Dr. Moyer said she has “no access” to any informal communications that may have occurred with Dr. Strasburger at the time. “No one should feel threatened about speaking their mind about something,” she said. “We really want the same thing; we all want pediatricians to be keeping up and improving the quality of their care.” However, according to Dr. Strasburger, “the threatened lawsuit shows that the ABP doesn’t have much of a sense of humor. It needs to look critically at

the product it’s producing, like all of the medical boards need to do, and see how to make it more user-friendly. Making half-hearted attempts at funny videos is not going in the right direction. Pediatricians are very upset about this but feel they are powerless,” he said. “What does a single practicing pediatrician do? They feel completely helpless.”

MOC Required for Licensure? In January, the American Board of Medical Specialties (ABMS) approved new MOC standards that emphasize continuous learning and assessments.

The new standards are to be adapted and implemented by each specialty board starting Jan. 1, 2015. Backlash in some specialties has been accelerating. For example, an ongoing petition drive protesting new MOC requirements by the American Board of Internal Medicine had collected so many signatures that in April, ABIM President Richard J. Baron, MD, issued a lengthy statement defending the organization’s efforts. As of July 2014, the petition had 17,400 signatures. Alarmed over escalating MOC requirements, including the apparent melding of MOC with maintenance

of licensure requirements, the American Medical Association’s House of Delegates approved several resolutions in June. They included opposing mandatory MOC in favor of self-regulation, the establishment of a “critical review” of the effect of MOC on physician practice and patient outcomes, and a resolution opposing mandatory participation in MOC as a condition for licensure. The delegates directed AMA to “oppose mandatory MOC as a condition of medical licensure, and encourage physicians to strive to constantly improve their care of patients by the means they find most effective.”

Experience the ENTEREG EFFECT Accelerate your patients’ upper and lower GI recovery in surgeries that

include bowel resection

› In clinical trials, ENTEREG reduced mean time to GI recovery by 11-31.5 hours vs. placebo.1

FIRST & ONLY agent of its kind ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis.

Important Safety Information for ENTEREG

› ›

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. No increased risk was observed in short-term trials. Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) ENTEREG REMS Program.

Contraindications

› ENTEREG Capsules are contraindicated in patients who have

taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG.

Warnings and Precautions

› There were more reports of myocardial infarctions in patients

treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established.

› ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week

›

prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (e.g., abdominal pain, nausea and vomiting, diarrhea). ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction.

Adverse Reactions

› The most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo among ENTEREG treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%).

E.A.S.E.® Program for ENTEREG

› ENTEREG is available only to hospitals that enroll in the E.A.S.E. ENTEREG REMS Program. To enroll in the E.A.S.E. Program, the hospital must acknowledge that:

– Hospital staff who prescribe, dispense, or administer

ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use

– Patients will not receive more than 15 doses of ENTEREG – ENTEREG will not be dispensed to patients after they have been discharged from the hospital

Please see following brief summary of Prescribing Information. Reference: 1. ENTEREG (Prescribing Information). Cubist Pharmaceuticals, Inc.; Lexington, MA.

In the News RACE

jContinued from page 9 study, the clinical situation mattered. And that’s particularly important in pain management, because pain is not always a cut-and-dried situation.” Although these results do not shed clear light on what influences providers’ decisions, they represent an important step in informing efforts to reduce disparities and improve pain care, Dr. Hirsh said. “How do we solve this?” he asked. “First, we need to understand it better.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

More research allows for better-tailored solutions.” Salimah H. Meghani, PhD, associate professor of nursing at the University of Pennsylvania, in Philadelphia, noted that 30 years of research has demonstrated that pain disparities are a very real phenomenon. “Dr. Hirsh’s study is important as it points to nuances in explaining these disparities, especially the critical role of ‘ambiguity’ in clinical decision making,” Dr. Meghani said. “The direction of some of the findings, however, is in contrast with our previous work.” Indeed, a meta-analysis conducted by

Dr. Meghani and her colleagues of analgesic treatment disparities in the United States (Pain Med 2012;13:150-174) found that black–white disparities were present for all types of pain, but were starkest for ambiguous pain types such as abdominal or low back pain. “The differences noted in Dr. Hirsh’s study may be related to the vignette nature of the study or that we don’t completely understand the relation between explicit and implicit bias,” Dr. Meghani explained. “However, the fact that white patients were given more high-intensity pain ratings and more opioid medications than black

patients despite wrist fracture is consistent with our findings. This is concerning because treatment differences exist even when the cause of pain is readily verifiable.” Identifying the genesis of these types of disparities is wound tightly into social processes, she added. “Research remains scarce on successful models for health [care] provider sensitization and education to overcome these disparities.” Key:

White

Black

100

BRIEF SUMMARY

There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG®, no increased risk of myocardial infarction was observed [see Warnings and Precautions (5.1)]. ] Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.®) Program [see Warnings and Precautions (5.1) and (5.2)]. ] 1

INDICATIONS AND USAGE ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. 4 CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG [see Warnings and Precautions (5.3)].] 5 WARNINGS AND PRECAUTIONS 5.1 Potential Risk of Myocardial Infarction with Long-term Use There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established. ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals [see Warnings and Precautions (5.2)]. 5.2 E.A.S.E. ENTEREG REMS Program ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) ENTEREG REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG [see Warnings and Precautions (5.1)]. Notable requirements of the E.A.S.E. Program include the following: ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the E.A.S.E. program may use ENTEREG. To enroll in the E.A.S.E. Program, an authorized hospital representative must acknowledge that: hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use; patients will not receive more than 15 doses of ENTEREG; and ENTEREG will not be dispensed to patients after they have been discharged from the hospital. Further information is available at www.ENTEREGREMS.com or 1-877-282-4786. 5.3 Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients Patients recently exposed to opioids are expected to be more sensitive to the effects of μ-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would be related to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials. Therefore, if ENTEREG is administered to these patients, they should be monitored for gastrointestinal adverse reactions. ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. 5.4 Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma levels of drug have been observed in such patients compared with patients with normal hepatic function. Therefore, the use of ENTEREG is not recommended in this population. 5.5 End-Stage Renal Disease No studies have been conducted in patients with end-stage renal disease. ENTEREG is not recommended for use in these patients. 5.6 Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. ENTEREG is not recommended for use in these patients. 5.7 Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses ENTEREG has not been studied in patients having pancreatic or gastric anastomosis. Therefore, ENTEREG is not recommended for use in these patients. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. The data described below reflect exposure to ENTEREG 12 mg in 1,793 patients in 10 placebo-controlled studies. The population was 19 to 97 years old, 64% were female, and 84% were Caucasian; 64% were undergoing a surgery that included bowel resection. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment). Among ENTEREG-treated patients undergoing surgeries that included a bowel resection, the most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). Adverse reactions are events that occurred after the first dose of study medication treatment and within 7 days of the last dose of study medication or events present at baseline that increased in severity after the start of study medication treatment. 7 DRUG INTERACTIONS 7.1 Potential for Drugs to Affect Alvimopan Pharmacokinetics An in vitroo study indicates that alvimopan is not a substrate of CYP enzymes. Therefore, concomitant administration of ENTEREG with inducers or inhibitors of CYP enzymes is unlikely to alter the metabolism of alvimopan. 7.2 Potential for Alvimopan to Affect the Pharmacokinetics of Other Drugs Based on in vitroo data, ENTEREG is unlikely to alter the pharmacokinetics of coadministered drugs through inhibition of CYP isoforms such as 1A2, 2C9, 2C19, 3A4, 2D6, and 2E1 or induction of CYP isoforms such as 1A2, 2B6, 2C9, 2C19, and 3A4. In vitro, ENTEREG did not inhibit p-glycoprotein.

ENTEREG and E.A.S.E. are registered trademarks of Adolor Corporation, a wholly owned subsidiary of Cubist Pharmaceuticals, Inc. Any other trademarks are property of their respective owners. Manufactured for: Cubist Pharmaceuticals, Inc. Lexington, MA 02421 USA October 2013

VAS Rating

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY

Effects of Alvimopan on Intravenous Morphine Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with alvimopan. 7.4 Effects of Concomitant Acid Blockers or Antibiotics A population pharmacokinetic analysis suggests that the pharmacokinetics of alvimopan were not affected by concomitant administration of acid blockers or antibiotics. No dosage adjustments are necessary in patients taking acid blockers or antibiotics. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B Risk Summary: y There are no adequate and/or well-controlled studies with ENTEREG in pregnant women. No fetal harm was observed in animal reproduction studies with oral administration of alvimopan to rats at doses 68 to 136 times the recommended human oral dose, or with intravenous administration to rats and rabbits at doses 3.4 to 6.8 times, and 5 to 10 times, respectively, the recommended human oral dose. Because animal reproduction studies are not always predictive of human response, ENTEREG should be used during pregnancy only if clearly needed. Animal Data: Reproduction studies were performed in pregnant rats at oral doses up to 200 mg/kg/day (about 68 to 136 times the recommended human oral dose based on body surface area) and at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) and in pregnant rabbits at intravenous doses up to 15 mg/kg/day (about 5 to 10 times the recommended human oral dose based on body surface area), and revealed no evidence of impaired fertility or harm to the fetus due to alvimopan. 8.3 Nursing Mothers It is not known whether ENTEREG is present in human milk. Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats. Exercise caution when administering ENTEREG to a nursing woman [see Clinical Pharmacology (12.3)]. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Of the total number of patients in 6 clinical efficacy studies treated with ENTEREG 12 mg or placebo, 46% were 65 years of age and over, while 18% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment based on increased age is required [see Clinical Pharmacology (12.3)]. 8.6 Hepatic Impairment ENTEREG is not recommended for use in patients with severe hepatic impairment. Dosage adjustment is not required for patients with mild-to-moderate hepatic impairment. Patients with mild-to-moderate hepatic impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].] 8.7 Renal Impairment ENTEREG is not recommended for use in patients with end-stage renal disease. Dosage adjustment is not required for patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. Patients with severe renal impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Clinical Pharmacology (12.3)]. 8.8 Race No dosage adjustment is necessary in Black, Hispanic, and Japanese patients. However, the exposure to ENTEREG in Japanese healthy male volunteers was approximately 2-fold greater than in Caucasian subjects. Japanese patients should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Clinical Pharmacology (12.3)]. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: g Two-year carcinogenicity studies were conducted with alvimopan in CD-1 mice at oral doses up to 4000 mg/kg/day and in Sprague-Dawley rats at oral doses up to 500 mg/kg/day. Oral administration of alvimopan for 104 weeks produced significant increases in the incidences of fibroma, fibrosarcoma, and sarcoma in the skin/subcutis, and of osteoma/osteosarcoma in bones of female mice at 4000 mg/kg/day (about 674 times the recommended human dose based on body surface area). In rats, oral administration of alvimopan for 104 weeks did not produce any tumor up to 500 mg/kg/day (about 166 times the recommended human dose based on body surface area). Mutagenesis: g Alvimopan was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/−) forward mutation test, the Chinese Hamster Ovary (CHO) cell chromosome aberration test, or the mouse micronucleus test. The pharmacologically active ‘metabolite’ ADL 08-0011 was negative in the Ames test, chromosome aberration test in CHO cells, and mouse micronucleus test. Impairment p of Fertility: y Alvimopan at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) was found to have no adverse effect on fertility and reproductive performance of male or female rats. 17 PATIENT COUNSELING INFORMATION 17.1 Recent Use of Opioids Patients should be informed that they must disclose long-term or intermittent opioid pain therapy, including any use of opioids in the week prior to receiving ENTEREG. They should understand that recent use of opioids may make them more susceptible to adverse reactions to ENTEREG, primarily those limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). 17.2 Hospital Use Only ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) Program under a REMS that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. Patients should be informed that ENTEREG is for hospital use only for no more than 7 days after their bowel resection surgery. 17.3 Most Common Side Effect Patients should be informed that the most common side effect with ENTEREG in patients undergoing surgeries that include bowel resection is dyspepsia.

60 40 20 0

Low ambiguity

High ambiguity

Pain intensity 100 80

VAS Rating

The following is a brief summary only; see full prescribing information for complete product information.

7.3

60 40 20 0

Low ambiguity

High ambiguity

Parenteral opioid in ED 100 80

VAS Rating

ENTEREG® (alvimopan) Capsules

60 40 20 0

Low ambiguity

High ambiguity

Oral opioid in ED 100 80

VAS Rating

60 40 20 0

Low ambiguity

High ambiguity

Oral opioid Rx at discharge

Figures. Effect of race on physician pain rating and opioid prescribing. ED, emergency department; VAS, visual analog scale

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

In the News

Preoperative Routines Reduce Post-Op Risks in Obese Patients

YOU can reduce post-surgical complications by

32% 1

B Y A JAI R AJ

edicated protocols for obese patients undergoing abdominal surgery can greatly reduce their risk for complications after the procedure, researchers have found. Ensuring that patients are physically fit and knowledgeable about the procedure, combined with steps to minimize the risk for blood clots and other complications, might be key to preventing adverse outcomes and hastening recovery, the researchers said. “This gives us a good opportunity to have patients go through major surgery and still prevent the more frustrating complications of surgery, like developing a clot, or developing pneumonia after an operation,” said David Shaz, MD, a pulmonary intensivist at the James J. Peters VA Medical Center in New York City, where the retrospec-

also worked with the patients. Before surgery, doctors administered heparin and applied compression boots to prevent blood clots. In addition, 95 patients were given heparin on postoperative day 1. Continuous or bilevel positive airway pressure was applied to 30 patients on the first night postsurgery, to assist with sleep apnea. To prevent lung collapse, 70 patients were encouraged to walk more than 100 feet within five hours of undergoing surgery. On average, the patients were discharged 2.44 days after the procedure. No patients experienced blood clots or collapsed lungs, although a few contracted pneumonia or bronchitis. These results suggest that following dedicated protocols can lead to better patient outcomes, Dr. Shaz said. Patient preparedness is the key factor, he said. The protocols show promise not just for laparoscopic sleeve gastrectomy procedures, but other types of surgery as

in your moderate to high-risk patients.

A large body of evidence demonstrates that hemodynamic optimization through Perioperative Goal-Directed Therapy (PGDT), utilizing dynamic parameters which are informative in determining fluid responsiveness, has been shown to reduce post-surgical complications.1–4 randomized controlled trials and meta-analyses confirmed reduction of risk for AKI, anastomotic leaks, pneumonia, SSI and UTI.1–4

tive chart review was conducted. Dr. Shaz and his colleagues presented their findings at the 2014 annual meeting of the Society of Critical Care Medicine (abstract 603). The study included 105 morbidly obese patients (90 men) who had been referred for laparoscopic sleeve gastrectomy surgery by their primary care physicians. The average age of the patients was 51, and their average body mass index was 45 kg/m2. To qualify for the surgery, patients first had to undergo a fitness and nutrition regimen that lasted between six and 12 months, to ensure that the regimen did not aid significantly with weight loss. The surgeries were performed over a span of about three years, between January 2010 and June 2013. Once accepted for surgery, patients were required to comply with a strict exercise and dietary program, and were thoroughly educated about the procedure and its risks. Psychologists and psychiatrists

well, said Megan Anders, MD, assistant professor of anesthesiology at the University of Maryland Medical Center, in Baltimore. “In the prior literature there are mixed data on the relative rate of complications after bariatric surgery, with some authors noting that an apparent lower rate of [venous thromboembolism] in some studies, for example, may be due to use of stricter protocols in these populations,” Dr. Anders said. “The data from this abstract, although limited in sample size, would support that theory. “This report does a nice job of demonstrating the importance of diligently measuring the outcomes we believe we are impacting with targeted protocols,” she added. “Being able to demonstrate that their complication rate is low when using this protocol can help maintain enthusiasm among medical professionals.”

When evidence inspires action, Edwards Enhanced Surgical Recovery program is here to help you implement PGDT. Your vision for reducing post-surgical complications can be realized in a single procedure, or as part of a larger initiative like ERAS, Perioperative Surgical Home or a Quality Improvement Program.

Edwards.com/ESR1 References: 1. Grocott et al. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane systematic review. Br J Anaesth 2013 2. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth 2009; 103: 637–46 3. Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care 2011; 15: R154 4. Corcoran T et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratified Meta-Analysis. Anesthesia – Analgesia 2012 Edwards, Edwards Lifesciences, the stylized E logo, and Enhanced Surgical Recovery are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11710

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Finding Keys to Recovery After Colorectal Surgery B Y V ICTORIA S TERN

he goal of any perioperative protocol is to improve patient outcomes after surgery. In colorectal surgery, however, there is minimal evidence to support traditional perioperative practices, such as bowel preparation and fasting before surgery. In the mid-1990s, this gap in understanding prompted a group of surgeons,

led by Henrik Kehlet, MD, PhD, from Copenhagen, to begin implementing early recovery efforts. Following Dr. Kehlet’s work, a multinational group of surgeons and anesthesiologists began collaborating as the Enhanced Recovery after Surgery (ERAS) research group. The aim of ERAS is to systematically study patients’ physiologic responses to surgery and develop a multifaceted, evidence-based approach to patient care in colorectal surgery and other disciplines.

At the 22nd International Congress of the European Association for Endoscopic Surgery (EAES), Nader Francis, MBChB, PhD, and colleagues presented an up-to-date review of ERAS in colorectal surgery, pinpointing factors that may allow surgeons to enhance and ultimately predict patient outcomes (abstract O074). “There are many features that impact patient outcomes and we don’t necessarily know which are the most relevant to recovery,” said Dr. Francis, consultant

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Robotic vs. Lap Inguinal Hernia Repair: Why I Switched to Robotic TAPP from Lap TEP • Thomas J. Swope, MD

Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Individual surgical results may vary. For Important Safety Information, indications for use, risks, full cautions and warnings, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com. © 2014 Intuitive Surgical, Inc. All rights reserved. PN 1015044 Rev A 7/14

‘It could save hundreds of thousands of dollars a year and would require minimal to no extra costs for hospitals to realize.’ —Julie Thacker, MD colorectal surgeon at Yeovil District Hospital in Somerset, England. “Our ongoing research is working to uncover the key factors in perioperative care.” Although no standard ERAS protocol yet exists in colorectal surgery, most include formal patient education, eliminating bowel preparation and allowing clear fluids up to three hours before surgery. Intraoperatively, studies show that laparoscopic surgery, goal-directed fluid management, less operative time and reduced blood loss aid patient recovery ( S 2014;18:265-272). Postoperative(JSLS ly, the use of thoracic epidural analgesia, avoidance of nasogastric tubes, and early feeding, mobilization, discontinuation of IV fluid and removal of urethral catheters are important features as well (Ann ( Surg 2000;232:51-57). Despite the lack of consensus, a growing body of research shows that employing ERAS principles reduces hospital length of stay and complications in colorectal surgery (Ann ( Surg 2000;232:51-57; Br J Surg 2006;93:800809; Anesth Analgg 2014;118:1052-1061). For instance, in a 2014 study comparing outcomes in a traditional care (99 patients) and ERAS group (142 patients), Julie Thacker, MD, and her colleagues at Duke University Medical Center, Durham, N.C., found that patients following an enhanced recovery protocol had a significantly shorter length of stay (five vs. seven days; P<0.001), fewer urinary tract infections (13% vs. 24%; P P=0.03), reductions in duration of ileus and lower readmission rates (9.8% vs. 20.2%; P=0.02). P The Duke enhanced recovery protocol was also associated with lower medical costs, about $2,000 per patient or a 10% decrease in the costs of traditional care. “This reduction in cost is a huge bonus for patients and the health system,” said Dr. Thacker, assistant professor in the Department of Surgery. “It could save hundreds of thousands of dollars a year and would require minimal to no extra costs for hospitals to realize.” But, given the abundance of perioperative factors being studied and the complexity of different health systems, ERAS can be difficult to implement. In a 2012 study (Colorectal Diss 14:e727-e734), Dr. Francis and his colleagues retrospectively

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analyzed outcomes of 385 patients who underwent elective laparoscopic or open colorectal resection at Yeovil District Hospital between 2002 and 2009, and found that 31% of patients stayed more than one week (delayed discharge), and 41% deviated from the ERAS protocol. The authors concluded that failing to comply with ERAS one day after surgery was strongly associated with delayed discharge. In a recent analysis, Dr. Francis and his colleagues tried to determine what factors cause patients to deviate from an enhanced recovery protocol. After prospectively collecting data from 178 patients who had undergone open or laparoscopic colorectal surgery between January 2006 and December 2009, the surgeons found that of the 32% of patients who deviated from the program, the most common reasons cited were failure to mobilize after surgery (80.7%), continued use of IV fluids beyond 24 hours (59.7%), failure to resume an oral diet (45.6%) and inadequate pain control (10.5%). The adoption of ERAS across Europe and the United States has also seen varied success. In the United Kingdom, hospitals are encouraged to adopt enhanced recovery for colorectal surgery, and their payment

schemes are tied to protocol compliance. “Over the last 10 years, we’ve seen an amazing spread of ERAS,” Dr. Francis said. “The program now exists in every hospital in England.” But looking beyond the United Kingdom to the rest of Europe and the United States, ERAS is not taking hold as quickly. “National mandates, transparent audits and government-funded implementation efforts in the U.K. create a very different picture than surgeon and anesthesiologist-driven work in the U.S.,” said Dr. Thacker. “Trying to change a little bit about everything included in perioperative care in the U.S. is extraordinarily challenging.” Part of the difficulty is that each hospital in the United States has different capabilities and guidelines, which means the challenges to implementing an enhanced recovery protocol will vary by hospital, Dr. Thacker noted. Despite these complex barriers, Dr. Thacker has started to garner support from surgical societies throughout the United States. “The more interest we get at the society and health system level, the easier it will be to improve perioperative care.”

Valuable insight to help you guide volume administration. Clarity gives you the control to make more informed decisions. Edwards Lifesciences’ range of hemodynamic monitoring solutions provides key flow parameters shown to be more informative in determining fluid responsiveness than pressure-based parameters.1

Each may be used in Perioperative Goal-Directed Therapy (PGDT) to help ensure patients are consistently maintained in the optimal volume range. The Edwards Enhanced Surgical Recovery Program can help you implement PGDT today.

Know more. Know now. To see how you can individualize therapy under more conditions visit Edwards.com/ESRsolutions 1. Michard F, Biais M. Rational fluid management: dissecting facts from fiction. Br J Anaesth 2012 For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market, meet the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC, and bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, ClearSight, Enhanced Surgical Recovery Program, FloTrac, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11991

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Welcome to the October issue of The Surgeons’ Lounge. In this issue, we welcome our readers to respond to the case presented, and be featured as our next “guest expert”! Send your replies to me at szomsts@ccf.org before Nov. 10, 2014. Please do not forget to include your full name and affiliations to ensure you are listed correctly. Check out the special “Double Express” and see how the experts answer the following questions: “What is the smallest incisional hernia you will not perform laparoscopically?” and “Do you leave any drains after large openincisional hernia repair with prosthetic mesh?” Feedback from our readers is our greatest asset. Tell us how we’re doing! What do you want to see more of? Less of? What is the best part of Surgeons’ Lounge? What can we do even better? We look forward to your feedback! Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org

Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Question for Our Readers Amir Mehran, MD University Bariatrics, Thousand Oaks, Calif., and Ara Keshishian, MD, Central Valley Bariatrics, Verdugo Hills, Calif.

A 65-year-old man presented with a painful enlarging symptomatic umbilical hernia that he had for several years. He denied any obstructive gastrointestinal (GI) symptoms or coughing, urinary hesitancy or constipation. His past history was significant for obesity, hypertension, sleep apnea, gastroesophageal reflux disease, mild lower extremity edema and an open appendectomy. He did not use tobacco and took olmesartan and close to a dozen herbal and naturopathic supplements. Physical examination revealed a body mass index of 34 kg/m2, and a partially reducible umbilical hernia measuring roughly 5 cm in diameter. Mild skin “stretch”

discoloration was also noted without any obvious cellulitis. After a thorough discussion of his options, a decision was made to proceed with a laparoscopic repair with mesh due to his obesity and to avoid going through the discolored area. After a thorough medical evaluation, he underwent an uneventful laparoscopic umbilical hernia repair with a 15 x 20 cm Physiomesh (Ethicon End-Surgery). The patient had received a 900-mg IV preoperative dose of clindamycin (anaphylactic penicillin allergy) and the mesh had been soaked in antibioticlaced saline solution. Two 5-mm ports and a 12-mm port, all nonbladed, were placed along the left abdomen. The hernia contained omentum, which was dissected off using gentle traction and the Harmonic Scalpel (Ethicon Endo-Surgery). Using the Securestrap fixation device (Ethicon

Endo-Surgery), the umbilicus was everted by tacking the hernia sac inside the abdomen, thus giving the patient a normal looking umbilicus (“innie”). The mesh was inserted through the 12-mm port and did not come into contact with the skin at any point. It was secured with four preplaced Gore CV-0 transabdominal fixation sutures (W.L. Gore), as well as two rows of Securestrap tackers. Diagnostic laparoscopy at the end of the case did not reveal any intraabdominal injuries or bleeding. The Foley catheter, placed at the beginning of the case, was removed without sequelae. The patient tolerated the procedure well and was discharged the same day at his request, once he was able to tolerate fluids and void on his own. He was not discharged on any antibiotics. The patient did well for the next two weeks but then called about a lowgrade fever (100.1 F) associated with

Figure 1. Day of reoperative surgery. coughing, hoarseness and left lower abdominal pain near the left iliac crest. He denied any GI symptoms, pain or redness around the incisions. Due to the driving distance involved, he opted to see his primary care physician (PCP)

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Figure 2. Intraoperative picture of inferior aspect of mesh. first. His PCP performed routine laboratory tests and diagnosed him with an upper respiratory infection and possible laryngitis. The patient was seen in the surgical clinic five days later and was noted to have painless erythema around the umbilicus (Figure 1). His abdominal exam was otherwise unremarkable, including recurrence or seroma formation. On further questioning, however, the patient did complain of a new onset of urinary hesitancy and tenesmus. Because he had never undergone a colonoscopy or annual urologic exam, a rectal examination was performed revealing a large hard prostate and extreme discomfort. The erythema boundaries were marked and

Double

the patient was discharged on oral clindamycin. The patient’s PCP subsequently changed the antibiotics to nitrofurantoin because the lab work from five days before showed an Escherichia colii urinary tract infection with elevated serum white blood cell (WBC) count. Of note, the patient’s preoperative WBC count was normal and a urinalysis was not performed because he was asymptomatic. When the patient was contacted a few days later, he reported worsening fever, lethargy and no change in the abdominal wall erythema. He was advised to present to the emergency room where the examination revealed a temperature of 101.9 F, a pulse of 123 beats per minute, persistent

Expertess Expr

What is the smallest incisional hernia you will not perform laparoscopically?

David Edelman, MD: 2 cm, but it’s not the size, it’s the symptoms and whether it’s recurrent.

periumbilical erythema with warmth, but no abdominal distention or any tenderness to palpation. Laboratory work was significant for a WBC count of 24,000 with left shift and a urinalysis with positive leukocyte esterase, significant pyuria and moderate bacteria. A contrast abdominal computed tomography was performed, demonstrating a prominent prostate, bladder wall thickening and some nonspecific fluid around the mesh and hernia site. The patient was admitted to the hospital and upon consultation with infectious disease consultants, was placed on vancomycin, levofloxacin and metronidazole. The patient did not clinically improve over the next 24 hours and the erythema appeared to have worsened. He was taken to the operating room for a laparoscopic exploration and possible mesh removal. Intraoperatively, the superior aspect of the mesh was found to be clean with minor omental adhesions. The inferior aspect, however, had thicker adhesions with a pocket of fibrinous fluid (Figure 2). Using the Harmonic Scalpel, the mesh was fully excised and removed with an endobag. Gram stain of the mesh revealed no organisms with rare PMNs [polymorphonuclear leukocytes]. The patient made a very rapid recovery and was discharged from the hospital within 48 hours on oral antibiotics

Edward Felix, MD: Small umbilical or tiny midline congenital hernias. Incisional, usually laparoscopic.

pending outpatient evaluation and final mesh culture results, which remained negative. Final pathologic examination of the specimen showed adherent fibroadipose tissue with fibrosis, fibrin deposition, foreign body reaction and mostly chronic inflammation. In follow-up visits, the patient remains well and does not wish any further herniorrhaphy. Questions: • Is this case consistent with mesh allergy or mesh infection and what are alternative management options? • If this was an allergic reaction, is this the typical course and is this particular mesh (or any other mesh) known for this type of reaction? Is there any rationale for prescribing corticosteroids before reoperative surgery? • If this was due to a urinary tract infection, is it likely from a Foley or from prostatitis or both, and is this course normal (i.e., two weeks postoperatively? No pain and no microbes on path or cultures?)? • Should the urinalysis be checked on all patients, including asymptomatic men, and is there a role for continued antibiotics (IV or oral) after surgery?

Natan Zundel, MD: 3 cm

Michael Sarr, MD: 3 cm

you leave any drains after Q.Dolarge open-incisional hernia repair with prosthetic mesh? Edward Lin, MD: 3 cm

Yes Ronald A. Hinder, MD: 3 cm

Nataniel Soper, MD: 3 cm

Maher Abbas, MD: 2 cm, 3 cm or ggreater, consider laparoscopy, because ssometimes smaller defects can be sseen around the hernia site.

Edward H. Phillips, MD: I prefer oopen-incisional hernia repair except ssubxyphoid hernias. Usually the whole wound will eventually deteriorate and w rrecurrences are at the edge of limited rrepairs. So size doesn’t matter, but for sure any ventral incisional hernia I can repair under local monitored anesthesia care, I will do “open.”

Dan Herron, MD: 2 cm

Edward H. Phillips, MD Raul Rosenthal, MD Michael Sarr, MD Edward Felix, MD Nataniel Soper, MD David Edelman, MD

No Natan Zundel, MD Edward Lin, MD Daniel M. Herron, MD Maher Abbas, MD Ronald A. Hinder, MD

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Allvar Gullstrand: Surgeon, Nobel Prize Winner, Egoist B Y V ICTORIA S TERN

llvar Gullstrand, MD, PhD, was the second surgeon ever to be awarded the Nobel Prize for Medicine or Physiology. Interestingly, however, Dr. Gullstrand’s contributions to science and medicine had nothing to do with surgery. His life’s passion, and the pioneering work for which he received the ultimate prize, centered on how

light refracts in the eye to form visual images. “He was brilliant, and it remains quite a feat that his formulas and theories are still relevant over 100 years later,” said Sibylle Scholtz, PhD, a researcher at the International Vision Correction Research Centre in the Department of Ophthalmology, University of Heidelberg, Germany. Despite this, Dr. Gullstrand remains a complex figure, one who pushed the

boundaries of science at the same time that he stymied them. As his prominence grew, so did his ego. “He was stubborn and proud, and had a self-esteem surpassed by none,” said Berndt Ehinger, MD, professor emeritus in the Department of Ophthalmology, University of Lund, Sweden. “He was convinced that he was superior to everybody, and did not tolerate anything that challenged that.” Dr. Gullstrand’s arrogance was

Allvar Gullstrand, MD, PhD

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particularly apparent in his relationship with Albert Einstein. Dr. Gullstrand spent more than a decade trying to prevent Einstein from receiving the Nobel Prize in Physics for his theory of relativity. However, according to Robert Marc Friedman, PhD, professor of history of science at the University of Oslo, in Norway, Dr. Gullstrand’s attempts to refute Einstein’s theory only “revealed humiliating gaps in Gullstrand’s command of the physics as well as vehement prejudice in his evaluation.”

The Rise of Gullstrand Dr. Gullstrand’s desire to understand the physical properties of the world began as a young man. He was born on June 5, 1862, in Landskrona, Sweden, to Pehr Alfred Gullstrand, MD, a physician and former officer in the army, and Sofia Mathilda. After primary school, Dr. Gullstrand moved to Jönköping, Sweden, where he met an important mentor. One of his grammar school teachers, a former mathematics lecturer at the University in Lund, took notice of Dr. Gullstrand’s aptitude and encouraged him to pursue mathematics on his own. Dr. Gullstrand took this advice to heart. He buried himself in advanced concepts, and taught himself infinitesimal calculus and geometry (Documenta Ophthalmologica 1962;16:283-337). “Gullstrand handled this as easily as most people handle simple additions or subtractions,” Dr. Ehinger said. In 1880, when Dr. Gullstrand left home for Uppsala University, in Sweden, he hoped to focus on engineering, but his father persuaded him to follow in his footsteps and study medicine instead. From 1885 to 1888, Dr. Gullstrand attended medical school at Stockholm’s Royal Caroline Institute. In 1885, he married Signe Christina Breitholtz, and the couple had a daughter, Esther, who died of diphtheria at age 3 years. Although there is little mention of his family life, according to Daniel

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Albert, MD, professor of ophthalmic pathology at Harvard Medical School, Boston, Mrs. Gullstrand supported her husband wholeheartedly, and her “great ambition was to make her husband as comfortable as possible when he rested from his strenuous work” (Trends Neurosci 1980;3:IV-VI). During his studies, Dr. Gullstrand decided to specialize in ophthalmology because of its emphasis on mathematics, and spent a year studying in Vienna, the center of ophthalmology in the late 1800s. “The fact that he spent time in Vienna suggests that he was ambitious,” Dr. Scholtz said. “At the time, everyone who wanted to make a real career in medicine had to go to Vienna, especially for ophthalmology.” What set Dr. Gullstrand apart from his peers was his ability to recognize the true complexity of the eye. While studying physiology, Dr. Gullstrand identified flaws in the prevailing theory of astigmatism. He realized that the model of astigmatism, set forth by Jacques Charles François Sturm, was too simplistic and only applied in a very specific theoretical condition. Dr. Gullstrand observed a more nuanced picture. He saw that the curvature of the lens and pupil is not static, but changes as the eye focuses on an image at different distances. These adjustments in shape affect how the eye refracts light and how an image ultimately forms in the eye, a process called accommodation. Additionally, he discovered that the lens is not homogeneous, as Dr. Sturm had assumed; instead, it contains several media with different refractive indices, all of which need to be determined to understand how light beams refract after penetrating the surface of the eye. Building on these key insights, Dr. Gullstrand was able to resolve the errors in Dr. Sturm’s system. He developed his own theory of astigmatism and derived a fundamental equation for optical image formation, which he described in his 1890 doctoral thesis “Contribution to the theory of astigmatism.” Perhaps even more incredible, Dr. Gullstrand did not have a tutor to mentor him during his pioneering thesis work. Dr. Gullstrand’s impressive thesis research helped catapult his career. He worked as an ophthalmic practitioner in Stockholm, and in 1892, he became the clinic director and lecturer of ophthalmology at the Karolinska Institutet, in Stockholm. By 1894, he was appointed the first professor of ophthalmology at Uppsala University, a position created specially for him so he could continue his work. He held this post for the next 20 years. Working off the momentum from his

thesis, Dr. Gullstrand dedicated himself to generating a comprehensive theory to explain refraction of light in the eye. Working toward this goal, he refused to take holidays and devoted four hours every night to his personal scientific explorations. Dr. Gullstrand expressed his complete devotion to ophthalmology, writing, “A professor whose hands do not shake by the end of the academic year has not performed his duties properly.” By 1900, he had published a complete proof of this theory on astigmatism in three works, for which he

received awards from the Swedish Royal Academy of Sciences and Swedish Medical Association. By 1911, he became the first person to describe the optical laws of imaging in the eye, creating a detailed model of the human eye called the Gullstrand eye, and deriving a formula to calculate optical image formation, the Gullstrand formula. Both the Gullstrand eye and formula are still considered “gold standard” today, Dr. Scholtz said. Dr. Gullstrand not only advanced understanding of how the eye works, he also invented new practical and

diagnostic devices for patients and practitioners, including corrective lenses for patients after cataract surgery, a reflexfree ophthalmoscope designed to examine the eye without light reflecting back at the viewer, and perhaps most famously, the slit lamp, which allowed the most detailed look into the eye to date (Figure). Dr. Gullstrand first demonstrated his slit lamp at the Swedish Ophthalmological Society in 1911, the same year he received the Nobel Prize in Medicine or Physiology for his contributions to optics. see NOBEL PRIZE page 28

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jcontinued from page 27 Before this, microscopes were woefully inadequate, providing dim, poorly focused light. Dr. Gullstrand thought he could improve the power of the microscope by using a narrow bundle of converging light beams, or a slit. In 1910, he proposed this idea to Moritz von Rohr, an engineer at a German company called Zeiss Optical Works. Dr. von Rohr’s team proceeded to develop the slit lamp. The original design consisted of a filament bulb, system of lenses,

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

and slit that created a high-intensity and more sharply focused beam of light. The slit lamp enabled viewers to closely examine the surface of the front of the eye, especially the cornea, and allowed for improved diagnostics. When combined with a binocular microscope, “it became the basis of the instrument that is still used in every ophthalmologist’s office today,” Dr. Scholtz said.

Double Nobel Candidate In October 1911, Dr. Gullstrand was awarded the Nobel Prize in Medicine or Physiology for his work on “the

diffraction of light by lenses applied to one eye.” In the speech honoring Dr. Gullstrand’s achievement, K.A.H. Mörner, rector of the Royal Caroline Institute, wrote: “He has transformed the theory of optical image-formation and has formulated the fundamental equation from which are derived the hitherto unknown laws of optical image-formation.” Notably, Dr. Gullstrand is the only person to date to both receive and decline a Nobel Prize. Dr. Gullstrand, who had also been appointed a member of the Nobel Prize committee for

physics, was nominated for the award in physics in 1910, and was set to win it in 1911. However, he decided to accept the award in physiology or medicine instead of in physics. Given the obvious conflict with Dr. Gullstrand’s nomination for the prize in physics and his appointment to the Nobel Prize committee, “we do not know if Gullstrand excused himself during the discussions,” wrote James Ravin, MD, Department of Surgery, Section of Ophthalmology, Medical College of Ohio, in Toledo ((Arch Ophthalmoll 1999;117:670-672). “What transpired during the committee meetings in 1911 has never been made public.”

Einstein’s Nobel Journey At Uppsala University, Dr. Gullstrand’s opinion reigned supreme among his colleagues and students. “He announced that questions were welcome at his lectures, but he also proudly stated that discussions were unnecessary, because he always gave a correct and fully satisfying answer,” Dr. Ehinger noted. Carl Wilhelm Oseen, PhD, professor of theoretical physics at Uppsala University, echoed these sentiments, in Dr. Gullstrand’s obituary: His position in the faculty and senate in Uppsala became a legend … There was never the least inconsistency which could give rise to criticism or discussion… The medical members of the senate could testify that this unbroken unity was the work of Gullstrand … If every case had initiated a discussion, the session would be unbearably long. The modus vivendi that developed under these circumstances was characterized by the condition that only one person spoke and that person was Gullstrand. In this situation Gullstrand could mark the end of a session by thanking the other members of the senate that they had not taken up the senate’s time by speaking … Dr. Gullstrand appeared to exert a similar influence while serving on the Nobel committee in physics from 1911 to 1929. He used his sway to prevent Albert Einstein from receiving a Nobel Prize in Physics for his theory of relativity, despite the fact that Einstein was nominated for the physics prize every year from 1910 to 1922, except 1911 and 1915. In fact, Dr. Gullstrand once

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(Europhysics News 2005;36:129134). To this end, Dr. Oseen emphasized, and perhaps exaggerated, the link between Bohr and Einstein’s work—that Einstein’s photoelectric effect explained Bohr’s work on the structure of the atom—and thus both deserved the prize. Despite Dr. Oseen’s efforts, Dr. Gullstrand successfully postponed the 1921 Nobel Prize in Physics from being awarded to anyone. In 1922, however, Dr. Oseen joined the

The slit lamp, developed by Dr. Gullstrand, allowed for a more detailed look into the eye.

remarked that “Einstein must never receive the Nobel prize, even if the entire world demands it” (Europhysics News 2005;36:129-134). Many physicists of the day felt that Einstein’s theory of relativity represented a threat to physics. Dr. Gullstrand made it his mission to disprove Einstein’s theory of relativity and block him from ever being awarded the prize. One of Dr. Gullstrand’s biggest objections to Einstein’s theory was that he believed the equations for the movements of bodies and of the perihelion of Mercury to be flawed. However, Dr. Gullstrand was never able to prove Einstein wrong. “His extraordinary arrogance led him to believe he was qualified to sit in judgment of works in physics that he did not all master,” Dr. Friedman wrote in an email to General Surgery News. “He did not understand theoretical physics as it was developing in the German-speaking world, and among other highly faulty evaluations, he simply did not understand nor want to understand Einstein’s special and general theories of relativity.” Eventually, Dr. Oseen devised a loophole through which Einstein could finally receive the Nobel Prize. In 1921, Dr. Oseen nominated Einstein for his discovery of the photoelectric effect, which he said went beyond a simple theory, calling it a “law” of nature. Dr. Oseen had another objective in pushing Einstein’s nomination: He also wanted to see Niels Bohr receive a Nobel Prize for his new quantum theory of the atom, which Dr. Oseen felt was “the most beautiful of all the beautiful”

Nobel committee, and that year both Einstein and Bohr were awarded the physics prize. Einstein received the Nobel reserved for 1921 for his “discovery of the law of the photoelectric effect,” but never won one for his most notable accomplishment, the theory of relativity.

Gullstrand’s Legacy Nearly 85 years after Dr. Gullstrand’s death in 1930, ophthalmologists still consider his work to be critical to the understanding of the human eye. “I am convinced that Gullstrand reached

his achievements thanks to an unusual drive for perfection in measurements and observations, and an unusual ability to comprehend complex conditions,” Dr. Ehinger said. Although revered by many as a visionary, he is also criticized for his obstinacy when it came to Einstein’s theories. Perhaps the dogmatism, ego and drive that made him so successful in his own research are the qualities that blinded him to the virtues of Einstein’s work. As Dr. Oseen judiciously characterized it, “[Dr. Gullstrand] was a man who made himself felt wherever he was.”

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will maintain antimicrobial effectiveness for at least 48 hours.4,5 References: 1. Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efﬁcacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009;91(8):1949–1953. 2. Ostrander RV, Botte MJ, Brage ME. Efﬁcacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005;87(5):980–985. 3. Adler MT, Brigger KR, Bishop KD, Mastrobattista JM. Comparison of bactericidal properties of alcohol-based chlorhexidine versus povidone-iodine prior to amniocentesis. Am J Perinatol. 2012;29(6):455–458. Epub 2012 Mar 7. 4. Denton GW. Chlorhexidine. In: Block SS. Disinfection, Sterilization, and Preservation. 5th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:321–336. 5. Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005;28(3):194–207.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Postoperative Surgical Ward Pneumonia Cut by More Than 40% B Y P AUL B UFANO

postoperative pneumonia prevention program for patients in the surgical ward nearly halved the incidence of the condition, California researchers have found. The program, at the VA Palo Alto Health Care System, emphasized ongoing education for nurses, pneumonia prevention, coughing and deep-breathing

exercises with an incentive spirometer, twice-daily oral hygiene with chlorhexidine, walking and sitting up to eat. The study included patients who were not on a mechanical ventilator from 2008 to 2012. During this time, there were 18 cases of postoperative pneumonia among 4,099 at-risk patients, for a case rate of 0.44%. That marked a 44% decrease from the hospital’s preintervention rate of 0.78%, according to the researchers. Pneumonia rates in all years

One concern about the research was that changes in patient care or surgical technique that could have altered the incidence of postoperative pneumonia were not evaluated.

were lower than the preintervention rate (0.25%, 0.50%, 0.58%, 0.68% and 0.13% in 2008 to 2012, respectively). “The standardized pneumonia prevention program achieved substantial and sustained reduction in postoperative pneumonia incidence on our surgical ward; its wider adoption could improve postoperative outcomes and reduce overall health care costs,” wrote the authors, who published their findings in JAMA Surgery (2014 Jul 23 [Epub ahead of print]). Although encouraging, these findings should be interpreted with caution, said Catherine Lewis, MD, a specialist in surgical critical care at the University of California, Los Angeles.

“Although the number of ward cases decreased from 13 to three, the number of non– ventilator-associated pneumonia ICU cases increased from four to 17, and therefore, the reported decrease could be due to redistribution in the location of patients,” Dr. Lewis wrote in an invited commentary to the paper. “[Another] concern is that the authors did not evaluate changes in patient care or surgical technique that could have altered the incidence of postoperative pneumonia.” However, despite these concerns, she added, “The authors should be commended for the development and implementation of a quality improvement measure aimed at decreasing the rate of postoperative pneumonia in a Veterans Affairs population.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Bundled Pay for Colonoscopy Inevitable—But Maybe Not a Bad Thing B Y C AROLINE H ELWICK CHICAGO—As the economics of medicine continues its move toward bundled payments, is it time gastroenterologists embrace the shift? At least one expert believes the moment has come. John Allen, MD, MBA, president of the American Gastroenterological Association Institute, said an increasingly unfavorable climate for reimbursement for colonoscopy means gastroenterologists (GIs) must begin to consider bundled payments in their negotiations with payors, hospitals and health systems. “For a number of years, we have been demonstrating the quality and value of colonoscopy in terms of cancer reduction, but now we are facing unprecedented pressures in terms of cost. We are getting to a tipping point where the unit payment is going to be below the unit cost for many of us,” said Dr. Allen, who also is professor of medicine and clinical chief of digestive disease at Yale University School of Medicine, in New Haven, Conn. “If we want to preserve this important lifesaving tool, we are going to have to start thinking about different ways of packaging it.” The expense of colonoscopy has become a contentious issue, as studies show tremendous variation in cost among different providers. Virtually every large commercial payor now has a mechanism by which beneficiaries can examine their benefits and providers’ fees. “The entry point for these programs is supposedly quality, but this threshold is relatively low,” Dr. Allen said. “Patients are really choosing based on price and site of service.”

Both Medicare and private payors are developing infrastructures for bundling payments for colonoscopy. If GIs and their societies do not define the “risk corridors” within these bundles, payors will do that for them, Dr. Allen said. Risk corridor describes the elements of a bundle, which can be narrow or wide depending on the amount of care. For example, Dr. Allen said, if GIs include post-polypectomy bleeding in their care bundle, the risk corridor would be broader

than one that stopped when patients were discharged from the endoscopy unit. “The wider the corridor, the greater the risk to the practice—but also the greater the reimbursement per procedure,” Dr. Allen explained. “A highly technical practice should be able to define the number of events in a particular component and then be able to ‘price’ that. Just like with stock or bond investments, the greater the risk, the greater the potential return—or loss.”

What a Colonoscopy Bundle Looks Like The Centers for Medicare and Medicaid Services (CMS) is emphasizing two areas for the care of gastrointestinal disease: bundled payments for defined episodes and the specialty-based medical home. For the bundled payment model, the provider’s payment is determined by the see BUNDLE page 32

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

BUNDLE

jcontinued from page 31

expected cost of the bundlle for giving effective and efficient care.. Within this model, screening colonoscopy is “high on the priority list,” Dr. Allen said, as it is easy to define, has pred dictable costs and complications, and yieelds itself to risk stratification. Some experts have pro-posed a colonoscopy bundle that looks like this: • Pre-procedure (three days): assessment for appropriateness, patient instruction and prep • Procedure (one day): professional fees, sedaation, equipment and pathology • Post-procedure warran nty (seven to 14 days): ressult reporting, complicatioons, repeat procedure for poor prep, and imaging for incomplete procedure • Tie-in with granular quality metrics. An American Gastroenterological Association task force recently proposed a bundleed payment framework for colonoscopy screening and surveillance based on data from Humana and MccKesson. It includes a surgical warrantyy and allows individual practices to an nalyze their costs, processes and comp plications, to negotiate for bundled paym ment, and to choose their own risk corriidors. “We wanted to define an n infrastructure of a bundle that we believe lieve is medically definable and fair,” Dr. Allen said. Gastroenterologists should not confuse bundled payments with reference pricing, another alternative payment model. With reference pricing, a set price exists for a specific service above which an employer will not pay, thus placing the member at full risk for this excess cost. A bundled payment, also known as episode-based payment, involves a single payment to providers or facilities, or both, for all services to treat a given condition or to provide a given service, such as colonoscopy. The provider is at risk for costs above the bundle, including potentially preventable complications. This is the model being employed by Minnesota Gastroenterology for colonoscopy. “These are important distinctions as you start being approved by ACOs [accountable care organizations] or managed care organizations,” Dr. Allen said.

‘We are getting to a tipping point where the unit payment is going to be below the unit cost for many of us. If we want to preserve this important lifesaving tool, we are going to have to start thinking about different ways of packaging it.’ —John Allen, MD, MBA

Coming Soon, to an Employer Near You A notable example of reference pricing is the program at Safeway in the San Francisco area. The grocery chain is self-insured and can draw from its own claims and financial databases. Safeway sets its reference price for a colonoscopy at $1,250, a fee that is lower than those charged by the vast majority of the 40 or so area colonoscopists. Employees can choose more expensive providers, but it comes out of their pocket, whereas anything below $1,250 is fully covered. Similarly, CalPERS, the nation’s second largest health care purchaser, set a reference pricing plan for joint replacement in 2011. The move triggered a market shift that reduced fees for the procedure at every facility in the area. CalPERS now is considering a combination of reference pricing and bundled payments, which will include some risk adjustment but also will increase provider risk, which Dr. Allen sees as an

emerging trend. The most startling example of bundled payments—labeled by Dr. Allen as “bundled payment on steroids”—is happening with Wal-Mart, which is offering free cardiac, spine and transplant surgery for employees who elect to be treated at one of six nationally regarded centers with which Wal-Mart contracts. “Patients have no out-of-pocket costs and no travel expenses, or they can choose a different hospital and all their copays and deductibles kick in,” Dr. Allen said. These programs clearly save the insurers money and they clearly shift the market to the lower-cost providers. “They also commoditize what we do, and that’s the danger,” he added.

Reasons To Consider Bundled Payment in Your Practice Although market forces may be the stick, Dr. Allen said there are some

carrots that make a colonoscop colonoscopy bundle worthwhile. For st starters, impllementing one could offer a p practice a m marketing advantage. “If you are the firrst kid on the block, you will demonstrate to payors or ACOs that you underrstand the emerging payment models,” he said. Bundled paymen nts also aree a hedge against falling fe fee-for-serviice rates. They provide a sstrong argu ument for maintaining the in-office Starrk exemption—which allow ws for the in-house provision of anesth hesiology an nd pathology services—and they allow a practice to control processees in ways that may not have been posssible in a feee-for-service environment, with opp portunities for innovation. T They also move the conversation to value and q quality. “In other w words, give m me a bundle, and I willl provide quality,” he said. “That ’s a strong argument that we neeed to lead w with. With some innoovation, I think we can thrivee in the AC CO world that is com ming.” John V Vargo, MD D, MPH, chair of gastroentero g ology and hepatologyy at Clevelaand Clinic, in Ohio, said he haas “sniffed around thee country”” to see whether sedation and patthology— two keyy services in coloonoscopy—are being included iin bundled p payments, and has fou und that “forr the most part, they are..” Dr. Vargo cauttioned that the inclusion of sedation iss a complexx calculus, because there are m many variablles to consider: primarily, an nesthesiologgist- versus gastroenterologgist-directed d sedation and severity adjustm adjustments, ments whic which include sedation requirements; American Society of Anesthesiologists classification; presence of obstructive sleep apnea; and polypharmacy. “I expect that we are going to see these bundles become more universal, and that variations of bundled parameters will standardize,” Dr. Vargo said. “They may undergo regionalization at first, but ultimately we will see more of a homogenized nationally based product. And once these things get benchmarked, we are going to see further diminution in what we are getting paid.” Dr. Allen reported financial relationships with gMed; consulting for Myriad, Olympus and Pentax; and participation in advisory committees or review panels for Ethicon EndoSurgery. Dr. Vargo disclosed a financial relationship with Cook Medical, and participation in advisory committees or review panels for Boston Scientific, Ethicon Inc., and GEye Cue Ltd.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Transoral Fundoplication Effective for GERD Not Controlled With PPIs B Y T ED B OSWORTH CHICAGO—One year after treatment, transoral fundoplication appears to provide superior relief of regurgitation and atypical symptoms associated with persistent reflux compared with high-dose drug therapy, new research shows. The 12-month crossover study found that patients with chronic gastroesophageal reflux disease (GERD) were far more likely to be free of symptoms if they underwent transoral fundoplication with the EsophyX2 device (EndoGastric Solutions) than if they remained on high doses of proton pump inhibitors (PPIs). At 12 months, 77% had achieved global elimination of regurgitation and atypical symptoms, and 82% were off PPIs. At a six-month interval, before a control group on high-dose PPIs was allowed to cross over to fundoplication, only 5% reported global elimination of symptoms. Based on these results, “transoral fundoplication is capable of dramatically eliminating GERD symptoms in appropriately selected patients with incomplete symptom control on high doses of PPIs,” said Karim S. Trad, MD, of the George

Washington University School of Medicine and Health Sciences, in Washington, D.C. Dr. Trad, who presented the results at 2014 Digestive Disease Week (DDW), emphasized that the relatively long-term results suggest that the benefit of GERD repair with this device is durable (abstract 724). A variety of devices for improving the barrier function of the lower esophageal sphincter have been developed over the past 40 years. Success has been uneven, however, particularly with longterm follow-up. The potential advantage of a transoral device approach over laparoscopic surgery is more rapid recovery and reduced risk for complications from anesthesia or infection. The EsophyX2 is equipped with a cartridge to deploy fasteners, and therefore is sutureless. The new study, conducted at seven centers in the United States, included patients with persistent symptoms on high-dose PPIs, a hiatal hernia of 2 cm or smaller, and increased esophageal acid exposure. Patients were randomized to transoral fundoplication or high-dose PPI therapy in a 2-to-1 ratio. With three patients lost to follow-up, there were 39 evaluable patients in the fundoplication

group and 21 patients who were treated initially with PPIs. At six months, all of those assigned to PPIs elected to cross over to transoral fundoplication. Of the 19 fundoplication patients with esophagitis at study entry, all were healed at the end of 12 months. Of the control group, 38% had healed on PPIs at six months, and 75% were healed six months after crossing over to fundoplication. At the start of the study, almost 75% of patients complained of regurgitation while on PPIs (and 90% when off PPIs). At the end of 12 months, only 10% of those randomized to fundoplication had complaints of regurgitation when off PPIs. At entry, the prevalence of such atypical symptoms as hoarseness, throat clearing and cough ranged from less than 60% to nearly 80% in the absence of PPIs. At 12 months, none of these symptoms was observed in more than 10% of patients off PPIs. Although the device is attractive for patients who are not responding to PPIs, who wish to reduce reliance on daily medical therapy, or who are concerned about the potential side effects of PPIs such as impaired nutrient absorption, evidence of efficacy is encouraging. It is even more

encouraging in a population with atypical symptoms, because they have long been challenging to treat and typically respond poorly to PPIs. For a chronic disease like GERD, documentation of benefit over even longer periods of follow-up will provide additional reassurance. Lars Lundell, MD, professor of surgery at Karolinska Institutet, in Stockholm, called the data “promising.” Previous studies of GERD, including many trials he has led, suggest that five-year data are required to confirm a durable response from surgical therapies, Dr. Lundell said. Still, he called the new study as “well designed,” and said the findings support including transoral fundoplication in the mix of therapeutic alternatives in GERD. “In my opinion, these observations are pivotal, and would form a robust platform and background for a shift in the current and future therapeutic algorithms for chronic GERD,” Dr. Lundell said. He indicated that the extended follow-up will better show where it fits in the context of other options. Dr. Trad disclosed a financial relationship with EndoGastricSolutions, which sponsored the study.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

Cryoablation Obviates Need for Surgery in Selected Patients B Y M ONICA J. S MITH LAS VEGAS—For a selected group of women with early-stage invasive ductal cancer (IDC), cryoablation appears to be so effective that they may avoid the operating room, according to research presented at the 2014 American Society of Breast Surgeons annual meeting. Lead author Rache Simmons, MD, chief of breast surgery, NewYork-Presbyterian/Weill Cornell Medical College, New York City, and colleagues from 19 different centers conducted cryoablation procedures on 86 women with unifocal IDC 2 cm or smaller. The approximately 20-minute procedure consisted of inserting an ultrasoundguided cryoprobe to the targeted lesion, with a freeze/thaw cycle of 6-10-6 minutes or 8-10-8 minutes. After ablation, the tumors were removed for pathologic confirmation of the treatment’s success. “We were looking for the success of the ablation, which we defined in two ways,” Dr. Simmons said. One definition was the lack of residual infiltrating cancer or ductal carcinoma in situ (DCIS), and the second was the lack of residual invasive cancers; the procedure would still be considered a success if the patient had DCIS. By the first definition, cryoablation was successful in 60 of the 87 patients (69%); by the second definition, it was successful in 70 (81%). “Then we broke the patients down by tumor size, which showed to be quite important,” Dr. Simmons said. The procedure was successful, with no invasive or in situ disease, in 63% of patients with tumors 1 cm or larger. But patients with tumors smaller than 1 cm had 94% ablation, which was considered remarkable, and was statistically significant (P=0.018). P A secondary objective was to evaluate the negative predictive value of postablation magnetic resonance imaging (MRI). “The reason we designed the study this way is that we didn’t expect to have 100% success, and we were hoping that MRI after ablation would be able to tell us how successful we were,” Dr. Simmons said. If so, “in a future nonresection trial, [MRI] could be deemed a surrogate for pathology so we would know if these patients have residual disease.” The MRI findings turned out to be consistent with the subsequent pathology reports in 86% of the patients who were negative for IDC and 75% of those who were negative for both IDC and DCIS, suggesting that MRI may indeed be able to predict pathology findings. Looking at the overall data, complete ablation was attained in 69% of the patients, and when success was defined as

complete ablation or residual disease detectable on MRI, the procedure was considered successful in 76% of the cases. “But what’s really important was when we broke this down by size we found that 94% of all tumors less than 1 cm had complete ablation. We also considered it a success if we saw the residual tumor on MRI, we had 100% success in those less than 1 cm,” Dr. Simmons said. “From my standpoint as a surgeon, I think it’s incredible that we’ve gone from

radical mastectomies, which were still being done occasionally when I was a medical student, to the promise of nonsurgical therapy for selected patients with breast cancer,” said Deanna J. Attai, MD, assistant clinical professor, Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, who was an investigator on the study. “This important study helps advance nonsurgical tumor ablation as an important option for women with small

ultrasound-visible breast cancers,” said Sheldon Marc Feldman, MD, FACS, chief, Division of Breast Surgery, , Columbia University College of Physicians and Surgeons, New York City. “I anticipate that with improvements in ablation technology and breast imaging that breast cancer tumor ablation will have an important role in patient care,” he added. “Patients are very eager to pursue ablation as an alternative to open surgery.”

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Strattice™ Tissue Matrix is clinically differentiated from other repair types in Complex AWR: • Can decrease downstream complications 5-fold in Complex AWR patients, and costs by 2-fold1 • Studied in more than 1,100 Complex AWR patients in 50 peer-reviewed articles 4 • <1% incidence of explantation reported in all peer-reviewed articles • Provides for a long-term repair4 1 LifeCell data on ﬁle based on a longitudinal analysis of private and public insurance claims from the Truven MarketScan® Database. Patients were followed from their initial procedure in 2007 for 18 months. (n=740). 2 Reynolds D, Davenport DL, Korosec RL, Roth JS. Financial implications of ventral hernia repair: a hospital cost analysis. J Gastrointest Surg.2013 Jan;17(1):159-66. 3 Poulose BK, Beck WC, Phillips SE, et al. The Chosen Few: Disproportionate Resource Use in Ventral Hernia Repair. Am Surg. 2013 Aug; 79(8):815-8.. 4 Searches performed on PubMed, Google, Google Scholar and ScienceDirect® in September 2013. Each study was considered independent during calculation. Studies may contain overlapping patient populations.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

The Prime Directive B Y S TEVEN S. K RON , MD

s anyone with a computer knows, before downloading a new program, you must indicate agreement with the Terms of Service (TOS), a tedious multipage scroll. By checking a box at the bottom of the page, you acknowledge that you have read and accept the TOS. Those crafted

by the really expensive lawyers have two check boxes—the first indicating that you agree with and accept the TOS, the other that you indeed have read the words to which you assent. Yeah right! Does anyone without a certifiable DSM-5 [Diagnostic and Statistical Manual] l disorder go through the ponderous legalese before checking off the box that says he or she has done

so? Furthermore, have there ever been negative consequences to such gross dishonesty? I doubt it. Which brings us to the written consent form that I’m confident we all obtain before administering anesthesia. Naturally, obtaining consent and obtaining a consent form are different animals entirely. Although few if any anesthesia lawsuits hinge exclusively on the lack of a consent form, the absence of one may hurt a defendant accused

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of other misbehavior. Should a lawsuit arise for an unrelated cause, those smart, really expensive lawyers certainly will use a poorly written consent to raise doubts about the anesthesiologist’s professionalism or concern for the patient. The anesthesia consent form has come a long way since my residency. Back then, it simply did not exist. Of course, we discussed anesthesia with patients during the preoperative visit. But because the surgical consent included a line that anesthesia would be administered, a separate written consent for the receipt of anesthesia was deemed unnecessary. The surgeon or anesthesiologist pretty much dictated the type of anesthesia, so the conversation tended to be one-sided. Entering private practice, I soon learned that patients’ desires mattered. If my plan conflicted with their preconception, I would need to convince them of the benefits of my approach. Yet I did not need their signature. After a decade or so, in response to some outside review, we decided to add a line signed by the anesthesiologist testifying to the fact that he or she discussed anesthesia, possible complications and alternatives with the patient. There was still no requirement for the patient to sign. The next incarnation added a requirement for the patient’s signature. This was a bit of an adjustment for those of us who were not sure how to discuss complications. Conventional medicolegal wisdom says that you need to mention common but minor and rare but catastrophic ones. So, do you tell them that they may get a little sore throat, a bit of nausea and oh, by the way, you might die (please sign at the X)? Our most recent consent form is by far the most thorough I have ever seen and has been made the standard for all

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

‘Words! Words! Words! I’m so sick of words.’ —Eliza Doolittle, My Fair Lady the members of the mega–hospital conglomerate to which we belong. It is similar to but even more complete than the form on the website of the American Society of Anesthesiologists and covers every possible issue that could arise. Of the hundreds of patients I have asked to sign this document, none— not one—has hesitated. Unfortunately, the problem I have consistently encountered is, despite a willingness to sign, their near 100% unwillingness to read that to which they are attesting! Some of the reluctance is no doubt due to the same lack of interest I have for reading the TOS discussed above: an understanding that these are lawyer-generated documents designed to, as more than one patient has accurately put it, “cover your ass”! My response is to agree, again offer to tell them the risks, and if and when they refuse, make a few lawyer jokes and off to sleep. Often, there is the complaint that the document is too long and wordy and written in an illegibly small font. Perhaps most important, by the time they have gotten to me, they have signed multiple forms—consents, releases of information, HIPAA forms and assignments of benefits and are, like Eliza Doolittle, just so sick of words. In my dealings with genuinely sick patients having major procedures, I have found that they and their families generally do seem to appreciate the potential hazards of anesthesia and a signature at the bottom of the page is a true acknowledgment of that.

Ironically, it is the healthier and particularly the morbidly obese patients with sleep apnea who are having moderate sedation for minor procedures, such as endoscopies, who seem less willing to understand risk. Explaining to these folks that propofol is a great drug that will quickly sedate them and allow for a rapid and nausea-free emergence, but may cause apnea or an obstructed airway, can be tricky. It also violates the prime directive: Don’t scare the customer.

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In the News HERNIA ROBOT jcontinued from page 1

after robotic ventral hernia repair. Proponents of this approach say patients are less likely to have chronic pain because surgeons can perform the repair without use of transfascial sutures or mesh fixation. “The thing that drew me to it is perhaps there may be some value in the robot over a traditional laparoscopic ventral hernia repair because you can sew the mesh in,” Dr. LeBlanc said. “You can do most of the dissection

A-0814014

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

robotically and then you can sew the mesh in. It eliminates the need for transfascial sutures. It also eliminates the need for mesh-fixation devices.” After attending several presentations on robotic hernia surgery, Dr. LeBlanc began to train on the robot that his hospital had purchased several years earlier. By late this summer, he completed more than 15 robotic hernia repairs (both ventral and inguinal) and plans to do more. The robotic procedures require more time, although Dr. LeBlanc expects procedure length will drop as he gains more experience.

‘I’m able to replicate the operation that we do open and place the mesh in the retromuscular position. I’m still able to do a myofascial release or component separation. I’m able to reconstruct the abdominal wall, both above and below the mesh, leaving it hidden from the viscera.’ —Alfredo M. Carbonell, DO He does not have extensive follow-up or the number of patients needed to draw any conclusions about long-term outcomes. But in the short term, he feels that

his patients experience less pain n. “The problem is that there has not been much data. I tried to com me up with some data to support the sw witch, but unless there’s been something published very recently, there’s very littlee,” said Dr. LeBlanc, who is organizing a randomized, prospective trial to compaare laparoscopic and robotic hernia repaiir. Even without data, more hernia surgeons are exploring the robotic option for repair. Intuitive Surgical, which h designs, manufactures and markets da Vinci Surgical Systems, did not providee numbers b when asked about surgeons performing hernia repairs with the robot. However, a spokesperson for the company said that last year’s overall growth of da Vinci surgery “was driven by general surgeons, many of whom perform hernia repair.” “Based on procedure run rates exiting 2013, general surgery is now the second largest and fastest growing U.S. specialty of Intuitive Surgical,” said Hasan Ertas, director of marketing, general surgery at Intuitive Surgical. But both Intuitive and surgeons acknowledge that the data to justify an uptick in robotic hernia repair do not yet exist. “To date, there are no comparative published peer-reviewed studies on robotic-assisted hernia repair outcomes,” according to the statement from Intuitive. Surgeons who use the robot said they believe it is advantageous for patients. In Greenville, S.C., Alfredo M. Carbonell, DO, associate professor of surgery and co-director of the Hernia Center, Greenville Health System, has been using the robot for hernia repairs and other foregut cases for almost two years. He became interested in robotic hernia repairs after seeing a Brazilian surgeon present his experience with robotic Rives-Stoppa retromuscular incisional hernia repairs. Dr. Carbonell adopted the approach, using the robot to replicate an open Rives-Stoppa retromuscular incisional hernia repair. He argued that the procedure combines the best of the laparoscopic and open approaches: The laparoscopic approach has a low wound infection rate but it is offset by the need for an intraperitoneal mesh and a higher risk for pain, whereas the open procedure is associated with less pain but a much

In the News

GENERALSURGERYNEWS.COM M / GENERAL SURGERY NEWS / OCTOBER 2014

higher g risk for wound complications. p “By doing this robotically, I am able to replicate the operation that we do open and place the mesh in the retromuscular position. I’m still able to do a myofascial release or component separation. I’m able to reconstruct the abdominal wall, both above and below the mesh, leaving it hidden from the viscera. In essence, I’ve replicated the open operation with a near nil wound complication rate.” But it’s too early to say what long-term outcomes will be with patients treated robotically, he added. So far, Dr. Carbonell has performed 19 robotic RivesStoppa retromuscular hernia repairs on selected patients who have good integrity of the skin, defects no larger than 11 cm in width and noncontaminated wounds. “It’s still in its infancy. Right now, we’re out a little over a year. When looking at our database, there is a marked improvement in outcomes when you compare the small number of patients that we’ve done robotically with those we’ve done open. It’s an earlier discharge from hospital and zero wound infections in favor of the robotic approach.” He noted that his experience is not enough to justify broader adoption of the robot. “We’re still trying to figure it out. The early results and early experience are very encouraging. But it’s technical. This is not a slam-dunk easy operation that you’re going to have the average general surgeon doing.” To date, fewer than 10 reports of robotic hernia surgery have been published or presented. All are small, singlecenter experiences. None has follow-up beyond two years. The largest study to date came from Baptist Health in South Florida and was

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presented as a poster at the 2013 meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. Surgeons compared their first 67 robotic ventral hernia repairs with their last 67 laparoscopic ventral hernia repairs. Primary closure of the fascia was performed only in the robotic cases. Fixation of the mesh was carried out with tacks and stitches in the laparoscopic ventral hernia repairs and with tacks and intracorporeal sutures in the robotic cases. Analysis showed that surgical times were significantly longer for robotic procedures, at 107 minutes compared

with 88 minutes for the laparoscopic approach. Patients undergoing the robotic procedure had shorter hospital stays, 2.5 versus 3.7 days. Robotic surgery was associated with fewer complications (3% vs. 13%; P P=0.028), recurrences (1.5% vs. 7.5%; P P=0.095) and conversions (1.5% vs. 4.5 %; P=0.310). P However, the study has important limitations: It’s a single-center study with low numbers of patients, limited followup and shorter follow-up of patients who underwent robotic surgery compared with laparoscopic (17.1 vs. 21.8 months; P P=0.006).

“We are cautious with these findings and believe that randomization is necessary to corroborate these preliminary results,” concluded Rupa Seetharamaiah, MD, and his colleagues from Baptist Health South Florida, in Miami. Of all the robotic series presented, none has shown a definitive benefit to robotic surgery and none includes a thorough cost analysis. These series simply confirm the technical feasibility of robotic hernia repair. “There [are] no good data to suggest that robotics and hernia do anything see HERNIA ROBOT page 40

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In the News HERNIA ROBOT jcontinued from page 39

other than prolong the operation and increase the costs. It is used very rarely at this time,â&#x20AC;? said Dmitry Oleynikov, MD, Joseph and Richard Still Endowed Professor of Surgery and director of the Center for Advanced Surgical Technology, University of Nebraska Medical Center, Omaha. Dr. Oleynikov uses a surgical robot in general surgery procedures where a laparoscopic approach is too difficult or cannot be accomplished, such as Heller

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

myotomy, esophagectomy or other complex procedures. He used a robot once in hernia repair to see how the technology worked in that setting but said he was disappointed with the result. â&#x20AC;&#x153;What I discovered was the setup of the robot and the actual benefit of using sutures were fairly minor compared with the quicker laparoscopic approach that I currently use.â&#x20AC;? He said that the robot might provide a small benefit in cases where surgeons would perform a transabdominal pre-peritoneal inguinal hernia repair but noted that is rarely performed in the

United States. â&#x20AC;&#x153;Most American surgeons, however, use a TEP [total extraperitoneal] technique or a total endoscopic pre-peritoneal repair.â&#x20AC;? Michael J. Rosen, MD, professor of surgery and director of Cleveland Clinicâ&#x20AC;&#x2122;s Hernia Center, in Ohio, said he finds it hard to believe that any study will demonstrate enough advantage with the robot to justify the enormous cost of the technology. â&#x20AC;&#x153;Iâ&#x20AC;&#x2122;m very, very suspect about the robot. Itâ&#x20AC;&#x2122;s an expensive tool. From my perspective, if the robot is used in hernia repair, itâ&#x20AC;&#x2122;s incumbent on surgeons to show that

Rationale, Reversal, and Recovery Of Neuromuscular Blockade 3DUW $ 0XOWLGLVFLSOLQDU\ $SSURDFK WR 2SWLPL]LQJ 6DIHW\ DQG (IÂżFLHQF\ Case Study Brenda is a 78-year-old woman undergoing open abdominal surgery to correct symptomatic pelvic organ prolapse. Current Symptoms Â&#x2021; Pelvic organ prolapse failing conservative therapy Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Dyslipidemia Â&#x2021; Type 2 diabetes mellitus Â&#x2021; Glaucoma &XUUHQW 0HGLFDWLRQV Â&#x2021; Ezetimibe Â&#x2021; Glyburide Â&#x2021; Insulin glargine Â&#x2021; Pravastatin Anesthesia is induced with fentanyl 100 mcg, propofol 150 mg, and rocuronium 50 mg and maintained with GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ $PSLFLOOLQ VXOEDFWDP 3 g is given intravenously as well. At 90 minutes after induction, the surgeon reports tension in the surgical ÂżHOG DQG UHTXHVWV DGGLWLRQDO UHOD[DWLRQ 1R PRQLWRULQJ of neuromuscular function is performed.

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â&#x20AC;&#x2DC;Whenever Iâ&#x20AC;&#x2122;m asked about the robot, my answer is always this: â&#x20AC;&#x153;I drive a 2010 Ford F150 to work. Would I love to drive a Rolls-Royce to work? Sure. But it doesnâ&#x20AC;&#x2122;t mean that I need it.â&#x20AC;?â&#x20AC;&#x2122; â&#x20AC;&#x201D;Michael Rosen, MD they can provide value. Iâ&#x20AC;&#x2122;ve yet to see any added value,â&#x20AC;? Dr. Rosen said. He suggested that the robot may be beneficial with the Stoppa technique, â&#x20AC;&#x153;but I donâ&#x20AC;&#x2122;t see any role for [the robot in] standard hernia repairs.â&#x20AC;? Without data, surgeons should be skeptical about the aggressive marketing from Intuitive, he said. â&#x20AC;&#x153;Theyâ&#x20AC;&#x2122;re very good at getting surgeons to say that the robot is beneficial. But thereâ&#x20AC;&#x2122;s nothing to indicate that it is true.â&#x20AC;? â&#x20AC;&#x153;Whenever Iâ&#x20AC;&#x2122;m asked about the robot, my answer is always this: â&#x20AC;&#x2DC;I drive a 2010 Ford F150 to work. Would I love to drive a Rolls-Royce to work? Sure. But it doesnâ&#x20AC;&#x2122;t mean that I need it.â&#x20AC;&#x2122;â&#x20AC;? Guy Voeller, MD, professor of surgery at the University of Tennessee Health Science Center, Memphis, agreed. He said Intuitiveâ&#x20AC;&#x2122;s style of marketing is â&#x20AC;&#x153;not ethical or good for patients. â&#x20AC;&#x153;All you have to do is get one surgeon using the robot and the company will let the other surgeons know that theyâ&#x20AC;&#x2122;re going to lose their business and they have to start using the robot,â&#x20AC;? Dr. Voeller said. He also criticized hospitals for marketing the robot to the public without data to support their claims. â&#x20AC;&#x153;[Hospitals] could get away with this when there was money, but now hospitals are going broke and there is no money for wasteful use of robots.â&#x20AC;? Dr. Voeller, who does not use the robot, called robotic hernia repair a â&#x20AC;&#x153;total waste of time and money from my point of view. â&#x20AC;&#x153;People think the robot means better and there is nothing further from the truth. It does not mean that it should not be investigated in a controlled fashion, but thatâ&#x20AC;&#x2122;s not done, and people are the guinea pigs. â&#x20AC;&#x153;As I see it, if you cannot show true value in using a costly technology, then it should not be used.â&#x20AC;? But Dr. LeBlanc, who led the way in bringing laparoscopy to hernia repair, feels that surgery is on the cusp of a new switch, going from laparoscopic to robotic surgery. â&#x20AC;&#x153;When the adoption of laparoscopic surgery began, we heard that the operations took longer, the costs were higher and there was no proven benefit. Look where we are today. We do need more data but perhaps we are reliving the past.â&#x20AC;?

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

CHIEF RESIDENT jcontinued from page 1

surgical insights that I could pass on to future chief residents. A wise man once wrote, â&#x20AC;&#x153;Wisdom comes from bad experience, and that it is best to learn from someone elseâ&#x20AC;&#x2122;s bad experience than your own.â&#x20AC;? With that, I share some of the pearls I learned during my chief year.

The 101 Tips 1. First, do no harm. No changes here. 2. You may not be right all the time, but by this point you know how to quickly obtain the right answer while maintaining your authority. 3. Residency is like a family, and now you are a parent. 4. Always do your best. 5. Resident safety before your safety. 6. Now you are the backup. 7. Shield your attending from extra work; residents should shield you from extra work; everyone should be kept informed. 8. Interventions are not benign; designate appropriately. 9. Not every patient needs an operation before they die; your logs are not as important as your patientâ&#x20AC;&#x2122;s dignity. 10. Continue to be honest with yourself; strive to be a junior attending while not operating above your ability. 11. Check the OR schedule every Sunday night. 12. Continue to read before cases, even the routine ones. 13. Set the expectation from day 1: Residents are to notify you about all complex cases. Be sure to return the favor regarding simpler ones. 14. Speak upâ&#x20AC;&#x201D;your voice matters more now than it ever has in the past. Donâ&#x20AC;&#x2122;t allow anyone to get hurt. 15. Be a team player on the wards; the nurses and hospital staff are your eyes and your ears. 16. Continue to adhere to the five principles of surgery (the â&#x20AC;&#x153;when you canâ&#x20AC;&#x2122;sâ&#x20AC;?), and keep your significant other up to date on your OR schedule. 17. Donâ&#x20AC;&#x2122;t be afraid to call your patients at home to follow up on them. 18. Write notes on your pre-ops and post-ops; donâ&#x20AC;&#x2122;t pawn this responsibility off to your junior residents. 19. Pride yourself on being a diagnostician. 20. Program your phone with the contact numbers of all attendings; surgical interns/residents; pre-op, OR, and postanesthesia care unit personnel; radiology; emergency room; pathology; the nurse manager; and all wards. 21. Communicate with attendings of other specialties, especially those

taking care of your patients. 22. Choose your battles. 23. â&#x20AC;&#x153;When angry, count to 10 before you speak; if very angry, count to 100.â&#x20AC;? â&#x20AC;&#x201D;Thomas Jefferson 24. Take an entire night off each week. 25. Attempt to do all presentations ahead of time. Make sure presentations are informative and will serve not only to present a topic but also to teach the junior residents and medical students. 26. Exercise when possible, eat healthy when you can; donâ&#x20AC;&#x2122;t let the increase in good eats increase your waistline,

Save your program director from dealing with insignificant resident issues; he or she has enough to deal with as it is. especially during interview season. 27. Give your significant other a courtesy update when you are running late. 28. Sign out ICU post-ops to the ICU resident and/or fellow. 29. Personally evaluate all critical new

consults and patients whose clinical course has suddenly changed. 30. See your post-ops every day, and twice a day if possible. 31. Never let your juniors see you sweat. 32. Save your program director from dealing with insignificant resident issues; he or she has enough to deal with as it is. 33. Take time closing the skin. 34. Ask junior residents and medical students questions on rounds and in the OR. 35. No unnecessary labs/imaging: see CHIEF RESIDENT page 42

Rationale, Reversal, and Recovery Of Neuromuscular Blockade Part 2: Ongoing Challenges and Opportunities Case Study Dennis is a 68-year-old man undergoing open abdominal surgery (colectomy). Current Symptoms Â&#x2021; Dyspnea Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Congestive heart failure Â&#x2021; Obstructive sleep apnea &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol 100 mg PO Â&#x2021; Ramipril 2.5 mg PO Laboratory Results Â&#x2021; Apnea hypopnea index: 26/h Â&#x2021; Left ventricular ejection fraction: 30%-35% Anesthesia is induced with sufentanil, propofol, and 0.6 mg/ kg rocuronium based on total body weight and maintained ZLWK GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ DQG VXIHQWDQLO 6XUJLFDO FRQGLWLRQV DUH GLIÂżFXOW ZLWK D ODFN RI DEGRPLQDO ZDOO PXVFOH relaxation and poor paralysis. An extra dose of rocuronium is administered for deeper neuromuscular block (NMB), and fewer than 2 train-of-four (TOF) responses are noted.

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Opinion CHIEF RESIDENT jcontinued from page 41

challenge yourself with this every day; it will pay off when you’re up for review in a pay-for-performance job situation. 36. Surgery is not a spectator sport; just because you don’t have the scalpel in your hand doesn’t mean you aren’t driving the case. 37. When something goes wrong, try not to lecture, but rather take the opportunity to teach.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

38. Sometimes you will be cranky; just don’t say or do anything that will permanently affect your relationships. 39. Invest time in medical students; they are the future of your program and will help define its legacy. 40. Pick up after yourself at home; your significant other already misses you, don’t make it easier not to. 41. Document, document, document. This was encouraged on day 1 and is being encouraged now. 42. “Don’t start the operation until it is finished.” —Bruce Panasuk, MD

Be careful what you say around your patients. You may be having a bad day; they are likely having one of the worst days of their life. 43. When talking with a patient, look him or her in the eye. Listen. 44. As your surgical career progresses and your responsibilities increase, there will be more and more personal sacrifices.

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45. Dress to impress; you will find that you take your job more seriously. 46. Keep a toothbrush in the call room. 47. Only keep in your white coat what you absolutely need. 48. Keep up with your charts and dictations; do not wait until June. 49. The operation takes a few hours, the patient is in the hospital for a few days; you will likely spend more hours being an internist on the wards than you will being a surgeon in the OR. 50. Toward the end of residency, you will learn more in the clinic than you will in the OR. 51. Continue to be an active member of the OR team—be in the room for intubation, extubation and to help move the patient. 52. Present your morbidities and mortalities, always. 53. Always keep a phone charger with you. 54. Be flexible with your vacations. 55. If you are called, always try to help, even if you are not on call. 56. Don’t just scrub cases in the specialty you are focused on; you’ll be thankful the day you need a 5-0 prolene to save a patient’s life. 57. Attempt moderation in all things, but always drink enough coffee. 58. If too tired to read, watch surgery online. 59. You will probably end up swallowing your pride more in your chief year than in your intern year. 60. Participate in a research project. 61. Never criticize your fellow chiefs behind their backs. 62. Take pride in your case logs and dictations—make them accurate, honest and timely. 63. Review your anatomy. 64. Iron fist, velvet glove. 65. Be careful what you say around your

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

destroy it. 84. Strive to drive—the work-up, the case, the postoperative course. 85. Find some way to participate in a mock oral exam. 86. Try to do something philanthropic this year. 87. If you haven’t gone to a national conference, find one and go to it. 88. Providing “lunch on the chief ” always helps build morale. 89. Find a good nonsurgical book and read it. 90. Always end each conversation with patients and their families by asking

patients. You may be having a bad day; they are likely having one of the worst days of their life. 66. Wash your hands. 67. Only put your trust in those who have truly earned it. 67. Learn when not to operate. 68. Clean up after yourself—in the OR, on the wards, in the call room. 69. Either write or review your post-op patient’s discharge instructions. 70. You have probably lost a few hobbies along the way; this year, try to resurrect an old hobby or find a new one. 71. Your attending may only be one year your superior, but he or she is still your attending.

Never argue with or contradict another colleague in front of a patient. 72. Don’t just do major cases; your first case will likely not be a major case. 73. Be able to put in a peripheral IV. 74. Be on time. 75. Strive to be autonomous, but remember, attendings hate surprises. 76. Always read your own films; confirm them with a radiologist when appropriate. 77. Good or bad, you can learn something from everyone. 78. Laugh. 79. Check all your patient’s labs, films and vital signs. 80. Never argue with or contradict another colleague in front of a patient. 81. It may not be your first rodeo, but it likely is a new bull. 82. It is OK to round on your patients on your day off; they will appreciate it. 83. It can take four years to build your reputation, and one bad moment to

what questions they have. 91. Take the stairs. 92. Regarding the next step in your career, always have a contingency plan. 93. If you don’t have it already, get personal injury protection insurance. 94. When discussing a situation with another colleague whom you do not entirely agree with, begin your response by saying, “That’s a great idea …” 95. Eat breakfast. 96. If you change a resident’s order, tell him or her why you are changing it.

97. Leave OR shoes at the hospital. 98. Team-build with your fellow chiefs; plan some fun activities with them and their significant others. 99. Solidify your class’ legacy by helping to plan a nice graduation ceremony. 100. Take pictures. 101. “Courage is being scared to death and saddling up anyway.” —John Wayne —Dr. Flaherty is a surgical oncology — fellow at John Wayne Cancer Institute, Santa Monica, Calif.

Opinion IN

THE

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

DARK

jcontinued from page 1 feel that he or she is essential to the successful conduct of the operation but simultaneously completely interchangeable. The plan conjures the image of a surgeon run amok, a raging primate slamming against the cage bars who is subdued by rational staff. And it clearly sanctioned a redistribution of power, whether the surgeon misbehaves or not, because it installed a de facto guardianship. What is strikingly odd is that the time-out formalizes a conversation among the OR team members about the task at hand that ostensibly could help the surgeon achieve the goals of the procedure and avoid errors. Why have surgeons resisted this? And if we have submitted because “we have to,” why haven’t we embraced this and tapped its potential to help us? Why haven’t we owned it? Policies like my hospital’s are a 911 call. Our failure to recognize it as such is the moral equivalent of being in denial about postoperative bleeding. We cannot afford to avoid taking inventory of our behavior individually or collectively, because the loss of credibility exacerbates the very work conditions and feeling states that contribute to unproductive behavior in the OR. Avoidance will further deteriorate relations with the people with whom we work and make it harder for us to engage them to create solutions. Many surgeons say, “Why bother? This is unfixable. Better to just endure and try not to react.” But the truth is that this kind of resignation, while seemingly well matched to a surgeon’s practicality, is itself a variant of disengagement. Disengagement is a hallmark of burnout, and more often than not, it reflects superficially neutralized resentment rather than heartfelt acceptance. Disengagement is akin to objectivity, which is necessary to exercise rational judgment in crisis but can veer into detachment. Furthermore, by failing to address this crisis, we are destined to reckon with policy-driven solutions that control behavior in the most rudimentary ways and fail to address the underlying conditions that lead to undesirable, unproductive behavior. We are sometimes angry and disappointed, but we are likewise sometimes ashamed, and it is difficult to disentangle the two. Because we almost all fail a little bit, we draw the mantle of charity over our colleagues who fail massively. If we don’t know how to master our own disappointments, how can we hope to help a colleague address his or her own? We share our frustrations openly with one another and anyone else who will listen, but we have little insight into our own ideals, our professional standards, for conduct. By ignoring our own small failures, we deny ourselves the opportunity to see what they signal and to be stewards of our own well-being. The time-out was introduced under the rubric of patient safety, but as with most initiatives in a complex social environment, the motives for and consequences of its establishment are multifaceted. Some of the issues that contribute to surgeon resistance to the timeout are difficult to discuss openly; but left in the dark, they drain the potential that the time-out has to help us provide the best care possible, to ease some of our own stress and to improve strained relations in the OR. Some of surgeons’ resistance to the time-out exists due to the following: • It requires a change in time management because the attending surgeon must be in the room at the start of the case. This encroaches on the surgeon’s already limited time when the practice has been to have a

Advocating for patients is something that everyone in the hospital must do, and claiming this as a distinct professional identity tends to draw lines between providers and our intentions ...

•

resident or fellow prep, drape and make an incision. It requires a change of practice that is especially challenging if the benefits of the activity are not clear and it is just another rule to be followed, initiated by people who are not ultimately accountable in the uniquely individual way that the surgeon is and who work a shift. It presumes shared authority by team members who are not accountable for the outcome of the procedure. OR staff, apart from the anesthesiologist, may feel emotionally or professionally invested in the outcome, but they won’t be named, blamed or sued. It demands translation of a complex and potentially evolving operative plan for staff with less sophisticated comprehension of the goals, who then “supervise” the activity. It exacerbates tension that develops when nurses assert themselves as “the patient’s advocate.” Advocating for patients is something that everyone in the hospital must do, and claiming this as a distinct professional identity tends to draw lines between providers and our intentions, and expresses doubt about the moral commitment of “self-serving” surgeons in contrast to “selfless” nurses. Surgeons therefore may regard the time-out as a nuisance that has been visited on us by “the patients’ advocates” to help protect the patients from us. It recruits us to substantiate the “level hierarchy” in the OR instead of fostering the more realistic concept that we have an interdependence of committed individuals with different degrees of responsibility,

intellectual engagement, accountability and interest. Each person contributes, has a stake in the outcome, is necessary to the performance of an operation, and has dignity, but although it might be equitable (“each in accord with his or her ability”), other than with regard to personal dignity, it is not equal. • It challenges the surgeon’s dictum, “trust no one.” A core principle of surgical indoctrination is to rely on no one and blame no one for our decisions or performance. At the end of the day, one person wields the knife. • It challenges our autonomy and threatens to decrease our authority, but not our accountability. There are other obstacles, but we can learn a lot by evaluating these: Time management. I know exactly how many hours there are in a week: 168. And the reason I know is because of the number of hours I have spent in the hospital year after year. We learn to be efficient and squeeze everything out of each minute because “the longer we stay, the longer we stay.” Our lives go by without us. We also do this to try to earn the most we can, most efficiently. Somewhere, this intersects with greed. We all know it, and other than in the arena of taking payment as an expert witness, we really don’t have any standards. Also, because we don’t openly value our work financially for fear of patients’ judgment, these practices are negotiated clandestinely. In this reimbursement climate, we agree to do more and more work for less money and find ways to cut corners to maintain the income we see IN THE DARK page 46

GSN Bulletin Board

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2014

‘The Ocean’s Waters Are Never Still’ You might have to fend off an attack from pirates or a rogue submarine that shoots a torpedo your way. But you will make your journey across the mighty had an opportunity to walk out of the ocean. It won’t be easy, but you’ve been trained hospital recently with one of the future to make it across. chief residents. He is a young, talented “You will, after a time, get your 'sea legs.’ individual who is very pensive and obser- The minor waves won’t even catch your vant. He commented on his recent obser- attention after a while.” I further comvation that the only constant in medicine mented that someone should have is change. I asked him to explain. After a told him this in high school, college few minutes, I understood his perspective. He remarked or medical school. It took me several that there are changes in medical billing, changes in years as an attending surgeon to learn upcoming ICD [International Classification of Diseas- it, but life isn’t about looking for the es]-10, changes in resident work “still waters”; it is about hours, changes in quality mealearning to navigate the The journey of life sures, changes in insurance comstormy sea and make pany contracts, changes in SCIP isn't about finding the it across. “You have the [Surgical Care Improvement Projtranquil lake where talents and the training ect] protocols, changes in surgical to be the captain of this you can hear the techniques and, finally, changship and you won’t sink.” es in medications prescribed. He We smiled at each other, leaves rustling in the said that after four years of being and he went back into background from a a surgical resident, the only part of the hospital. I got into my the “being a surgeon” equation he gentle breeze. That's car, and as I was driving off, I understood was the variability. He thought about the analogy further. not reality. Reality is I thought about the shipyard where wondered what was in store for him and his family over the next I was built. The initial journey until I, the ocean. 30 years of his surgical career. myself, lost sight of the land. The other My response was, “the ocean’s ships I had passed on my journey across waters are never still.” He looked at me questioning- the sea. The different harbors in which I docked; the ly, and so I went on to explain. “Pretend you are a ship’s ones I didn’t. The beautiful sunsets I had witnessed, and captain manning your ship, sailing across the Atlantic the terrible storms I had survived. The pirate ships I Ocean, traveling from America to Europe. You can’t had warded off. expect the voyage to be calm. There will be peaks and And then I realized that I had to share this analogy. valleys; swells and troughs. There will be waves that will To help teach some other sailors and captains out there, try to capsize your vessel. There also will be helicopters that the journey of life isn’t about finding the tranquil that come drop off much-needed supplies. There will lake where you can hear the leaves rustling in the backbe strange sightings, maybe even a sea monster or two. ground from a gentle breeze. That’s not reality. Reality B Y M ARC A. N EFF , MD

THE

DARK

jcontinued from page 44 have enjoyed. Perhaps if we dealt with these issues more directly, we would find we had time and valued being in the OR with our patients as they go to sleep, and that our considered presence is necessary to help create the sacred space in which a remarkable human transaction is taking place. Authority. If we assessed and honored the differences among the team members in the OR, if we actually tried to understand one another and allow for our differences, we would more effectively draw on one another’s strengths, understand our burdens and communicate more effectively. We could have genuine regard for the contributions of each team member, make appropriate demands, and shower the appreciation on one another that every person desires. We might also go some distance

to combat the kind of isolation that we feel as surgeons that increases our suffering. We could rely a bit more on the other people in the room to help us perform at our best. This isolation can lead to resentment, anger, fear and frustration—none of which enhances our ability to express our original, sacred intention that inspired our work as surgeons.

is the ocean: teeming with life and adventure and challenge and danger and the unknown just over the horizon. —Dr. Nefff is director, Bariatric Surgery Program, — Kennedy University Hospital, Cherry Hill, N.J.

to regard it as a time to generate expectations and unite us in our effort rather than merely reciting the template? When I complained to one savvy OR administrator that it is difficult to keep the tech and the scrub engaged through the course of an operation, he acknowledged that we are different in our abilities and focus. Would it work, he asked,

Perhaps if we dealt with these issues more directly, we would find we had time and valued being in the OR with our paitents as they go to sleep, and that our considered presence is necessary to help create the sacred space in which a remarkable human transaction is taking place. The time-out creates an opportunity for real communication with our fellow teammates as we embark on the always amazing venture of operating on a patient. What happens when we try

if you could identify two or three key steps in the operation during which you really, really need their attention? Could you articulate these at the start of the case and then signal when you

arrive at those steps during the course of the procedure? What a difference it has made to outline these (for me, usually the division of major vessels, rectal transection and bowel anastomosis). Staff have been uniformly accommodating to not leaving the room and to paying quiet attention during these critical steps of a case. They feel important, and they are. And I know I can count on them, which gives me peace of mind. We cannot afford to be left in the dark in the OR. Our professional stature and personal well-being are at stake, and it turns out they are more entwined than we were ever encouraged to acknowledge or attend to during our training. —Dr. Kosinskii is a Scholar in — Residence, Department of Surgery, Weill Cornell Medical College, New York City, and Assistant Clinical Professor, Department of Surgery, Medical College of Wisconsin, Milwaukee. She also blogs on her website, surgeonsgyre.com.

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