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GENERALSURGERYNEWS.COM
July 2012 • Volume 39 • Number 7
The Independent Monthly Newspaper for the General Surgeon
Opinion
New Fixation Technique Cuts Tacks Needed In Hernia Repair
Food for Thought B Y L AUREN K OSINSKI , MD, AND F REDERICK L. G REENE , MD
I
t was intriguing to hear the recent news that the Disney Company was beginning an initiative to promote good nutritional choices by only accepting food product advertisers that promoted healthful options. We should applaud the company’s initiative to combat the obesity epidemic by encouraging its young audience to associate the magic of Disney with healthful foods. A slew of other recent initiatives have tried to encourage better eating habits among young people. Sixteen years ago, Alice Waters, the celebrity chef founder of Chez Panisse Restaurant credited with introducing nouvelle cuisine to American diners, established an Edible Schoolyard Project and School Lunch Initiative in Berkeley, Calif. These programs were built on the nouvelle cuisine concept emphasizing eating fresh, locally grown and seasonally available foods prepared in uncomplicated ways that enhanced the natural flavors of the
May Lessen Post-op Pain B Y C HRISTINA F RANGOU
these patients as a primary treatment option. “Our initial algorithm for patients with medically refractory gastroparesis who needed surgery was placement of a stimulator as a first-line of treatment, and if that fails, a laparoscopic subtotal gastrectomy,” said
NEW YORK K—Spanish surgeons have reported a new method of mesh fixation for laparoscopic ventral hernia repair that significantly reduces the number of tacks required and may diminish patients’ postoperative pain. This new technique uses a combination of tacks and fibrin glue placed in a double-crown technique. “I think with this study, we have shown the feasibility of this technique, which decreases mechanical fixation and should reduce acute and postoperative chronic pain without increasing the recurrence rate,” said lead author Salvador MoralesConde, MD, chief of the Advanced Laparoscopic Unit of the University Hospital Virgen del Rocío in Sevilla, Spain. Dr. Morales-Conde presented the results at the Fifth International Hernia Congress (session 7C abstracts). Previous studies have drawn a link between pain and the number of tacks (Br J Surg 2011;98:1537-1545), which is why Dr. Morales-Conde and her team set out to develop a technique that would reduce the number of tacks required. For this technique, surgeons put the mesh in place and deposited four tacks into the mesh at cardinal points around the mesh perimeter. They then marked all the spots where they would usually put tacks, leaving less than 1 cm between each mark. After marking the exterior and inner ring
see GASTROPARESIS AND GES page 36
see TACKS page 32
“Failure To Pursue Rescue” Ups Deaths From Complications B Y C HRISTINA F RANGOU
E
lderly patients who sign a preoperative “do not resuscitate” order are more likely to die from
complications following surgery than matched controls because they turn down aggressive management of their complications, according to a see RESCUE page 33
Lap Subtotal Gastrectomy Could Be Primary Gastroparesis Therapy Similar Morbidity, Mortality as GES With More Symptom Improvement; Temporary GES May Be Viable Alternative
see FOOD FOR THOUGHT page 34
B Y M ONICA S MITH
REPORT Benefits of GORE® DUALMESH® Biomaterial in Hernia Repair: A Case-based Presentation See insert avÌiÀ page {0
®
SAN DIEGO—Gastric electrical stimulation (GES) can improve symptoms in patients with gastroparesis, but after retrospectively reviewing patient outcomes, researchers at the University of Southern California are now offering laparoscopic subtotal gastrectomy to
INSIDE On the Spot
Obituary
Surgeons’ Lounge
Watch and Wait for Rectal Cancers? Surgeons and Oncologists Discuss ..........4
The MetropolitanMemorial Center Patient Chart Dies at 110 ........... 14
Managing the Patient With Epiphrenic Diverticula ..... 24
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Irrigation No Better Than Suction for Perforated Appendicitis Randomized Study of 220 Children B Y C HRISTINA F RANGOU
P
eritoneal irrigation offers no advantage over suction alone during laparoscopic surgery in children with perforated appendicitis, according to a prospective, randomized trial presented at the 132nd annual meeting of the American Surgical Association (abstract 19). In a trial involving 220 children, researchers found outcomes were unchanged when surgeons performed peritoneal irrigation for perforated appendicitis rather than suction alone. The study showed similar rates of abscess, location of abscesses, hospital length of stay (LOS), narcotic doses and hospital charges when children had peritoneal irrigation or suction alone. “I would say this study is definitive, after 110 observations in each group and absolutely no differences between groups in outcomes, that a moderate volume of saline irrigation does not affect outcome during laparoscopic appendectomy for perforated appendicitis in children,� said Shawn D. St. Peter, MD, director of the
Center for Prospective Clinical Trials and a pediatric surgeon at Children’s Mercy Hospital, Kansas City, Mo. The results, however, cannot be extrapolated to other contaminated cases, he cautioned. The debate over irrigation of the peritoneal cavity has gone on for more than a century, with the first reports of irrigation dating back to 1906. However, robust studies in patients with perforated appendicitis are few and all previous studies were conducted in the pre-laparoscopic era. Anecdotal reports suggest surgeons are split over whether to irrigate for a perforated appendix. Dr. St. Peter and his colleagues designed a prospective, randomized trial to compare the effects of irrigation with those of suction alone during laparoscopic appendectomy in children with perforated appendicitis. Perforation was defined as stool in the abdomen or a hole in the appendix. Researchers randomized 220 patients, 110 in each arm, to undergo irrigation with a 1-L bag of normal saline attached to the suction irrigator or to suction alone. The two groups were well matched with a mean age of 10 years, weight of 41 kg and body mass index in the 60th to 65th
Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC General Surgery, Laparoscopy, Surgical Oncology
Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN General Surgery, Laparoscopy, Surgical Oncology, Ultrasound, Endoscopy
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percentile. Both groups had symptoms and temperature of 37.8°C for three days prior to surgery. All patients underwent a standard three-port appendectomy, followed by placement of a Foley catheter and oncedaily dosing of IV ceftriaxone (50 mg/ kg) and metronidazole (30 mg/kg) with the regimen outlined in a previous trial on antibiotics from the same investigators. Standard patient-controlled analgesia was used for pain control postoperatively. Patients had similar outcomes, regardless of whether they had peritoneal irrigation. Eighteen percent of irrigated patients developed abscesses compared with 19% of nonirrigated patients. Irrigation did not affect the location of the abscesses, the number of drains placed, days of drainage, the hospital LOS, the return to regular diet or ultimate cost. Both groups of patients returned to regular diet in 3.5 days, and remained in the hospital 5.5 days. The hospital charges were the same, at around $48,100, for both groups of patients. One child who was randomized to suction alone underwent irrigation instead due to surgeon preference. Three patients who underwent suction alone developed postoperative bowel
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Š 2012 by McMahon Publishing, New York, NY 10036. All rights reserved. General Surgery Newss (ISSN 1099-4122) is published monthly by McMahon Publishing, 545 West 45th Street, New York, NY 10036. Corp. Office, 83 Peaceable Street, Redding CT 00896. POSTMASTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, New York, NY 10036.
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obstruction compared with one in the irrigation group. The difference was not significant, investigators said. The only difference that approached significance was operative time (P=0.056); P however, irrigation prolonged surgery by only four minutes (38.7 vs. 42.8 minutes). The study stands out for its randomized, prospective format—the latest in a long series that the team from Kansas City has completed, said Michael G. Sarr, MD, James C. Mason professor of surgery at Mayo Clinic, Rochester, Minn. Dr. Sarr cautioned, however, that the rigid design of the study limits some of the conclusions. The surgeons used a minimum 500 cc to irrigate and had a mean volume of irrigation of 867Âą327 cc. More volume and an irrigation that contained antibiotics may have had greater influence, he said. Also, irrigation was localized to the area around the appendix. “This shows definitively that irrigation of less than 1 L in the area around the appendix makes no difference. However, because abscesses also occurred in other distant areas of the abdomen, we don’t know whether intense irrigation throughout the peritoneal cavity would have prevented these abscesses,â€? said Dr. Sarr.
Mission Statement It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.
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INFECTIOUS DISEASE SPECIAL EDITION
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O nthe On the Spot
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with Colleen Hutchinson
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
&
Watch
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s I wrap up this column on the eve of the World Congress of Endoscopic Surgery in Puerto Vallarta, which many of my colleagues attended, I am reminded of how dedicated these colorectal surgeons and oncologists are to innovation, education and surgical and oncological advancement. Some of the contributors in this installment stayed at work late to provide their responses; some wrote theirs over their weekend—carving out time that they share with their families; and some did it on the plane to Puerto Vallarta. I even had one person send his from an airport in Asia during a layover. Thank you to all of this month’s contributors for their candid beliefs, opinions and observations, and most importantly for the time it took to share them. Where would we be without the thought leaders who operate, innovate and educate in their own operating rooms and across the globe? There will be broader discussion of medical innovation in an upcoming installment of On the Spot, but this month’s column centers on innovative approaches in colorectal
Wait for Rectal Cancer?
surgery and highlights topics that develop at the intersection of colorectal surgery and colorectal oncology—including neoadjuvant therapy, transanal endoscopic microsurgery, watch and wait, and what the colorectal surgery patient deserves to know. We not only have the surgeon’s perspective, but as you will see from our contributor biographies, we also include the views of some of our finest oncologists. All of these areas of debate were covered at the Eighth International Rectal Cancer Consensus Conference at Lankenau Medical Center. Also at that meeting, the formation of the new Multidisciplinary International Rectal Cancer Society was announced, and we have here a message from its founders: The past decade has given witness to a sea change in the management of the patient with rectal cancer. As new approaches evolve, each apparent discovery brings with it new and unexpected questions. Proper consideration of these questions and the formulation of personalized patient care guidelines aimed
at providing the highest quality of life while maximizing cure demand a multidisciplinary approach by dedicated experts. General Surgery News, s by providing a forum for airing some of the many penetrating issues with commentary by the experts, offers an opportunity to sensitize and enlighten the readership of the need to remain alert to evolving data that shift treatment paradigms. The members of the recently organized Multidisciplinary International Rectal Cancer Society wish to express their appreciation to the editors of General Surgery News for permitting this timely and important dialog. So read on for some illuminating perspectives on the topics all colorectal surgeons and oncologists must keep abreast of to best serve their patients, and a special thank you goes out to Dr. Gerald Marks, a true pioneer in colorectal surgery, for being a shining beacon of innovation and patient advocacy in a distinguished career that continues today. see RECTAL CANCER PAGE 6
PARTICIPANTS Theodore Saclarides, MD, is director of the Division of Colorectal Surgery at Loyola University Health System, and professor of surgery at Loyola University Chicago Stritch School of Medicine, Chicago, Ill. John H. Marks, MD, is chief of the Section of Colorectal Surgery of Main Line Health and program director for the Fellowship in Minimally Invasive Surgery and Rectal Cancer Management at Lankenau Medical Center, Wynnewood, Pa. Richard M. Goldberg, MD, is Klotz Family Professor of Medicine and physician in chief of the Arthur G. James Cancer Hospital at the Wexner Ohio State Medical Center and associate director of the OSU Comprehensive Cancer Center. Dr. Goldberg is a gastrointestinal medical oncologist mainly focused on treatment and research in colorectal cancer.
Gerald Marks, MD, is professor of surgery and colorectal surgeon at Lankenau Medical Center, Wynnewood, Pa.
Rodrigo Perez, MD, is professor of surgery, University of Sao Paulo School of Medicine, Sao Paulo, Brazil.
Conor P. Delaney, MD, is chief of the Division of Colorectal Surgery, surgical director of the Digestive Health Institute, vice chairman of the Department of Surgery at University Hospitals Case Medical Center, and professor of surgery and director of the Center for Surgery and Simulation at Case Western Reserve University in Cleveland, Ohio Albert S. DeNittis, MD, is clinical associate professor at Lankenau Institute for Medical Research, and chief of radiation oncology at Lankenau Medical Center, Wynnewood, Pa.
Angelita Habr-Gama, MD, is professor of surgery, University of Sao Paulo School of Medicine, Sao Paulo, Brazil.
Tim Nguyen, MD, is a gastrointestinal medical oncologist at the Cleveland Clinic in Weston, Fla.
Brad Champagne, MD, is associate professor of surgery in the Division of Colorectal Surgery at Case Western Reserve Medical Center and University Hospitals of Cleveland, and program director for the Accreditation Council for Graduate Medical Education Colorectal Residency and surgical director of the Community Center of Excellence, Digestive Health Institute.
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On the Spot RECTAL CANCER jcontinued from page 4
☛
Patients deserving radical rectal resection should always be informed of the laparoscopic option.
Statement
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
‘Knowing the variability of methods and incisions used for laparoscopy, and especially laparoscopy for rectal cancer, it is no surprise that shortterm benefits have been called into question.’ —Conor Delaney, MD
Dr. Goldberg: The current ACOSOG (American College of Surgeons Oncology Group) trial is evaluating the relative risks and benefits of laparoscopic versus open rectal surgery. In the COST (Clinical Outcomes of Surgical Therapy) trial run by the ACOSOG and the North Central Cancer Treatment Group (NCCTG) in the 1990s (N Engl J Medd 2004;350:2050-2059), this technique was proven to be both safe and effective for colon cancer resection. A cautious approach to the integration of this technique in patients who are not enrolled in clinical trials is prudent until data becomes available from the studies under way.
Dr. Champagne: I disagree. For colon cancer, however, they should always be informed.
Dr. Saclarides: Patients should be informed about laparoscopy, and included in the discussion should be the fact that a prospective, randomized, nationwide multi-institutional trial is under way in the United States to determine its efficacy compared with open surgery. Until these data are available, the surgeon should do his or her best operation that follows the basic principles of obtaining negative margins and doing the level-appropriate mesorectal excision for lymph node clearance.
Dr. Nguyen: Agree. In a retrospective study, disease-free and overall survival seem to be comparable with open surgery but with less postoperative complications and shorter hospital stay.
have been performed for rectal cancer, but these studies now include several randomized trials and many large comparative series by experienced surgeons. Not surprisingly, laparoscopy has again shown equivalent oncological outcomes to open surgery. Short-term benefits for rectal cancer have been similar to colon surgery. Knowing the variability of methods and incisions used for laparoscopy, and especially laparoscopy for rectal cancer, it is no surprise that short-term benefits have been called into question. I think surgeons and patients need to remember that an operation is not laparoscopic simply because it is called laparoscopic. For rectal cancer surgery, specimen extraction sites—the largest incision—have been as large as Pfannenstiel or lower midline incisions for laparoscopic-assisted surgery, or as small as transanal or transostomy site extraction. In my own practice, most patients with rectal cancer have the specimen removed through the ileostomy site, and go home on acetaminophen for analgesia, with three other 5-mm port sites. I believe these outcomes and potential for recovery need to be discussed with patients who have rectal cancer.
Dr. J. Marks: On the fence. For colon cancer I would give an unqualified “agree”! The data are overwhelming in favor of laparoscopy. In fact, if open surgery was somehow the new procedure it would never be allowed to be adopted, based on all the studies. For rectal cancer, there are very promising individual and specialized center data, but this hasn’t been validated yet in a prospective randomized trial. The ACOSOG Z6501 trial is under way and should address this issue. With a personal experience of more than 300 laparoscopic transanal endoscopic microsurgery (TEM) resections and a local recurrence rate of less than 5%, I am confident of what the outcome will be, and I believe it will favor the laparoscopic approach.
Drs. Habr-Gama and Perez: Dr. Delaney: I agree that laparoscopy almost always should be discussed for radical rectal cancer surgery. Although there are some patients who are not candidates because of morbid obesity, multiple prior operations or requirements for multivisceral resection, the majority of patients are candidates for a laparoscopic approach. Many randomized controlled trials and meta-analyses have clearly shown that patients with colon cancer have better outcomes with laparoscopy—at least equivalent oncological outcomes, with lower complication rates, less pain and earlier recovery. Fewer studies
Dr. G. Marks: Agree, with hesitancy. Just as colon cancer is effectively and advantageously managed laparoscopically, it appears that surgery for rectal cancer may enjoy the same benefits. Although I am inclined to say that patients should be informed of the option as a matter of informed consent, we probably are not there yet because the conclusive data are not in hand.
☛
Local excision without neoadjuvant therapy should be the standard for T1 rectal cancer.
Statement
Drs. Habr-Gama and Perez: No! Standard treatment for T1 rectal cancer should be total mesorectal excision. Local excision should be considered an alternative treatment strategy, particularly for frail patients unable to undergo major abdominal surgery or for those who refuse abdominal perineal excision when this treatment is the primary surgical alternative. There is hope that neoadjuvant chemoradiotherapy (CRT) followed by local excision will be a valid and appropriate treatment strategy in the future for these patients.
Dr. Champagne: I agree as long as there are no high-risk features and the risk for recurrence is well explained to the patient who would otherwise tolerate a formal resection. The patient can then make an educated decision about surveillance or more surgery.
Dr. G. Marks: Disagree. A treatment failure for a T1 cancer in my mind is unpardonable, and the reported local failure rates for local excision alone are unacceptably high. Radical resection with sphincter preservation or full-thickness local excision (FTLE) after neoadjuvant CRT is preferable.
Dr. Goldberg: In the hands of expert surgeons and with compulsive visual follow-up, the outcomes for local excision with T1 lesions are excellent and avoid the need for more aggressive therapy and the potential long-term complications of radiation or more extensive surgery. It is critical to scope patients regularly to permit early detection and definitive management of local recurrence.
Definitely!
Dr. DeNittis: Agree. Surgical ability, however, plays a role here. Laparoscopic resections are limited by the number of surgeons who can perform them. If not performed properly, the patient can be at risk for increased recurrence rates with increased local quality-of-life issues.
Dr. J. Marks: Disagree. The results to date, from major centers, show failure rates anywhere from 5% to 19% with T1 cancers treated by local excision alone. This is unacceptable for a group of patients who should have the best results, and the local recurrence rate for unfavorable cancers at our institution and other places is only 3%. For selected cancers (SM1 or very small foci of cancers), as with medically compromised patients, it is an excellent option. see RECTAL CANCER PAGE 8
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On the Spot
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
RECTAL CANCER
‘Selective TEM/FTLE is an acceptable option in the downstaged rectal cancer.‘
Dr. Nguyen: Agree. For T1 disease, local control and survival are not improved by addition of neoadjuvant CRT.
—Gerald Marks, MD
Continued from page 6
Dr. DeNittis: Disagree. Due to the high local failure rates and possibility of lymph node metastases, I don’t know why one wouldn’t consider neoadjuvant therapy. It seems we have a chance here
to cure this subgroup of patients but offer them suboptimal therapy. If neoadjuvant CRT is not considered, then radical resection should be performed. In our experience with high-dose radiation to 5,580 cGy prior to surgery, patients do extremely well.
☛
Selective Dr. Saclarides: This statement Statement may apply for most T1 rectal canTEM/FTLE is cers; however, the surgeon needs acceptable for the downstaged distal to review the slides with a patholrectal cancer. ogist who has a dedicated interest in gastrointestinal cancers. If there is deep penetration into the submucosa, or the lesion is poorly differDr. G. Marks: Agree. Selective TEM/ entiated or has lymphovascular invasion, FTLE is an acceptable option in the then radical surgery is probably prefera- downstaged rectal cancer, particularble. If local excision is chosen, the patient ly when the surgeon cannot technically must be informed about recurrence rates offer sphincter preservation. Secondary of about 10% and should undergo close determinants come into play and radiperiodic follow-up so that recurrences can cal restorative resection for the young, be salvaged. fit patient offers a statistical advantage. Reading between the lines, the issue of the timing of surgical decision making is the pivotal point. The state of the cancer after neoadjuvant therapy and a suitable interval should determine the surgical decision.
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‘There are tumors that respond slowly and the patience to wait for that response is very important. We are finding that some patients can be long-term survivors with local surgery alone.‘ —Albert S. DeNittis, MD
Dr. Goldberg: Most patients should be enrolled in trials to help to better define the relative outcomes of these approaches compared with standard abdominal perineal resection or low anterior resection. In selected cases where patients refuse definitive surgery or are too high-risk medically for surgery due to comorbid medical conditions, this approach can be considered with careful review of the risks and benefits. Compulsory screening for local recurrence, as well as systemic imaging, should be a part of any postprocedure surveillance plan.
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Drs. Habr-Gama and Perez: Despite this treatment strategy sounding appropriate, long-term oncological outcomes are yet unavailable. Considering that the risk for nodal metastases is closely related to final pathologic ypT status, TEM/FTLE may be acceptable for ypT0 and ypT1.
Dr. Saclarides: Even if downstaging has occurred with neoadjuvant therapy, radical surgery is still the surgical
On the Spot
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
option of choice because residual cancer may be present in endoscopically normal areas far removed from the post-treatment scar or ulcer. TEM/FTLE in this setting is an option, however, for elderly patients, patients with comorbid conditions that render radical surgery risky or for patients who absolutely refuse to have a stoma for life.
Dr. DeNittis: Agree. Determining the type of surgery on a patient-by-patient basis in this subgroup of downstaged patients is critical. The timing of the type of surgical procedure should be eight to 10 weeks post-therapy. There are tumors that respond slowly and the patience to wait for that response is very important. We are finding that some patients can be long-term survivors with local surgery alone.
‘The challenge remaining for all local therapy is to predict which rectal cancers will have lymph node involvement. Armed with this knowledge, I would advocate TEM much more aggressively, but unfortunately we are still grappling with this issue.‘ —John Marks, MD
Dr. Nguyen: On the fence. Although few retrospective studies suggest TEM/ FTLE is safe for T3 downstaged to T0 to T1 after neoadjuvant CRT, no randomized study has been conducted to answer this question. Having a complete responder of the rectal lesion on TEM/ FTLE is not equal to no residual disease in the lymph node or mesorectum.
Dr. J. Marks: Agree. This is an excellent option, especially when the other alternative is an abdominoperineal resection (APR). Pathologic ypT3 or node-positive disease should be followed then by a radical resection. The decision should be based on the characteristics of the cancer after therapy. The lesion should be nonulcerated and less than 4 cm. All of the mural induration with a 1-cm margin must be excised. Using this approach, we have had a 4% local recurrence, but longer follow-up is needed.
Dr. Champagne: Disagree. This may become standard in the next decade as we become more adept at determining which tumors are amenable to this approach. However, for now, it is only acceptable in patients who cannot tolerate formal resection.
Dr. Saclarides: My response is the same as for the preceding statement. TEM, however, does provide longer reach and improved access to lesions in the mid and upper rectum.
☛
Selective TEM/FTLE for the down-staged rectal cancer should not be limited to the distal rectum.
Statement
Dr. G. Marks: Agree. TEM in the hands of the proficient surgeon permits safe sphincter-preserving FTLE for cancers in the mid and upper rectum when general and local factors indicate the advisability of FTLE.
Drs. Habr-Gama and Perez: Selective TEM/FTLE for the downstaged rectal cancer shouldd be limited to the distal rectum.
Dr. J. Marks: Agree. TEM gives the ability to extend local excision into the proximal rectum. With pathologic complete response ranging up to 30%, this approach offers an excellent option. Of course, the challenge remaining for all local therapy is to predict which rectal cancers will have lymph node involvement. see RECTAL CANCER PAGE 10
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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
RECTAL CANCER jcontinued from page 9
Armed with this knowledge, I would advocate TEM much more aggressively, but unfortunately we are still grappling with this issue.
Dr. Goldberg: If the experienced surgeon is confident that higher rectal tumors can be excised transanally and pathologic review is favorable for clear margins, this approach can be considered
Dr. DeNittis: Agree. When selecting the patient appropriately, FTLE is an excellent option for the mid to upper rectum, provided the surgeon has the proper technical expertise and is fully knowledgeable from the oncologic standpoint.
‘TEM for the downstaged rectal cancer can be performed for mid and upper rectal cancers.’ —Tim Nguyen, MD
in tumors that are not in the distal rectum and that have been downstaged by preoperative neoadjuvant therapy. This is not a standard approach at this time, however.
Dr. Nguyen: Agree, TEM for the downstaged rectal cancer can be performed for mid and upper rectal cancers.
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☛
Watchful waiting for the complete responder should be restricted to institutional review board (IRB)approved study programs.
Statement
Dr. Saclarides: This statement is absolutely true and the patient should be informed that watchful waiting is not the standard of care in the United States.
Drs. Habr-Gama and Perez: Watchful waiting should be restricted to centers with expertise in rectal cancer management and multidisciplinary settings.
Dr. Goldberg: It is clear that complete response is a favorable predictor for a good long-term outcome. In practice, it is sometimes necessary due to patient preference or risk of definitive surgery to individualize care. Restricting this to research patients in unusual circumstances does not seem reasonable, provided the patient is informed of risks and follow-up is individualized to fit the circumstances.
Dr. Champagne: It also can be considered in elderly high-risk patients as long as they are compliant with aggressive surveillance.
Dr. J. Marks: Agree! This is a very exciting development and has real promise. That said, there is still a great deal to learn in its applicability. The major concern that I have is that this is being inappropriately applied to patients who are significant operative challenges. There is mucosal regression, but still a sizable cancer left in the wall and these patients are just being followed. We have seen too many patients who have had their treatment inappropriately delayed, with persistent, unrecognized cancer. I think this would be minimized if this was only done under protocol.
Dr. G. Marks: Agree. Following the published results of watchful waiting for the complete responder by the Habr-Gama group, there was a rush to embrace this revolutionary concept. I fear that this is driven by surgeons unable or disinclined to perform sphincter-preservation surgery for lowlying lesions. Recognizing the complete responder with any degree of certainty requires exceptional experience and advanced knowledge of the appearance of the neoadjuvant-treated rectal cancer.
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Accordingly, watchful waiting should be limited to IRB-approved study programs in centers with high volume.
sphincter-preserving surgery following neoadjuvant therapy where otherwise APR would be indicated.
Dr. DeNittis: Agree. Although there appears to be data supporting this approach, it certainly is not the standard of care. Clinical trials will ensure the proper similarities in patient selection and treatment techniques.
Dr. Saclarides: This statement is false for most patients who have acceptable operative risks. The decision as to which operation is best for such patients should be based on pretreatment tumor size, location and distance from the anus. Until more data are available, the decision should not be based on how much downstaging occurs with radiation and chemotherapy.
Dr. Nguyen: Agree. We do not yet have the modality that can evaluate with reasonable certainty a clinical complete response that correlates with pathologic complete response.
☛
Surgical decision making should always await tumor assessment following neoadjuvant therapy and a suitable interval.
Statement
Drs. Habr-Gama Definitely.
and
Perez:
Dr. DeNittis: Agree. There is a significant amount of new evidence to suggest that surgical decision making should be based on the neoadjuvant tumor response and not the pretreatment staging. The response may be predictive of outcome and patient-by-patient decision making is crucial. The patient who would otherwise be considered only a candidate for APR would frequently be considered for low anterior resection.
Dr. Nguyen: Agree. Regression of a large tumor that would have required an APR can be evident in four to 12 weeks following neoadjuvant therapy, possibly allowing for conversion to sphinctersparing surgery.
—Collleen Hutchinson is a health care communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached at colleen@ cmhadvisors.com.
Atrium’s full line of products for soft tissue repair empowers the surgeon to choose an appropriate implant with both mechanical durability and enhanced biocompatibility.
Dr. Champagne: Disagree. There are many cases when the appropriate surgical procedure (APR vs. colo-anal) can be determined after the office visit and pelvic magnetic resonance imaging. However, there also are some patients who are “borderline” and their ultimate fate can be better assessed after neoadjuvant therapy.
Dr. J. Marks: Agree. This is the only way the patient and surgeon can enjoy the full benefit of tumor down-staging. Although I would never advocate a minimal margin for a mid to upper rectal cancer after treatment, in the distal rectum, where sphincter preservation hangs in the balance, the advantages to this approach are obvious. Using this mindset, many centers, including our own, have been able to show a decrease in permanent colostomy rate from 25% to 40% to 10% or less.
Dr. Goldberg: Tumor assessment is critical to developing the proper strategy for managing patients after neoadjuvant therapy.
Dr. G. Marks: Agree emphatically. A small body of latecomers to neoadjuvant therapy, perhaps borrowing a page from the treatment of head and neck cancers, advocated that the selection of the surgical procedure be determined by the original presentation of the tumor rather than after neoadjuvant therapy. Nothing speaks so loudly as the strikingly improved results of local or radical
Handling. Healing. Reinforcement. TM
Find out more about Atrium’s hernia repair solutions at www.atriummed.com/biosurgery © Atrium Medical Corporation 2012. All rights reserved. Atrium, C-QUR Mesh, C-QUR V-Patch, C-QUR TacShield, C-QUR FX, C-QUR CentriFX, C-QUR Film, ProLite, ProLite Ultra and ProLoop are trademarks of Atrium Medical Corporation, a MAQUET GETINGE GROUP company.
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In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Study Reveals Laparoscopy Safe and Effective for GIST Removal B Y M ONICA S MITH SAN DIEGO—Most appropriately selected gastric gastrointestinal stromal tumors (GISTs) can be safely and effectively removed laparoscopically by general surgeons with basic laparoscopic skills, according to research presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES; S098). “Traditionally, gastric GISTs were approached through an open operation, like most intraabdominal neoplasms. However, these lesions have several characteristics that allowed early groups to consider approaching their removal via minimally invasive techniques,” said Michael Pucci, MD, chief general surgery resident, Thomas Jefferson University Hospital, Philadelphia. “GISTs do not require an extended resection margin or local lymphadenectomy to improve overall survival and many lesions grow in an exophytic manner. This unique combination of traits makes resecting these tumors via laparoscopy a favorable approach.” Since 2003, surgeons at Thomas
‘The authors introduced a useful classification system for these tumors to better define the role of laparoscopic resection in relation to tumor size and location.’ —Daniel J. Deziel, MD Jefferson University Hospital havee attempted laparoscopic resection as the first-line treatment for gastric GISTs measuring less than 7 cm at any position along the stomach. Their strategy for selecting gastriic GISTs for laparoscopic resectioon derives from imaging studies—up pper endoscopy with or without endoscopic ultrasound and views of the abdomen bdomen via computed tomography—to allow for appropriate preoperative planning. Dr. Pucci and his colleagues conducted a retrospective review of the institution’s experience to determine outcomes, derive a framework for selecting candidates for laparoscopic resection and give suggestions on approaching these tumors.
Zone classification system for gastrointestinal stromal tumors tumors.
One Institution’s Approach Based on the imaging results, surgeons at Thomas Jefferson University classify the tumors by zone according to their anatomic location. Zone I tumors are included in the area from the gastroesophageal (GE) junction to 3 cm distal
alongg the lesser curve to the angle of His. Zon ne II tumors make up the majority of GISTs and are located in the fundus G aand body of the stomach, and zone IIII tumors are found from the angularis incisura to the pylorus. The approach these surgeons are using is informed partly by whether u th he GIST is anterior or posterior to the stomach. Anterior tumors typically rrequire limited gastric mobilization and usually can be removed by simple wedgge resection using a linear GI anastomoosis stapler device. Posterior tumors require more extensive gastric mobilization tto fully evaluate the lesion. “Poosterior exophytic lesions may be amen nable to simple wedge resection, but posteerior intraluminal tumors will require an anterior an gastrotomy over the lesion,” Dr. Pucci said. “These tumors can then be delivered out of the stomach.” The gastrotomy will be closed with another firing of the linear stapler or absorbable sutures. Further surgical decisions are based on zone classification. Some zone I tumors at the GE junction require mobilization proximal to the fundus. Intraluminal zone I tumors require anterior fundus
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gastrotomy to fully expose the tumor in relation to the GE junction. “This tumor will then be delivered out of the stomach and resected via staple wedge resection,” Dr. Pucci said. At his institution, surgeons always use intraoperative endoscopy in zone I lesions to evaluate tumor location and assess patency of the GE junction after resection. Zone II tumors are the most amenable to gastric wedge resection via laparoscopy, and are handled based on whether they sit anterior or posterior to the stomach. Intraoperative endoscopy is used selectively in this group.
Zone III tumors can be a challenge to resect laparoscopically. “The goal of resection is to avoid narrowing the gastric outlet. Tumors within 1 cm will likely require distal gastrectomy with gastroenteric reconstruction, although some tumors may be amenable to gastric wedge resection,” Dr. Pucci said.
The Study’s Results Evaluating 104 gastric GIST resections since 2002, Dr. Pucci and his colleagues found 58 that were selected for laparoscopic resection. Only one resection converted to an open procedure—a case
involving a zone III tumor in which the gastric outlet had narrowed. This patient required a formal distal gastrectomy. Comparing the open group with the laparoscopic group, the team found tumor size significantly smaller in the laparoscopic group due to selection bias. Blood loss and hospital length of stay were significantly lower in the laparoscopic group as well. Histologic margins were negative in all of the laparoscopic cases. “When we subselect the laparoscopic group based on tumor zones, we observe some interesting trends,” Dr. Pucci said. “All five of the zone I tumors were
G
D
IN UC
IN
O TR
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successfully removed via standard wedge resection after anterior fundal gastrotomy. Intraoperative endoscopy always is used and is extremely beneficial with these lesions.” All 47 zone II tumors were successfully resected via stapled gastric wedge resection and were approached based on their location; intraoperative endoscopy was used in about 70% of these patients. Of the five zone III tumors, three were removed via gastric wedge resection. The other two required laparoscopic distal gastrectomy with gastroenteric reconstruction. Intraoperative endoscopy was not used in these cases. The researchers concluded that preoperative localization allows for optimal operative planning and maximizes the chance of successful laparoscopic removal, and that most small gastric GISTs can be removed by wedge resection with some variation of technique based on the anatomic location of the tumor. “Also, although some newer techniques are being developed to resect these tumors by other methods that require specialized training, our approach is something that most general surgeons [who are] comfortable with laparoscopy would be capable of doing without extra training,” Dr. Pucci said. The next step for Dr. Pucci and his colleagues is to look at the long-term oncologic outcomes of these patients to be sure they do not fare worse, for example, experience earlier recurrence than patients who undergo an open resection. “Our early outcomes have been promising,” Dr. Pucci said. Daniel J. Deziel, MD, Helen Shedd Keith Professor and chair of the Department of General Surgery, Rush University and senior attending surgeon, Rush University Medical Center, Chicago, considered the study a nicely sized series that confirms the ability of general surgeons to safely and effectively resect most gastric GISTs. “The authors introduced a useful classification system for these tumors to better define the role of laparoscopic resection in relation to tumor size and location, and potentially the limits of laparoscopic resection as well,” Dr. Deziel said. “I think it is important to consider this study and others in terms of predictors of unsuccessful laparoscopic resection for GIST or other gastric submucosal neoplasms.” As laparoscopic techniques extend to include a broader range of GISTs, another responsibility for surgeons is to make sure these methods continue to achieve adequate histologic margins, Dr. Deziel said, “and to ensure that the rate of leaks and other complications does not increase, especially in the most proximal and distal stomach, where the more difficult lesions are located.” Dr. Pucci has no financial disclosures.
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Opinion
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Obituary
The Metropolitan-Memorial Medical Center Patient Chart, 1902-2012 Pioneer in Medicine, Friend of Physician and Patient, Dies at 110
S
urrounded by family, friends, medical students and residents from all specialties, the patient Chart died peacefully at midnight on Feb. 29, 2012 at the Metropolitan-Memorial Medical Center. Chart was 110 years old. Born in February 1902, Chart spent her early years at the County Hospital for the Indigent. As the county hospital grew, it was renamed as the Metropolitan Hospital in 1928. With this growth, Chart played an integral role in the development of many medical advances in the city. She propelled countless staff members to positions of influence and fame as the city and its medical community grew. She served as the basic element of medical education as generations of medical students and residents analyzed her, interpreted her and used her to further their education. Additionally, Chart served as the basic unit of research, generating thousands of scientific papers that benefited thousands of patients. She fostered the careers of many prominent members of the medical staff. Chart grew up alongside her classmate, the Memorial Hospital. As Memorial grew into the Memorial Medical Center, Chart evolved from a few poorly organized pages into a well-developed chronology of patient disease and treatment. A fascinating and often contentious competition arose between the Charts as the two hospitals expanded and competed for patients and for medical recognition. In 1986, the Metropolitan Chart married the Memorial Chart in a much-publicized Chart wedding. Now known as the MetropolitanMemorial Medical Center Chart, a period of rapid growth ensued. This growth led to Chart’s expansion and refinement. Chart was now divided into easily accessible physician orders, progress notes, laboratory data, nurses’ notes, medications and subpoenas. When interviewed in 1996, one enterprising reporter asked about Chart’s much discussed increasing girth. The reply, in the good-natured manner that became her hallmark, was: “Too many consultants, too many tests and too many note-happy medical students!” Chart had several children, most notably in the Progress note wing of the family. Chart’s oldest son, Illegible, was dismissed from the hospital staff in 1990. Other children—Meaningless, Incomprehensible and Puzzling remained up until the mid-2000s.
Chart was most proud of her other children— Insightful, Helpful and Stunningly Brilliant. They survive and continue to maintain a strong presence at the medical center. She leaves behind a rich legacy of medical progress interlaced with crystalline insight and occasional humor. Chart’s two stepdaughters, Agree with Above and Agree with Below, delivered moving eulogies at the recent medical center memorial service. Dr. Ralph Eggerton III, president of the Metropolitan-Memorial Medical Center Emeritus Society, said: “We shall always remember Chart. We will remember the many notes that reflect not only the patient’s disease and progress, but also the spirit and personality of the physicians who delivered such great care to so many patients for so many years. The physicians and students recorded that care in a distinctly unique manner. Just as a novel has its own plot, character development, intrigue, suspense and surprises, so did
Chart reflect the same elements, but in the context of human disease and recovery.” Chart was preceded in death by her life-partner Index Medicus who died in 2004. The Metropolitan-Memorial Medical Center Chart is survived by her only remaining relative, the Metropolitan-Memorial Medical Center Electronic Medical Record. The Electronic Medical Record was scheduled to speak at Chart’s memorial service, but was the unfortunate victim of an error message and could not attend. A second memorial service will be held at the Wilmington Shredding Company at 4 PM on Thursday, May 24, 2012. The Chart family requests that in lieu of flowers, memorial contributions be made to the Metropolitan-Memorial Medical Center Medical Library. —Leo A. Gordon, MD Los Angeles, Calif.
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9LVLW www.RECOTHROM.com RU VFDQ WKH 45 FRGH ZLWK \RXU VPDU WSKRQH
RECOTHROM is a registered trademark of ZymoGenetics, Inc. ‹ =\PR*HQHWLFV ,QF $OO ULJKWV UHVHUYHG 57
7KURPELQ PDGH ZLWK D WZLVW RECOTHROM is human thrombin produced using recombinant DNA technology ² ,Q D JHQHWLFDOO\ PRGLÀHG &+2 &KLQHVH KDPVWHU RYDU\ FHOO OLQH Q 1RW GHULYHG IURP FDWWOH RU KXPDQ SODVPD Q &RQYHQLHQW DQG HDV\ WR XVH ² 5(&27+520 &RQYHQLHQFH .LWV DOORZ IRU TXLFN DQG HDV\ UHFRQVWLWXWLRQ Q )OH[LEOH SURGXFW OLQH ZLWK PXOWLSOH DSSOLFDWLRQ PHWKRGV ² 0D\ EH DSSOLHG GLUHFWO\ RU LQ FRQMXQFWLRQ ZLWK DEVRUEDEOH JHODWLQ VSRQJH 863
INDICATION RECOTHROM Thrombin, topical (Recombinant) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. IMPORTANT SAFETY INFORMATION Contraindications ‡ Topical use only – DO NOT INJECT directly into the circulatory system ‡ Do not use for the treatment of massive or brisk arterial bleeding ‡ Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins Warnings and Precautions ‡ Potential risk of thrombosis if absorbed systemically ‡ In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction Adverse Reactions ‡ 7 KH VHULRXV DGYHUVH HYHQW WKDW RFFXUUHG LQ • Q RI SDWLHQWV H[SRVHG WR 5(&27+520 LQ FRPSOHWHG FOLQLFDO WULDOV ZDV DWULDO žEULOODWLRQ 7KH PRVW FRPPRQ DGYHUVH HYHQWV UHSRUWHG LQ WKHVH WULDOV 1 ZHUH LQFLVLRQ VLWH SDLQ SURFHGXUDO SDLQ DQG QDXVHD $GYHUVH HYHQWV UHSRUWHG LQ WKHVH WULDOV were consistent with those commonly observed in surgical patients Please see Brief Summary of Full Prescribing Information on following page.
18
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Inguinal Hernia Repairs on the Decline in Midwest, Study Shows B Y C HRISTINA F RANGOU NEW YORK K—The number of inguinal hernia repairs performed annually has fallen steadily over the past two decades in Minnesota, according to a new study presented at the Fifth International Hernia Congress. The change is most likely due to the advent of laparoscopic and mesh-based repairs. These technical developments are
thought to explain the increase in bilateral repair, and a subsequent decrease in recurrent and contralateral hernia repair. “Inguinal hernia repairs are common, but several [technical advances] are happening that have changed their incidence,” said lead author Benjamin Zendejas-Mummert, MD, general surgery resident at Mayo Clinic, Rochester, Minn. The study is based on data from the Rochester Epidemiology Project, a
database that tracks medical records for all residents of Olmsted County, Minn. The county has a high percentage of medical professionals, is 90% white and 11% of its population is older than age 65 years. Its population is fairly representative of the Midwestern United States, but does not represent the rest of the country because minorities, such as Hispanics and blacks, are underrepresented. Still, the study provides an interesting snapshot of how changes in technique
Immunogenicity The potential development of antibodies to RECOTHROM has been evaluated in multiple clinical trials. These pre-specified evaluations were performed in order to characterize the immunogenicity of RECOTHROM and the neutralizing potential of any detected antibodies. In completed clinical studies 5 of 552 (0.9%) patients exposed to RECOTHROM with both baseline and post-treatment antibody specimens available developed specific anti-RECOTHROM product antibodies. None of these antibodies were found to neutralize native human thrombin. BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION RECOTHROM® Thrombin, topical (Recombinant) Rx Only The following is a brief summary of the full prescribing information for RECOTHROM Thrombin, topical (Recombinant). CONTRAINDICATIONS Do not inject directly into the circulatory system. Do not use for the treatment of massive or brisk arterial bleeding. Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM, or hamster proteins. WARNINGS AND PRECAUTIONS Potential risk of thrombosis if absorbed systemically. In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction. ADVERSE REACTIONS The serious adverse event that occurred in ≥ 1% (n=6/583) of patients exposed to RECOTHROM in completed clinical trials was atrial fibrillation. The most common adverse events in patients exposed to RECOTHROM in clinical trials (N=583) were incision site pain (51%), procedural pain (30%), and nausea (28%). Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical trials have been performed with RECOTHROM applied with absorbable gelatin sponge (Phase 2, Phase 3, and Phase 3b studies) and applied with a spray applicator (Phase 2 study). Adverse events reported in clinical trials were consistent with those commonly observed in surgical patients. Clinical Trials of RECOTHROM Used in Conjunction with Gelatin Sponge Among the 411 patients treated with study drug in the randomized, double-blind, Phase 3 study that compared RECOTHROM to bovine thrombin, both applied with gelatin sponge, in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, all but 2 patients (1 patient/treatment group) reported adverse events. Most events were moderate in severity and had a similar incidence in the RECOTHROM and bovine thrombin treatment groups. The most common adverse events were incision site pain (63% for both treatment groups), procedural pain (RECOTHROM 29%; bovine thrombin 34%), and nausea (RECOTHROM 28%; bovine thrombin 35%). Serious adverse events were reported by 18% of patients treated with RECOTHROM and 22% with bovine thrombin.
In the randomized, double-blind, Phase 3 study that compared RECOTHROM to bovine thrombin, both applied with gelatin sponge, in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, the development of specific anti-product antibodies was evaluated in both treatment groups. Blood samples were collected at baseline and at day 29 for 97% of the patients in both treatment groups. For patients randomized to RECOTHROM, the samples were analyzed by ELISA for antibodies to RECOTHROM, Chinese hamster ovary (CHO) host cell protein, and pro-thrombin activator (used in the conversion of single chain precursor to active RECOTHROM). For patients randomized to bovine thrombin, the samples were analyzed by ELISA for antibodies to bovine thrombin product. At baseline 1.5% of patients (n=3/198) in the RECOTHROM group had positive anti-product antibody titers compared with 5% of patients in the bovine thrombin group (n=10/200). Of the patients who had detectable anti-product antibodies at baseline, 0 of 3 in the RECOTHROM group and 8 of 10 in the bovine thrombin group exhibited ≥ 1.0 titer unit (≥ 10-fold) increases in antibody levels after study treatment. Treatment with RECOTHROM applied with absorbable gelatin sponge resulted in a statistically significantly lower incidence of specific anti-product antibody development. Three of 198 (1.5%; 95% CI, 0 to 4%) of the patients in the RECOTHROM arm developed specific anti-thrombin product antibodies (1 patient also developed anti-CHO host cell protein antibodies). No patients developed antibodies to pro-thrombin activator. Forty-three of 200 patients (22%; 95% CI, 16 to 28%) in the bovine thrombin arm developed specific antibodies to bovine thrombin product. None of the antibodies in the RECOTHROM group neutralized native human thrombin. Antibodies against bovine thrombin product were not tested for neutralization of native human thrombin. Because the study was not powered to detect a difference in clinical outcomes attributable to antibody formation, no conclusions can be drawn regarding the clinical significance of the difference in antibody formation based on the results of this study. In the open-label, single group, Phase 3b study in patients with a high likelihood of prior bovine thrombin exposure undergoing spinal, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, 15.6% of patients (n=32/205) had anti-bovine thrombin product antibodies at baseline prior to treatment with RECOTHROM. Following treatment, none of the 200 evaluable patients (patients for whom specimens were available for antibody testing at baseline and post-RECOTHROM treatment) developed antibodies to RECOTHROM. In the randomized, double-blind, controlled Phase 2 studies of RECOTHROM compared to placebo (RECOTHROM excipients reconstituted with 0.9% sodium chloride, USP) applied in conjunction with absorbable gelatin sponge, which were performed across a range of surgical settings (spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access), the incidence of antibody development to RECOTHROM was 1.2% in the RECOTHROM group (n=1/83) compared to 2.4% (n=1/41) in the placebo group. In the open-label, single group Phase 2 study of RECOTHROM applied with the spray applicator to excised burn wounds, 1 patient developed antibodies following treatment (1.6%, n=1/62).
Adverse events of interest were pre-specified, based on the thrombin mechanism of action, use of absorbable gelatin sponge, USP, historical reporting in association with cross-reacting antibodies to bovine thrombin product, and results from Phase 2 clinical trials of RECOTHROM applied with absorbable gelatin sponge. The incidences of these pre-specified adverse events were similar between treatment groups (see Table 1).
The detection of antibody formation is highly dependent upon the sensitivity and specificity of the assay. The absolute immunogenicity rates reported here are difficult to compare with results from studies of other products due to differences in assay methodology, patient populations, and other underlying factors.
Table 1. Events of Interest in the RECOTHROM Phase 3 Study
To report p SUSPECTED ADVERSE REACTIONS,, contact ZymoGenetics, y , Inc. at 1-888-784-7662,, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. g
AE Category* Patients with any event category Bleeding Cardiac Hypersensitivity Nausea + vomiting Other infection Post-operative wound infection Thromboembolic
RECOTHROM (N=205) n (%) 124 (60%) 27 (13%) 41 (20%) 30 (15%) 68 (33%) 26 (13%) 19 (9%) 12 (6%)
†
Thrombin-JMI (N=206) n (%) 136 (66%) 24 (12%) 38 (18%) 37 (18%) 83 (40%) 31 (15%) 22 (11%) 10 (5%)
*
Adverse events were included in event categories based on a blinded review of the investigator verbatim and coded terms. † THROMBIN-JMI® Thrombin, Topical (Bovine). In an open-label, single-group Phase 3b study, 209 patients with documented or highly likely prior exposure to bovine thrombin within the previous 3 years were treated with RECOTHROM when undergoing surgeries (spinal or peripheral arterial bypass or arteriovenous graft formation for hemodialysis access). The most common adverse events were incision site pain (45%), procedural pain (39%), and nausea (27%). Similar to the Phase 3 study, serious adverse events were reported by 22% of patients treated with RECOTHROM. Clinical Trials of RECOTHROM Applied with Spray Applicator In an open-label, single-group, Phase 2 study in burn patients, 72 patients were treated with RECOTHROM applied with a spray applicator at the burn wound excision site prior to autologous skin grafting. This study included both adults (≥ 17 years of age, n=68) and pediatric patients ≤ 16 years of age (n=4). The most common adverse events in the adult and pediatric age groups included procedural pain (35%), pruritis (25%), and constipation (19%).
DRUG INTERACTIONS Drug interactions have not been formally studied. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with RECOTHROM. It is also not known whether RECOTHROM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RECOTHROM should be given to a pregnant woman only if clearly needed. Pediatric Use Of the 72 patients undergoing burn wound excision and grafting treated with RECOTHROM applied with the spray applicator in the open-label, single group, Phase 2 study, 4 were pediatric patients. All were age 12 to 16 years. The safety and effectiveness of RECOTHROM in all pediatric age groups have not been fully established. Geriatric Use Of the total number of patients in Phase 2 and Phase 3 clinical studies of RECOTHROM with absorbable gelatin sponge, 38% were 65 years old and over, while 16% were 75 years old and over. No substantive 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. For Full Prescribing Information, access www.RECOTHROM.com Manufactured for ZymoGenetics, Inc. RT022-06, January 2011
are affecting hernia repair rates. Analysis showed that the incidence of inguinal hernia repair dropped for both men and women between 1989 and 2008. In men, inguinal hernia repair rates fell by 21%, including a 22% reduction in unilateral hernias. Among women, repair rates fell by 61% (Table). Over the same period, hernia repair techniques underwent a revolution. Open non-mesh repairs accounted for more than 90% of repairs in 1989 but fell to a mere 4% two decades later, whereas mesh and laparoscopic techniques increased in popularity. Over the same time period, open mesh repair rose from less than 10% to 55% by 2000, and remained steadily at that mark until 2009. As use of mesh escalated, surgeons increasingly employed laparoscopic techniques to perform the repairs. Laparoscopic hernia repairs in the area began in 1992. The technique quickly took off, accounting for 15% to 20% of cases between 1996 and 2000. By 2008, 41% of all inguinal hernia repairs were done laparoscopically. Other estimates suggest that about 25% of hernia repairs are conducted laparoscopically.
‘If the cumulative incidence for inguinal hernia repair in men is 42%, then the actual incidence of inguinal hernia must be higher. It must be far greater than 50%. That’s far, far higher than most published reports.’ —Robert J. Fitzgibbons, MD Laparoscopic repair makes it easier for surgeons to detect asymptomatic contralateral inguinal hernias, leading to higher rates of bilateral repair and, as a result,, lowe lower werr ra we rrates tess of subsequent con ont ntr t al tral alat ater at e aall rep er epai aiir.. The sttud udyy co confi nfi nfi firrms m tha hat pa p tt teern; rn n; bi bila late la tera te rall re ra repa p ir irss in incr crea cr ease ea seed betw be tw wee een n 19 1989 899 and n 2009 20 09,, up 09 p 70% in me men n and an d 48 488% 8% in wo wom m n. men. me
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Table. Inguinal Hernia Repair from 1989 to 2009: By the Numbers Type of Repair
1989
2008
Open non-mesh
90% of all repairs
4% of all repairs
Open mesh
10% of all repairs
55% of all repairs
Laparoscopic Type of Repair
41% of all repairs 1989-2008/2009
Inguinal herniain men
Decreased by 21%
Inguinal hernia in women
Decreased by 61%
Bilateral in men
Increased by 70%
Bilateral in women
Increased by 488%
“In other words, by fixing more hernias up front with a laparoscopic approach, we are likely decreasing the need for a repeat hernia operation on the opposite side down the road,” said Dr. Zendejas-Mummert. The study also showed that men’s risk for inguinal hernia peaks between ages 70 and 79, with an incidence of 922.6 per 100,000 person-years. For women, the highest incidence occurs in their 80s at 148.1 per 100,000 person-years. Additionally, 42% of men who live to age 90 years will undergo an inguinal hernia repair. According to the study, obesity is associated with lower rates of inguinal hernia repair but the reason is unknown. Among men, repair rates peak sharply among those with a body mass index (BMI) between 22 and 28 kg/m2. When BMI hits 30 kg/m2, repair rates quickly decline. There are several potential explanations for the finding, said Dr. Zendejas-Mummert. Abdominal fat may be protective by occluding at potential hernia sites or hernias may be more difficult to detect in obese individuals. It also could be that obese individuals have other health care priorities that take precedence over having an inguinal hernia repaired. What’ss most striking in the study is What the high rate of laparoscopy adoption (41%)) an (4 aand nd th thee h high g ccumulative gh u ul um ulative incidence forr meen, sai fo aid d Ro Robe bert be rtt J. Fitzgibbons, MD,, Ha MD H rr rr y E E. Stu tuck cken ck enho en hoff Profesho sorr of Sur so urge gery ge ryy and n chi hief ef of ge general surgery ge ry at Cr C ei eigh ghtttoon Un gh U iv iver ersi er sity si ty Sch hoool of Medi Me dici di cine ci ne,, Om ne Omaaah ha, a Neb eb.. “I “Iff th thee cu c mu mula lala a tiive inc ncid iden id ence en ce for ing ngui u na ui n l
hernia repair in men is 42%, then the actual incidence of inguinal hernia must be higher. It must be far greater than 50%. That’s far, far higher than most published reports.” Two other factors also may influence the rate of inguinal hernia repair—watchful waiting and the increasing BMI of Americans. Watchful waiting grew as a concept over the past 20 years, but it is unknown how many surgeons and patients wait before
electing to operate. Dr. Fitzgibbons, one of the authorities on watchful waiting in the United States, said the strategy likely tempers the rate of repairs. The authors stressed that the results are not generalizable throughout the United States. Although the changes in hernia repair techniques have spread across the country, it’s likely that national adoption of laparoscopy lags behind Olmsted County and Mayo Clinic.
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20
On the Spot
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Gut Reaction: Metabolic and Bariatric Surgery (Part 2 of 2) See June 2012, page 28, for Part 1 Contributor
Jaime Ponce, MD Dalton, Ga.
Robin Blackstone, MD Scottsdale, Ariz.
Walter Pories, MD Greenville, N.C.
Manuel GalvaoNeto, MD Sao Paulo, Brazil
Emma Patterson, MD Portland, Ore.
Dan Jones, MD Boston, Mass.
Raul Rosenthal, MD Weston, Fla.
Aurora Pryor, MD Stony Brook, N.Y.
Natan Zundel, MD Miami, Fla.
Single-port access
Not needed in most bariatric cases; unproven benefit
Why bother?
Not a major breakthrough
Feasible, cosmetic, technically demanding
It reminds me of hand-assisted surgery, and is industry-driven
Potential current and iatrogenic burns; Fundamental Use of Surgical Energy (FUSE)
Funny; Needs a partner
More work, better cosmesis; Great for some patients
No real advantage today, except cosmesis; Can be safely performed in very selected patients; Should not be routinely performed today
Metabolic surgery
Cure metabolic diseases with surgical changes in hormonal interactions that also produce weight loss
The key to the future
A good and correct name but hasn’t caught on; we need a better name
It is a reality with very supportive data and is here to stay, benefiting even more people than bariatric surgery
Will save many lives
Improves health
Work in progress
Appropriate; ready to have it covered in the United States
Buchwald and Varco’s definition in their book: “The operative manipulation of a normal organ or organ system to achieve a biological result for a potential health gain”
Diabetes surgery
Cure diabetes with changes in hormones interactions without necessarily a weight loss effect
Part of the answer; a window into the mystery of diabetes
Also a good name but the effects are far wider than the remission of diabetes
Same as metabolic surgery
We need to intervene earlier
Makes economic sense, too
Been done for the last 50 years
An important component of bariatric practice
From insulin pumps to pancreatic transplantation; do we have a bariatric/metabolic/diabetes operation(s) deserving of inclusion in that group? I think we do. We just need to define/ study and prove it better.
Open surgery in bariatrics is
Outdated and rarely needed
Rarely performed if ever for primary procedures and needed less often for secondary procedures
A last choice but may be an essential choice for some patients
Dead
Ancient history
Reasonable in super obesity
Last resort if complications ensue
Hopefully a rarity
Accepted as long as it’s performed well. Time/ experience/results will reduce the number of “open” surgeons and procedures, like we saw with cholecystectomies and others.
Staple-line reinforcement
Most of the time not needed
Have been able to achieve a low bleeding and leak rate without it
Promising
Use in most of my sleeve gastrectomy cases
I use them only on the proximal three staple lines of a sleeve because it’s the standard of care.
OK
Optional
A good night’s sleep
My preference: Oversew with a running suture
My fellows/ residents need to learn
Patience
N/A
How to talk to and examine patients
Therapeutic digestive endoscopy
To do a good history and physical exam, and be gentle with the tissues in surgery
Endoscopy
To have second thoughts
Efficient suturing
More about life and what it really means to be a surgeon, and teamwork
Worst case I Redo case x 4 ever had was (bypass, reversal, band, etc.) with erosion and a leak
The complication I am dealing with at the time…. shouldn’t we be able to do this complication-free?
Fatal pancreatitis following a tooaggressive attempt to retrieve common duct stones
Sleeve gastrectomy with angle of His leaks
Completed disrupted GJ anastomosis after a reoperative gastric bypass
Acute negative A fatal pulmonary pressure pulmonary embolism edema
Steroid-treated tissues that wouldn’t hold sutures
Most of my weight loss failures for bad surgery selection
Patient marketing in bariatrics
Can be used but should be truthful, not misleading
Direct-to-consumer should be outlawed
Could be a lot better; we need to address this important issue
Your good practice is your best marketing tool. Broad and unbiased marketing campaigns will benefit all
Is fine as long as done ethically
1-800-GET-THIN. Not!
Not good
An unfortunate necessity
I do not use it, but I am not against it as long as it adheres to the guidelines and regulations published by the ASMBS and other societies.
Insurance companies =
Needed headache!
Could be a pivotal force to change the management of obesity by working closely with the society to improve access in a responsible way
Have been more supportive than expected; we have been remiss in not communicating more effectively
Will have to deal in Are the rich middlea more serious and man in medicine professional way with the obesity and metabolic issue regarding surgical treatment
Better patient coverage with less physician reimbursement
Should have offices in every mall
Enabler and road block
We need to work closer with them to make sure that processes and approvals are not influenced by non-medical factors.
On the Spot
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
On the Spot’s Gut Reaction by Colleen Hutchinson Christine RenFielding, MD New York, N.Y.
Alfons Pomp, MD New York, N.Y.
Yes, unless long torso, or limited technical skills/ instruments
Kelvin Higa, MD Fresno, Calif.
John Morton, MD Stanford, Calif.
Jeff Allen, MD Louisville, Ky.
Marina Kurian, MD New York, N.Y.
Dan Herron, MD New York, N.Y.
Ricardo Cohen, MD Sao Paulo, Brazil
Michel Gagner, MD Montreal, Canada
Colleen Hutchinson
Marketing gimmick Finally, a purpose in bariatrics for the robot
For the obese patient? Really?
Not sold on the benefits
I do it; am concerned about umbilical hernia rate which is higher than seen in standard lap cholecystectomy, for example.
Marketing tool in most cases; little morbidity is caused by adding 1, 2, 3, or even 4, 5mm trocars.
What’s the purpose?
Spider technology
Jaime, thank you for your candor.
Name still not widely accepted
Should be the new name for bariatrics
What we do
Its effects are wide- A continually spread and proexpanding field vide a platform for understanding the human condition
The results need to be better than existing operations to improve co-morbidities. Currently none of them have better results than bypass and DS
Hopefully will Here to stay soon be recognized by insurers as the most effective therapy for T2DM and metabolic syndrome
Yes, sleeve first
Robin says it best; Walter makes a good point on name.
Better. Yes.
Should be metabolic surgery
Amazing, isn’t it?
Is underused; it is safe and effective; the time is now for patients to get needed treatment
Controversial in the bariatric community, but we offer the best chance for remission
Patients need to be carefully selected and C-peptide should be one of the tests to help identify an appropriate operation
Ditto
I prefer metabolic surgery. Diabetes is a part of metabolic syndrome
Yes, sleeve first
Miracle
Necessary only in Still necessary select cases, most- sometimes ly for adhesions
Obsolete
For revisions and historic
Necessary at times and should not be viewed as a weakness
Never going to be Still valuable in extinct; sometimes complex revisionyou just need to get al cases. your hands in there!
Rarely needed
Gone with the wind
Hopefully still taught
Suture imbrication
I use it because it works; there is no EBM on this though
Too expensive
Not generally required
Likely decreases bleeding, but not much else
Absolutely in certain cases and scenarios
No good data to support lower leak rates or clinically significant reduction in bleeding
I like it. In sleeves
Always
Definintely no consensus here
Active watching
Not every obese patient is a candidate for surgery
Nothing. They already know everything they need to, they just need some help putting it all together.
From their patients; listen to patients
Availability, affability, ability
That the end of the case is as important as the beginning.
How to handle challenging medical, technological, political and interpersonal problems in a medicolegal environment
How tough it is to be a metabolic surgeon; we must study a lot
When not to operate (wisdom)
Obedience (they’re ages 3 and 5)
90% dead stomach Any major from acute gastric complication dilatation
Yesterday
Jehovah’s Witness who bled postop but stopped and lived!
Marginal ulcer eroding into splenic artery
When you do everything right yet the patient has no reserve and things spiral out of your control despite your most intense efforts
My first weekend on call as an attending! Mystery sepsis after gastric bypass on a patient I was covering. (Patient did well!)
Revisional surgery of experimental non-approved procedures
Any leak
Morton might win here.
Is a big target for criticism by those who do not believe that obesity is a disease
Needs to be regulated!
Distasteful, but necessary
Approach with education first and caution in mind
Too prevalent in many markets
I have no problem with it but be prepared to back up the claims with proof: Are you really the best?
Sometimes a valuable service for patients, sometimes not
A way to spread how useful metabolic surgery is…
Needs more regulation (public protection)
Dicey
Expensive to both the patient and physician
Bah humbug!
The antichrist
Should be our partners; our interests are aligned in improving health and decreasing cost; we can add value to health care.
Hopefully some have seen the light
Need to be made not for profit so the needs of the people can be met
Shareholders first, patients second
Should better balance the advantages of metabolic surgery
Discriminate
A force to contend with
21
22
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Post-op Cognitive Complications in Elderly May Increase Mortality B Y J OHN S CHIESZER SEATTLE—Postoperative cognitive complications (POCC) appear to be associated with significantly increased inpatient mortality, facility discharge, hospital length of stay (LOS) and costs, according to a study presented at the American Geriatrics Society’s 2012 annual scientific meeting (abstract 163). “We think physicians should care
about these findings because understanding the burden of and risk factors for postoperative cognitive complications is important,” said study investigator Mary Erslon, RN, MSN, manager of health care policy at Covidien, Mansfield, Mass. “Identifying these high-risk patients may allow for appropriate early intervention.” POCC commonly occurs in elderly patients following surgery. However, the burden of these complications is difficult
to assess because there is no standard way to determine or document POCC. To this end, Ms. Erslon and her colleagues used a large administrative database to assess the incidence, risk factors and patient outcomes associated with POCC in elderly patients in the top five major diagnostic categories (MDC): nervous system; eye; ear nose and throat; respiratory system; and circulatory system. The researchers selected the inpatient surgical discharges in the top five MDCs
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‘We think physicians should care about these findings because understanding the burden of and risk factors for postoperative cognitive complications is important.’ —Mary Erslon, RN, MSN
for patients older than age 50 years from the Premier Perspective Database for the 2010 calendar year. They determined incidence and estimated the adjusted risk for POCC based on age, admitting status, general anesthesia, LOS in the intensive care unit (ICU), comorbidity and MDC type, using circulatory system surgeries as a reference. The primary goal of the study was to compare mortality, LOS, costs and discharge disposition between patients who had POCC and those who did not. The investigators selected 576,821 inpatient surgical discharges, 6,553 (1.1%) of which were coded for POCC. The researchers found that the risk for POCC increased with age by 311% for those aged 85 years and older, ICU stay by 183% and nonelective admission by 94%. They also found that compared with circulatory system surgeries, musculoskeletal surgeries increased the risk for POCC by 158%, digestive system surgeries by 86%, nervous system surgeries by 48% and hepatobiliary/pancreatic surgeries by 46%. Additionally, the mean LOS for patients with POCC almost doubled (10.8 vs. five days for patients without POCC). In-hospital death occurred in 4.9% of patients with POCC compared with 1.4% of patients without POCC. Patients with POCC also were almost
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Table. Factors for Increased Risk for Postoperative Cognitive Complications (POCC) in Elderly Factor
Risk Increase, %
Age 85+ years
311
ICU stay
183
Nonelective admission
94
Musculoskeletal operationsa
158
Digestive system operationsa
86
Nervous system operations
a
a
48
Percentages are based on comparison with circulatory system surgeries.
‘This is a patient population that needs to be identified and understanding or managing these postoperative complications could lead to improved outcomes.’
of medicine and occupational therapy and director of the Long Term Care Research Consortium in the Department of Geriatrics and Nutritional Sciences at Washington University School of Medicine, St. Louis, said POCC is a very important problem and studies like this are valuable. “As the population ages, the number of cases and the burden of care related to POCC will increase dramatically. More studies are needed to identify risk factors for POCC among subpopulations of hospitalized patients, and to identify interventions that will reduce the incidence of POCC, shorten
the duration of symptoms and reduce the risk of nursing home placement,� Dr. Binder told General Surgery News. John Morley, MD, director of the Division of Geriatric Medicine and Dammert Professor of Gerontology at Saint Louis University School of Medicine, in St. Louis, said this study confirms his belief that all older patients should be screened. “Some people may be at higher risk for delirium. People need to be followed very carefully following surgery.� Dr. Morley added, “There are a lot of things we can do to prevent these patients from having poor outcomes.�
Experience Performance.
—Mary Erslon, RN, MSN three times more likely to be discharged to a facility than patients without POCC (61.5% vs. 25.6%). The mean total cost of care was $33,395 for patients with POCC compared with $19,730 for patients without POCC. “We defined the problem of postoperative cognitive complications very strictly. We did not use the general clinical practice definition; we used a much stricter definition. By identifying them in this way we chose the patients who have the most severe postoperative cognitive complications,� said Ms. Erslon in an interview with General Surgery News. “This is a patient population that needs to be identified, and understanding or managing these postoperative complications could lead to improved outcomes.� Ellen Binder, MD, associate professor
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23
24
Surgeons’ Lounge
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Dear Readers, Welcome to the July issue of The Surgeons’ Lounge. With this issue, we resume the regular format for The Surgeons’ Lounge. I hope our readers enjoyed the last two issues, which covered the colorectal surgery and foregut symposia, in Fort Lauderdale, Fla. This issue features David Hazzan, MD, director of minimally invasive surgery, Carmel Medical Center in Haifa, Israel, who will be discussing the case of epiphrenic diverticula. We have included some interesting feedback and correspondence from our readers as well. We thank you for taking the time to communicate your thoughts and comments. We greatly value our readers’ opinions and encourage feedback. Sincerely, Samuel Szomstein, MD, FACS Dr. Szomstein n is associate director, Editor, The Surgeons’ Lounge Bariatric Institute, Section of Minimally Invasive Surgery, Department of General Szomsts@ccf.org and Vascular Surgery, Cleveland Clinic Florida, Weston.
Question for Dr. Hazzan From Tamar Abramovich, MD Department of Surgery B, Carmel Medical Center, Haifa, Israel
A
68-year-old woman had a history of regurgitation, halitosis and recurrent aspirations over the past few years. She underwent a barium swallow that revealed epiphrenic esophageal diverticula. What is your preferred workup for this patient? Do you always perform a preoperative manometry? Are asymptomatic patients candidates for surgery? What is the likelihood of malignancy in the diverticula? What is your preferred surgical approach?
Figure. Epiphrenic esophageal diverticula seen on barium swallow.
Dr. Hazzan’s
Reply
Epiphrenic diverticula are found adjacent to the diaphragm in the distal third of the esophagus. They are false diverticula that often are related to achalasia and diffuse esophageal spasm. They most often are related to thickened esophageal musculature or increased intraluminal pressure. A barium swallow is the best diagnostic tool to detect the presence of
epiphrenic diverticula. The size, position and proximity of the diverticula to the diaphragm can be clearly delineated. The underlying motility disorder often is identified as well; however, manometric studies need to be undertaken to evaluate the overall motility of the esophageal body and lower esophageal sphincter. An endoscopy is always performed to detect mucosal lesions, including esophagitis, Barrett’s esophagus and distal cancer. Treatment is recommended for patients who have moderate to severe symptoms. There is no consensus as to whether asymptomatic patients should
undergo treatment as well. Despite the finding that asymptomatic patients do not usually develop symptoms during many years of follow-up, the fact that minimally invasive approaches are available for the management of epiphrenic diverticula may make surgical therapy more appealing. The incidence of cancer in an epiphrenic diverticulum is less than 1%. Risk factors for malignancy are advanced age, male gender, longstanding history of cancer and larger diverticula. Outcomes usually are quoted as dismal because of a delayed diagnosis but several cases of superficial carcinoma have been described. In this particular case, because the diverticulum is wide-mouthed, I would perform a diverticulectomy, contralateral myotomy and Toupet fundoplication. In some cases when the diverticulum is small, surgeons might recommend diverticulopexy to prevent creating a stapler line that is at risk for leakage. In both cases, a long esophageal myotomy is a crucial step in the treatment of this pathology. The extent of the myotomy is an issue of debate: Most authors recommend d starting t ti from f the th level l l off the th base of the diverticulum and extending the myotomy 1 to 2 cm distal to the esophagogastric junction. For many decades, the traditional approach was through a left thoracotomy; more recently, minimally invasive techniques by video-assisted thoracic surgery or laparoscopy have been used successfully and are now the procedures of choice in most cases. I strongly believe that the laparoscopic approach is ideal for the treatment of this pathology. The esophageal hiatus is approached, the distal esophagus is mobilized and the diverticula is identified and cleared of surrounding tissue to expose the mucosa at the
neck of the diverticula. After inserting a 56 to 60 Fr bougie down through the esophagus, a linear cutting stapler is used to excise the diverticula. The overlying muscle is closed. A myotomy is then performed on the opposite side of the esophagus, the hiatus is closed and a partial fundoplication— either Dor or Toupet—is performed. The postoperative morbidity should be less than 5%. Most patients can be discharged by postoperative day 2 and the long-term results in terms of dysphagia or reflux are similar to those of patients after Heller myotomy due to achalasia.
Suggested Reading 1.
2.
3.
4.
5.
6.
7.
8.
Vicentine FP, Herbella FA, Silva LC, Patti MG. High resolution manometry findings in patients with esophageal epiphrenic diverticula. Am Surg. 2011;77:1661-1664. Fisichella PM, Pittman M, Kuo PC. Laparoscopic treatment of epiphrenic diverticula: preoperative evaluation and surgical technique. How I do it. J Gastrointest Surg.. 2011;15:1866-1871. Zaninotto G et al. Therapeutic strategies for epiphrenic diverticula: systematic review. World J Surg. 2011;35:1447-1453. Rosati R et al. Long-term results of minimally invasive surgery for symptomatic epiphrenic diverticulum. Am J Surg. Surg 2011;201:132-135. D’Journo XB et al. Lower oesophageal sphincter dysfunction is part of the functional abnormality in epiphrenic diverticulum. Br J Surg. 2009;96:892-900. Melman L et al. Esophageal manometric characteristics and outcomes for laparoscopic esophageal diverticulectomy, myotomy, and partial fundoplication for epiphrenic diverticula. Surg Endosc. 2009;23:1337-1341. Varghese TK Jr et al. Surgical treatment of epiphrenic diverticula: a 30-year experience. Ann Thorac Surg. 2007;84:1801-1809. Reznik SI et al. Assessment of a pathophysiology-directed treatment for symptomatic epiphrenic diverticulum Dis Esophagus. 2007;20:320-327.
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Surgeons’ Lounge DIVERTICULA
jcontinued from page 24
Correspondence From David A. Pardieck, MD, Charleston, S.C. Re: Gallbladder case presented in The Surgeons' Lounge, April 2012 The case was about a 27-year-old man who presented with classic symptoms of acute cholecystitis. The confirmative tests included ultrasonography of the right upper quadrant, which showed
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
multiple stones in the gallbladder. The description didn’t mention this, but I would assume the test also showed a thickened gallbladder with distention. Then there was mention that a magnetic resonance cholangiopancreatography (MRCP) showed the same thing, but with a questionable impacted gallstone in the neck of the gallbladder. The patient was taken to surgery for a laparoscopic procedure initially. My question is this: Why was an MRCP done when the obvious diagnosis was made and surgery was clearly indicated? Isn’t this a waste of $3,500
to $5,500 when the patient clearly needs surgery anyway? This expensive MRCP did not really change the operative approach, and an operative cholangiogram was done anyway. In today’s atmosphere of trying to cut the cost of medicine, this kind of unnecessary expense in patient care just isn’t warranted, and I would consider it lazy medicine. What is happening to the use of common sense in surgical decision making in the year 2012? The idea of defensive medicine would not even be an issue in a case like this.
Elias Chousleb, MD,
Reply
Expert From the April 2012 Lounge I thank Dr. Pardieck for bringing up the very important point of unnecessary testing, in this case, the unnecessary MRCP. Within the limitations of The Surgeon’s Loungee column, since the
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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
focus was mainly on avoiding injury and treatment of the problem, we did not address this issue. However, as Dr. Pardieck stated, unfortunately in medicine today, where technology is widely available in most of the developed world, physicians and other health care providers have a tendency to overuse and abuse diagnostic testing. As a surgical consultant, it is not uncommon for me to be called to see a patient who has already undergone a series of expensive testing. Like Dr. Pardieck, I also feel that we should base our efforts on educating our future physicians in
returning to that old practice of examining patients before ordering every test in the book. Imaging should be used as a confirmation of a presumptive diagnosis rather than the primary diagnostic modality, and reserved for those cases in which the result will affect the therapeutic strategy.
Correspondence From Roger E. Alberty, MD, FACS, Portland Dr. Alberty’s correspondence touched on several points, one of which related to the Expert Express (“Single Incision
Laparoscopic Surgery [SILS], Yes or No?”) from the April 2012 issue of General Surgery News. Dr. Alberty noted that in his reply, one of our experts was advertising his product. Dr. Alberty found this offensive and suggested that in the future, experts in The Surgeons’ Loungee consider avoiding advertising specific products. Dr. Alberty also commented that many guest experts in The Surgeons’ Loungee do not clearly express what they would do in the cases presented.
OD
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Fredeerick Greene, MD: No mesh h
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In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Residual Paralysis: The Problem That Won’t Go Away B Y A DAM M ARCUS
S
ixty years ago, Henry Knowles Beecher, MD, and Donald Todd, MD, published a provocative study in the Annals of Surgery. The study showed that patients given neuromuscular blocking agents were six times as likely to die in recovery as those who did not receive the drugs. Most of that excess mortality resulted from respiratory events.
Six decades later, shockingly little has changed. As many as 100,000 patients annually in the United States suffer respiratory complications and other adverse events after surgery because they experience residual paralysis from neuromuscular blocking agents, experts warn. The lack of clinical standards for monitoring post-surgery weakness means the situation is unlikely to improve anytime soon, said Sorin Brull, MD, professor of
anesthesiology at Mayo Clinic, in Jacksonville, Fla. “I feel very strongly that the American Society of Anesthesiologists should come up with some standards for perioperative monitoring,” Dr. Brull said. Although there are no firm data on the scope of the problem, Dr. Brull backed out an estimate of the potential scope of residual paralysis at the 2012 annual meeting of the International Anesthesia Research Society, in Boston.
Of the roughly 40 million surgeries performed in the United States each year, about 60%, or 24 million, involve general anesthesia. If residual paralysis occurs in as much as 40% of patients who receive general anesthesia—admittedly near the top end of the range—he said, that’s 10 million patients. Critical respiratory events will affect 0.8% of those patients, and another 0.1% will require emergent reintubation in the postanesthesia care unit (PACU). The total: approximately 100,000 cases per year of potential harm “directly related” to residual paralysis. “I know it doesn’t happen here,” Dr. Brull said facetiously, referring to the anesthesiologists in the audience. “But it does happen.” Part of the problem is that the clinical tests for residual paralysis are not especially accurate. That goes for subjective train-offour monitoring, feeling for the contraction of the affected muscles, or evaluating patients by their clinical correlates—how firmly they can bite a tongue depressor, squeeze a hand or hold up their heads. “All of the clinical tests, all of them, have a very low predictive value,” Dr. Brull said. “Even though 100% of clinicians use them, 99.9% of us are wrong half the time.” That might be an overstatement, but the condition does seem to have a way of eluding anesthesiologists, said Glenn Murphy, MD, director of cardiac anesthesia and clinical research at NorthShore University HealthSystem, in Chicago. Dr. Murphy said that the vast majority of clinicians report never having seen a case of the complication, which seems unlikely, he said, given that “I see it a couple of times a month. If quantitative neuromuscular monitors are used in the PACU, most clinicians would discover that adverse respiratory events related to residual neuromuscular block are not rare events.”
Unambiguous Safety Issue
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Nor is it a trivial complication safely ignored. “There’s clearly a patient safety issue involved here,” Dr. Murphy said. Adverse events can range from mild airway obstruction to life-threatening hypoxemic episodes. Residual paralysis also affects the quality of recovery, said Dr. Murphy, who has studied the issue. “When we leave patients with residual block, they experience a variety of unpleasant symptoms of muscle weakness during the PACU admission.” In one such trial, Dr. Murphy’s group randomized patients to quantitative neuromuscular monitoring (TOF-Watch SX, Bluestar Enterprises) or no monitoring in the operating room. “When we evaluated
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
them for symptoms and signs of muscle weakness, they clearly felt a lot worse” when experiencing residual block, he said. The available reversal agents are at least partly to blame, he said. Neostigmine in particular does not work very well. “In the best of circumstances, it takes an average of 10 to 15 minutes to achieve complete neuromuscular recovery. The problem is we are pulling the endotracheal tube out without demonstrating that full recovery of muscle activity has occurred.” As it happens, the muscles that maintain airway tone are exquisitely sensitive to blocking agents. When weak, they can obstruct and collapse. Small degrees of residual block appear to be more threatening for patients who are predisposed to airway difficulties.
High-Risk Populations “The majority of patients with a little bit of residual block in the PACU will feel weak, but won’t develop life-threatening problems,” he said. “But if a patient with minimal pulmonary or cardiac reserve is left with incomplete neuromuscular recovery, significant adverse respiratory events may occur following tracheal extubation.” As same-day operations become more common and the use of short-acting anesthetics like propofol and desflurane broadens, residual paralysis is likely to become a common postoperative occurrence, Dr. Murphy added. Aaron Kopman, MD, a retired professor of anesthesiology at New York Medical College, in Valhalla, has been working with Dr. Brull on a journal article about residual paralysis. “While there’s a general consensus as to what should be done in terms of monitoring, there is a huge disconnect between what neuromuscular aficionados suggest and what is done in the real world,” Dr. Kopman said. “Probably 50% of anesthesiologists don’t use proper monitoring even though it’s available.” Why the practice gap? Although Dr. Kopman said the answer is complicated, part of the problem is that most nerve stimulators do not provide quantitative data. “They don’t give you a number you can deal with. Without that, I think people tend not to use the devices.” The lack of official guidelines doesn’t help, he added, as does what he said was the fate of articles and editorials on the subject: “They fall into a black hole.” To be fair, Dr. Kopman said, the problem is not isolated to the United States. In 2007, the Association of Anaesthetists of Great Britain and Ireland recommended that nerve stimulators “must be available whenever a muscle relaxant is used during induction and maintenance of anesthesia and must also be immediately available in recovery.” But two years later, Richard Birks,
MD, chairman of the group that created the guidelines, published a letter to the editor of Anaesthesia, the association’s official journal, which hedged that position somewhat. Dr. Birks stated that “neuromuscular monitors should be available rather than attached routinely”—a position with which Dr. Kopman said he “could not disagree more,” Dr. Kopman said. “Our professional societies are not providing leadership.” Jeffrey L. Apfelbaum, MD, chair of the ASA’s Committee on Standards and Practice Parameters (CSPP), said the panel will not be reviewing issues related
to residual paralysis this year. “We recognize that it’s an area of interest and it is in queue for consideration.” Dr. Apfelbaum, from the University of Chicago, noted that CSPP receives many such requests on important areas of interest from ASA members annually and prioritizes them for consideration, review and possible publication. Publications in 2012 include statements on central venous access, preanesthetic evaluation, postoperative vision loss and acute pain management in the perioperative setting. Several other practice parameters are in various stages of production. Each of
these documents typically involves hundreds of hours of work by physician volunteers and costs the ASA approximately $250,000 to produce—an outlay that covers expenses including travel, production costs and the consultant fees of two independent experts tasked with validating the analyses of the clinician volunteers. As a result, Dr. Apfelbaum said, the CSPP can do only so much in a given year. Dr. Brull “is right,” Dr. Apfelbaum said. “It’s certainly a topic of interest, but when we have prioritized it, it hasn’t yet risen to the top of the list.”
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In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Surgical Oncology Fellowship Grads Turn to Academic Centers Snapshot of New Surgical Workforce; Surgical Oncology Training Changing With New ACGME Requirements B Y C HRISTINA F RANGOU ORLANDO, FLA.—Three-fourths of recent graduates of surgical oncology fellowships go on to work in academic centers whereas 25% enter private practice, according to a new study presented at the 65th Annual Cancer Symposium of the
Society of Surgical Oncology (abstract 109). “The majority of fellows continue to practice in academic teaching institutions, where they train surgical residents to deliver cancer care,” said lead author Rebecca Wiatrek, MD, surgical oncology fellow at City of Hope Hospital, in Duarte, Calif.
The study provides a snapshot of the new surgical workforce in cancer care. The report comes at an important time for oncologic surgical care: The demand for oncologic surgeons is growing and surgical oncology training is going through a transformation with the implementation of new Accreditation Council for Graduate Medical Education (ACGME) requirements and work-hour restrictions.
‘Und ‘U nder erst rsttan anding and ng cur urreent nt pra ract ccttices ices ic es ooff rec ecen ent ggrraadduaate tes ca tes can an he help lp to ccrreeaattee an eefffi cre fffiici cie ieennt eedduc ucat atio tio ionnaal iona desiign de gn.’ —R Reb becca ca Wia iatr trrek trek ek, k, M MD D
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In 2011, the American Board of Surgery launched new board certification in complex surgical oncology. The board introduced the certificate to improve the care of cancer patients with complex cases requiring intensive, multidisciplinary treatment. The board contends that patients would benefit from the training programs accredited by the ACGME, which ensures consistent standards for all programs. Historically, graduates from SSO fellowships have moved into academic practices at high rates. A 1999 survey of graduates from the University of Texas MD Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center showed that 74% were in fulltime academic positions, 6% were in academic part-time positions and 20% were in private practice positions ((Ann Surg Oncol 1999;6:424-432). In the new study, investigators looked at practice patterns among 253 surgeons who matched to 18 Society of Surgical Oncology (SSO) training programs between 2003 and 2008. Of these, 43 trainees were excluded from the survey because they had not completed their training (n=10), were working outside the United States (n=22) or were with the military (n=11). Among the 120 survey respondents, 61% were employed at university hospital centers or National Cancer Institute (NCI) Cancer Centers. Another 8% worked at university-affiliated hospitals with surgical residents and 6% worked at community hospitals with surgical residency programs. Women matched to surgical oncology fellowships at a lower rate than expected based on the number of women in medical school, the results showed. Over the study period, women accounted for 34% see FELLOWSHIP PAGE 33
© Atrium Medical Corporation 2012. All rights reserved. Atrium and C-QUR CentriFX are trademarks of Atrium Medical Corporation, a MAQUET GETINGE GROUP company.
Opinion
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
“Damned if you do…” B Y S KEPTICAL S CALPEL
H
ere’s a little story from the early days of my first job as a chairman of surgery. Shortly after I assumed the role of surgical chairman in a community teaching hospital at the ripe old age of 40, I decided to visit a mentor of mine whom I had known since I was a medical student. He had been serving in a similar role at a larger hospital than mine, and I thought he might be able to share some wisdom about how to be a good chairman. He was dispensing sound, practical advice for about an hour. Then he said something that struck me: Sometimes the unexpected happens and there’s no simple solution. He told me that among the challenges he was facing were two lawsuits. One was from the family of a patient who had died after a carotid endarterectomy that had been performed by a surgeon in his department. The plaintiffs were suing the hospital and my mentor, the surgical chairman, for allowing what they alleged was an incompetent surgeon to do complex vascular surgery. The other lawsuit was by a surgeon in his department who had requested privileges to perform carotid surgery, which my mentor had denied because, in his opinion, the surgeon was not adequately trained in carotid surgery. I never heard the outcome of either case, but they certainly seemed like a no-win situation. Although my conversation with the chairman occurred some 25 years ago, many of the problems we discussed persist today. For example, patient advocates are concerned that pain is not adequately addressed, yet there is an epidemic of abuse of narcotic prescription drugs sweeping the country. We also are being criticized for runaway health care spending and are being encouraged to reduce things like unnecessary testing; however, a recent jury verdict for $6.4 million in Philadelphia went against two physicians for failing to order certain tests on a man who had a fatal heart attack three months after an emergency department visit for pneumonia (see “Phila. jury renders $6.4 million plaintiffs' verdict in medical malpractice, wrongful death case” at http://pennrecord.com). Some say too many CT scans are being ordered for the work-up of appendicitis with worry that radiation will cause future increased cancer rates. However, in my experience, patients prefer accuracy in diagnosis over a theoretical increased
risk for cancer 30 years from now. Not long ago, I was called by an emergency physician who said he had a 17-year-old boy with a textbook case of acute appendicitis. He felt a CT scan was unnecessary. I examined that patient and agreed. I explained to the boy’s mother that I was convinced he had appendicitis and needed surgery. She said, “What about a CT scan?” After a lengthy discussion,
I convinced her that the CT scan was not needed. As I made the incision, I said to the OR team, “I sure hope this kid has appendicitis.” I can think of many more such situations. But how should we resolve them? The mantra for modern medicine seems to be, “Damned if you do and damned if you don’t.”
Skeptical Scalpel is a practicing surgeon and was a surgical department chairman and residency program director for many years. He is board-certified in general surgery and a surgical subspecialty and has recertified in both several times. For almost two years, he has been blogging at SkepticalScalpel.blogspot.com and tweeting as @SkepticScalpel. His blog has had more than 195,000 page views, and he has in excess of 2,800 followers on Twitter.
Less pain. Less opioids. OFIRMEV® provides significant pain relief*1 • OFIRMEV 1 g (Q6h) + patient-controlled analgesia (PCA) morphine demonstrated significant pain relief vs placebo + PCA morphine (P<0.05 over 6 h)1 • OFIRMEV 1 g (Q6h) + PCA morphine showed greater reduction in pain intensity over 24 h (SPID24)† compared to placebo + PCA morphine (P<0.001)2
OFIRMEV reduces opioid consumption*1 • OFIRMEV 1 g (Q6h) + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine (–46% over 6 h, P<0.01; –33% over 24 h, P<0.01)1 • The clinical benefit of reduced opioid consumption was not demonstrated
Schedule OFIRMEV Q6h for the first 24 h • Continue OFIRMEV or transition to PO analgesia based on patient assessment
Indication OFIRMEV is indicated d d ffor the h management off mild ld to moderate d pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever. Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.
OFIRMEV should be administered only as a 15-minute intravenous infusion. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. OFIRMEV is approved for use in patients ≥2 years of age. The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain. To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com. Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.
*Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. †SPID24=sum of pain intensity differences, based on VAS score, from baseline, at 0 to 24 h.
References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. y 2005;102:822-831. 2. Data on file. Cadence Pharmaceuticals, Inc.
©2012 Cadence Pharmaceuticals, Inc. All rights reserved.
OFIRMEV and the OFIRMEV dot design are trademarks of Cadence Pharmaceuticals, Inc.
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31
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In the News TACKS
jcontinued from page 1 of the double crown, the surgeons placed a tack at every third or every fourth mark and filled in the gaps with fibrin glue. Lab studies have shown that fibrin glue has a chemotactic effect, increasing the collagen, spurring new vessel growth and consequently causing a biological rather than mechanical fixation. In a series of 38 patients, Dr. MoralesConde and her team showed they could reduce the number of tacks by 66% by
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
‘I think with this study, we have shown the feasibility of this technique, which decreases mechanical fixation and should reduce acute and postoperative chronic pain without increasing the recurrence rate.’ —Salvador Morales-Conde, MD using this technique. All patients included in the study had primary or secondary ventral hernias, located at the midline, far from bones and sizes ranging between 3×3 and 17×12 cm. There were no intraoperative complications; postoperative days in the hospital
averaged 1.62 days with a range of one to seven. Two patients (5.7%) were readmitted due to paralytic ileus. None of the patients reported chronic pain at a median follow-up of 24 months. Without a control group, however, the team could not demonstrate any changes in
pain compared with standard fixation techniques. To date, none of the patients has developed a recurrence after a median follow-up of 24 months. One patient was diagnosed with a “tack hernia,” a condition that’s been described in the literature as a fascial defect related to the tack site ((JSLS S 2003;7:383-387). The Spanish research team is continuing to add to its series. The team currently is using plastic permanent tacks, rather than titanium spiral tacks, in the same technique. The researchers hypothesize that plastic permanent tacks will create less adhesions. Surgeons who heard the study presented say the technique is promising but longer follow-up with more patients is needed. “We have a long way to go, but this is certainly something to watch,” said Karl LeBlanc, MD, MBA, past president of the American Hernia Society and director and program chair of Fellowship Program, Minimally Invasive Surgery Institute, Baton Rouge, La. One surgeon present questioned the “tack hernia,” saying he felt that it was a form of recurrence. However, both Drs. Morales-Conde and LeBlanc, who first reported on tack hernias, said that it represents a new hernia. The surgical team is following a watch and wait approach for the tack hernia because it is small and asymptomatic, said Dr. Morales-Conde. Several groups in Spain and Italy have adopted the new technique but there are no reports of surgeons using it in the United States. Dr. Morales-Conde reported no relevant disclosures. The glue used in the study is Tissucol (Tisseel in the United States), which is manufactured by Baxter.
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In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
Analysis revealed that the response to the postoperative complications led jcontinued from page 1 to the difference in mortality rates. Of new study presented at the 132nd annu- DNR patients who developed a major al meeting of the American Surgical complication, 57% died within 30 days of Association (ASA). surgery, which was 18 percentage points Investigators call this phenomenon a higher than the rate among patients â&#x20AC;&#x153;failure to pursue rescue,â&#x20AC;? and say sur- without a DNR. DNR patients were also geons, caregivers and policymakers need significantly less likely to undergo reopto be aware of the trend. eration following the index operation; â&#x20AC;&#x153;Failure to pursue rescue is a more only 8% had a second operation, comaccurate description of what happens pared with 12% in the non-DNR group. here,â&#x20AC;? said lead author John E. Scarbor- The investigators believed that the lower ough, MD, assistant professor of trauma reoperation rate among DNR patients and surgical critical care, Duke Univer- was due to a refusal to consent to followsity Medical Cenup interventions. ter, in Durham, N.C. The findings could â&#x20AC;&#x2DC;Itâ&#x20AC;&#x2122;s not that patients die â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s not that patients help surgeons and die after massive after massive attempts to policymakers who attempts to premanage the care of prevent their deaths; itâ&#x20AC;&#x2122;s vent their deaths; itâ&#x20AC;&#x2122;s geriatric patients. that these patients or that these patients or their For general and acute their families refuse families refuse to accept care surgeons, the to accept aggressive results provide objecmanagement of their aggressive management of tive data they can use complications.â&#x20AC;? when advising elderly their complications.â&#x20AC;&#x2122; The study is based DNR patients about on an analysis of â&#x20AC;&#x201D;John E. Scarborough, MD the risks of emergent data collected by surgery, the investigathe American Coltors said. lege of Surgeons National Surgical QualSurgeonsâ&#x20AC;&#x2122; conversations with comproity Improvement Program between 2005 mised elderly patients and their families and 2010. In that period, 25,518 patients are difficult and surgeons need to learn older than 65 years underwent an emer- how to better counsel these patients, said gency operation for one of 10 common Ronnie A. Rosenthal, MS, MD, profesgeneral surgical conditions. Of these sor of surgery at Yale University School patients, 4.2% (n=1,061) signed preoper- of Medicine, in New Haven, Conn. ative â&#x20AC;&#x153;do not resuscitateâ&#x20AC;? (DNR) orders Even after those discussions have before their index operation. occurred, an ethical dilemma can arise Overall, 37.2% of elderly DNR when a patient has complications after patients died in the 30 days following sur- surgery. â&#x20AC;&#x153;The ethical dilemma is that the gery, the study showed, and 42% experi- surgeon may well feel that rescue from enced major complications. Patients who the complication is possibleâ&#x20AC;&#x201D;which the signed DNR orders were older, had poor- study supports since mortality following er functional status, higher ASA physical a complication in the matched non-DNR status scores and higher rates of cogni- patients is lower while the complication tive dysfunction, malignancy, conges- rate is the sameâ&#x20AC;&#x201D;but patient autonomy tive heart failure and other comorbidities demands respect for the patientâ&#x20AC;&#x2122;s right to than non-DNR elderly surgical patients. stop further treatment,â&#x20AC;? Dr. Rosenthal The patients who signed DNR orders wrote in an e-mail interview with Genwere also more likely to receive preoper- eral Surgery News. ative transfusions, undergo longer operaThe results send a strong message tions and have procedures associated with about misclassifying these cases as â&#x20AC;&#x153;failhigher total work relative value units, ure to rescue.â&#x20AC;? Failure to rescue typically used as a marker for complexity. is used to describe a patient death folInvestigators performed propensi- lowing postoperative complications, and ty score matching to compare DNR and is used as an important patient safety non-DNR patients with similar patient- indicator; however, the researchers argue and operation-related variables. The that failure to rescue and failure to pur30-day mortality was significantly high- suee rescue should not be lumped as one. er among patients who signed a DNR, at The investigators added that they were 36.9%, than among non-DNR patients pleased to find no difference in pre- and of whom 22.3% died within the same perioperative treatment of patients relatperiod (odds ratio, 2.07; 95% confidence ed to their DNR status. â&#x20AC;&#x153;Our findings interval, 1.69-2.55). Despite the differ- do not support the existence of an overt ence in mortality, the incidence of major bias among physicians against aggressive postoperative complications was simi- preoperative or intraoperative managelar between the two groups, at 42.1% for ment of elderly DNR patients,â&#x20AC;? said Dr. DNR patients and 40.2% for non-DNR Scarborough. patients.
RESCUE
FELLOWSHIP jContinued from page 30 of all surgical oncology graduates, but women represented 47% of medical school enrollees. The study also showed that most graduates of surgical oncology fellowships maintain a broad-based surgical oncology practice once they graduate. Sixty percent of surveyed fellows work in general surgical oncology practice. The trend toward general oncology is particularly pronounced among surgeons in private practice; 87% of graduates who went into private practice work in a broad-based practice. In contrast, specialized surgeons tend to stay in academic hospitals. For example, nearly all of the 40 surgeons who focus on hepatopancreatobiliary surgery work in academia; only two work in private practice. Although the majority of surgical oncology graduates work in academia, most surgical cancer care is performed in non-academic settings. As such, one of the roles of SSO graduates has been teaching general surgery residents who then go on to provide cancer care to the community, said Dr. Wiatrek.
The results could help surgical educators redesign training programs, especially considering surgical oncology programs are now being revamped to meet new ACGME standards, Dr. Wiatrek noted. â&#x20AC;&#x153;Understanding current practices of recent graduates can help to create an efficient educational design,â&#x20AC;? said Dr. Wiatrek. â&#x20AC;&#x153;Programs will likely be evaluating and possibly changing how they are currently structured, especially in light of new workhour restrictions.â&#x20AC;? Dr. Wiatrek added, â&#x20AC;&#x153;I think this study can help programs prepare for the eventual practice types of graduates and ensure that critical elements are not sacrificed in the restricted work-hours.â&#x20AC;? Monica Morrow, MD, professor of surgery at Weill Medical College of Cornell University, in New York City, and president of the Society of Surgical Oncology, said she was not surprised by the results of the study. â&#x20AC;&#x153;The study emphasizes that broad-based surgical oncology training, such as that provided in SSO-approved surgical oncology fellowship programs, is the route to a faculty appointment at many academic medical centers.â&#x20AC;?
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MD, AND L. G REENE , B Y F REDERICK , MD L AUREN K OSINSKI the g to hear t was intriguinthat the Disg recent news y was beginnin ney Compan promote good to only an initiative choices by advernutritional food product accepting healthful options. inipromoted company â&#x20AC;&#x2122;s tisers that the applaud We should obesity epidemcombat the audience tiative to ing its young with ic by encourag magic of Disney the to associate healthful foods.other recent A slew of to have tried initiatives better eating encourage young peohabits among years ago, ple. Sixteen the celebrity Alice Waters, of Chez Panisse Restaung nouvelle chef founder with introduci diners, estabrant credited American rd Project cuisine to Edible Schoolya in Berkelished an Lunch Initiative were built and School These programs emphaley, Calif. cuisine concept and on the nouvellefresh, locally grown prepared in sizing eating available foods enhanced the seasonally ways that ts. uncomplicated of the base ingredien natural ďŹ&#x201A;avors FOOD FOR THOUTH page 34
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Opinion FOOD
FOR
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
THOUGHT
jcontinued from page 1
base ingredients. The Edible Schoolyard engages middle school children in garardening and recycling projects that not only help the students appreciate coonnections between food and culture, but also allow them to participate in the haarvest, which ultimately contributes to the lunches 10,000 children receive each day. In a similar venture, celebrity chef Jamiie Oliver aired a reality television series in n 2010 intended to help combat obesitty by educating and inspiring young peoople, who previously could not identiffy common fruits and vegetables, to grow w and prepare fresh food. His work con ntinues through the Jamie Oliver Foun ndation. And we can’t forget Michelle Obama’s campaign to improve schoool lunches, which in the past six montths prompted the U.S. Department of Agrigriculture to make some major revisions to nutritional standards for school lunches. In the same week as Disney’s announcement, New York City Mayor Michael Bloomberg was advocating banning the sale of large sweetened drinks— an intriguing approach to reducing the consumption of sugar and addressing problems of diabetes and obesity. It may,
In most of the hospitals in the United States, the food offered to patients, visitors, support staff, nurses and physicians has no place in institutions whose sole purpose is promoting good health.
however, be very difficult to have appropriate oversight and sanctions to assure that this soft drink ban or the Disney initiative have the anticipated outcome. All around us, there is growing commitment to improving eating habits to prevent obesity, heart disease and diabetes in order to live more sustainably and have a better quality of life. But even
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MN119
with these changes, Congress deemed pizza a vegettable in 2011 to keep it as an op ption on school cafeteria men nus, and special interest ggroups that represent virtually every pizza ingredient marshaled their forces to resist alterations in pizza composition. No wonder children are confused! So where do we as phyS sicians sttand? Some of us are the worst offen nders. Coke and Mountain Dew are coonsidered the “breakfast of champions” aamong surgical residents and staff staff. The last l time most of us had a real breakfast on a weekday was probably when we were home sick: a long time ago. We rarely stop for 15 minutes to eat during the day. Needing to eat (or drink) has been seen as a sign of weakness among surgeons. In fact, one department chairman was famous for never being seen eating. At best, coffee and a high-glycemic-index donut comprise the morning offerings at most of our conferences. Our hard-working cafeteria staff endeavor to make healthy meals, but we still have ice cream bars instead of juice bars and an abundance of fried foods on the breakfast, lunch and dinner lines. If you’re hungry or thirsty after a late case in the operating room, the vending machines in the lounge and the rest of the hospital usually are fully stocked with candy, chips and soda. In most of the hospitals in the United States, the food offered to patients, visitors, support staff, nurses and physicians has no place in institutions whose sole purpose is promoting good health. Once the diner gets past the salad bar (which also often has an abundance of canned foods or vegetables sliced, diced and packaged in ways that reduce their value), most of what can be found is the antithesis of nutritional well-being. Perhaps the time has come for us to reconsider our eating habits and relearn how preparing, enjoying and sharing food can help us be healthier and happier. Health care providers, however, may face many obstacles on the road to healthier living. Just as eliminating tobacco products within hospitals encountered great resistance from within our own ranks, instituting better food practices may cause similar opposition. There are many ways we can positively affect the nutritional landscape in our own hospitals. While making rounds, we often have the occasion to cast a glance at
our patients’ trays. We should take opportunities to look at the foods our patients are eating as they recover and talk to them about good nutrition. We can each be positive forces for change if we see that our hospital dining facilities are guilty of serving fatty and starchy foods rather than fresh or organic produce, grains and caffeine-free and sugar-free beverages. We also can make sure that the impulsebuy choices at the cafeteria are healthier. We can ask for different kinds of foods at our conferences and try to encourage work breaks throughout the day to eat. We also should be sure our residents and students are eating during the day, perhaps by providing thermoses or insulated lunch bags as thank yous for good work instead of coffee coupons. The difficulties legislating lifestyle changes are obvious. The thirsty New Yorker wanting a Big Gulp can simply substitute two regular size sodas for the prohibited ginormous one. It is less obvious to discern whether savvy advertising campaigns reflect corporate values. Will Disney practice what it preaches? Efforts to capitalize on consumer approval by restricting advertising contracts to nutritionally reputable products may have no bearing on what is actually serviced at Disney Enterprises. It is reported that 30 tons of fruits and vegetables grown at Epcot Center are served in Disney World restaurants, but apparently each year visitors consume nearly six Cokes for every bottle of water, and 10 million hamburgers, six million hot dogs and nine million pounds of french fries are served. Likewise, we must consider whether we physicians will embrace the behaviors we advocate. We have a real opportunity in our health care centers to take a leadership role to create an environment that promotes good nutritional concepts for patients, visitors and health care personnel. Institutions should be highlighted for their best practices and serve as examples of good nutritional approaches to health. Reducing obesity and preventing gastrointestinal cancer and heart disease begin in our hospitals and health care facilities. All of us, and especially those who serve in medical staff leadership positions, should make it known to our nonmedical administrative colleagues that foods with unacceptable nutritional value have no place in an environment that is promoting good health. In meeting this challenge on behalf of the patients we serve, we also have the chance to take care of ourselves, perhaps even to redefine the admirable surgeon as the one who works hard but lives well too. —Dr. Kosinskii is an assistant professor — of surgery, Medical College of Wisconsin, Milwaukee, and Dr. Greene is a general surgeon and surgical oncologist from Charlotte, N.C.
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Principles and Practice of Surgery: With Student Consult Online Access, Sixth Edition
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Over the past decade, the percentage of elective surgical procedures performed on a day case basis has increased from 55% to over 70%. This concise handbook provides the practicing day surgery professional with a modern overview of current practice to act as both a reference a d a practical and p act ca guide gu de to everyday e e yday challenges. c a e ges
This is a comprehensive textbook for both the surgical student and trainee, guiding the reader through key core surgical topics which are encountered throughout an integrated medical curriculum as well as in subsequent clinical practice. This text covers both the medical and surr g gical implications p of diseases encountered in surgical g wards. GSN0712
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In the News GASTROPARESIS GES jcontinued from page 1
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2012
AND
‘After our study, we think we should tell patients right away that the laparoscopic subtotal gastrectomy also can be seen as a primary therapy.’
Joerg Zehetner, MD, assistant professor of surgery in the Department of Surgery, Keck School of Medicine, University of California, Los Angeles, who presented the research at this year’s annual meet—Joerg Zehetner, MD ing of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES; S101). “But now, after our study, we think we should tell patients right away that the laparoscopic subtotal gastrectomy also can be seen as a primary therapy because it has a significantly higher rate of symptom improvement, acceptable morbidity and comparable mortality to the GES.” The researchers, led by John C. Lipham, MD, evaluated outcomes in 103 patients who received treatment at their center for medically refractory gastroparesis between January 2003 and January 2012; 72 patients received GES by either laparoscopy (n=20) or mini-incision (n=52), and 31 patients received a laparoscopic subtotal (n=27), total (n=1) or completion gastrectomy (n=3). Thirty-day morbidity was significantly Keith Professor and chair of the Depart“We know now that GES works, and greater in the gastrectomy groups than in ment of General Surgery, Rush Universi- that it works better in some subgroups,” those who received GES (23% vs. 8%) but ty, Chicago, found it interesting that there said N.V. Jayanthi, MD who presentthis difference leveled out over time; in- was no statistically significant difference ed the research at SAGES (S102). “But hospital mortality was about 3% for both in morbidity and mortality between the we don’t know who fails to improve with groups. two groups. GES. So that brings us to tGES.” About two-thirds (63%) of the patients “One might intuitively think GES a in the GES group achieved symptom safer approach. Perhaps the number of Temporary GES: Another Option improvement as assessed by the Gas- patients in each group was too small to The idea of using tGES to predict who troparesis Cardinal Symptom Index, detect a difference, or perhaps this sim- will benefit from permanent GES is not whereas 87% of those in the gastrectomy ply reflects the fact that this is a seriously new. “Dr. Thomas Abell proposed this group reported significant improvement compromised patient population to start several years ago,” said Abeezar I. Sarein nausea, vomiting, epigastric pain and with,” he said. la, MD, FRCS, Department of Upper other symptoms that plague gastropare“It would be important to know the Gastrointestinal, Metabolic and Bariatric sis patients. In the GES group, 19 (26%) factors ahead of time that might pre- Surgery, St. James’s University Hospital, had to have the device removed due to dict which patients would be more like- Leeds, United Kingdom. “But the uptake device malfunction, infection or failure to ly to improve following GES, resection on tGES has been quite low.” respond; these patients received laparo- or other procedures that have been used,” Dr. Abell’s initial research showed a scopic subtotal gastrectomies, 97% response rate in patients ‘But lacking other tools, tGES is less and 100% reported symptom selected by tGES (Digestion improvement. 2002;66:204-212). Subsequent invasive and shows that in selected patients, Notably, of the patients research showed a strong corit can improve GES success rate.’ who failed GES, 80% had relation between symptom diabetes-related gastropareimprovement in tGES and —N.V. Jayanthi, MD, FRCS sis. “This was a little unusupermanent GES (Gastrointest al because you would expect Endosc 2005;61:455-461), and those with diabetes gastroparesis to Dr. Deziel continued. “Is success related tGES is used as a treatment for nausea respond better,” than patients with idio- to the etiology of the disease? If we knew and vomiting in patients who do not have pathic or postsurgical gastroparesis, Dr. this, we might be more effective in terms gastroparesis (Digestion 2011;83:1-2). Zehetner said. of our initial therapeutic recommendaDr. Sarela has long been interested in In conclusion, the researchers recom- tions, and could perhaps identify patients GES for gastroparesis, a condition he mended laparoscopic subtotal gastrecto- who would not benefit from any major thinks is far too often under- or misdiagmy as a primary treatment, and to reserve operative intervention other than jejunos- nosed. “The vast majority of patients with GES for patients who don’t want a gas- tomy placement.” gastroparesis are lost among the diagnosis trectomy or a more invasive procedure. Researchers from the United King- of functional dyspepsia,” he said. “I think “The good thing about the stimulator is dom attempted to answer some of these this is due to lack of awareness. But even that we can see it as a breaching treat- questions by seeing if placement of tem- if we do make a diagnosis of gastropament; it does not prevent us from doing a porary GES (tGES) could predict which resis, there are very few definitive treatgastrectomy,” Dr. Zehetner said. patients would benefit from a permanent ments for that condition.” Daniel J. Deziel, MD, Helen Shedd GES. The most problematic patients are
those who do not improve with dietary changes and prokinetics, and whose condition is so severe that they cannot tolerate oral intake and require jejunostomy tubes. “That is a miserable existence for these patients,” Dr. Sarela said. “For patients with gastroparesis of this sort, the treatment options are very limited.” As far as the mechanism by which GES works in gastroparesis, “we do not know; it is not as simplistic as it improves gastric emptying, and there have been conflicting studies,” Dr. Sarela said. “We had positive experiences with GES, but one dilemma is that not everyone benefits. It is a fairly straightforward procedure, but still invasive and carries some risk for side effects and complications. It also is very expensive so it’s important to select the patients most likely to have a good response.” Dr. Sarela’s team set out to see if they could establish a role for tGES in patient selection. Of 71 patients with medically refractory gastroparesis referred to their center, 51 received tGES. “We endoscopically placed an electrode into the stomach lining. The electrode runs through the patient’s nose and connects to the stimulator on the outside. That is kept in place for about two weeks, during which time the patient maintains a symptom diary and we assess how well they do,” Dr. Sarela said. Improvement was seen in 39 (74%) patients, and 31 received a permanent GES. At 10 months follow-up, 22 (71%) showed significant sustained improvement compared with a 50% improvement associated with GES in the longest see GASTROPARESIS AND GES page 39
GSN Bulletin Board
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JULY 2012
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GASTROPARESIS GES
AND
jContinued from page 36 series to date (Clinical Gastroenterol Hepatoll 2011;9:314-319). It is not yet clear whether transmucosal stimulation is equivalent to GES. Also, not all patients tolerate the stimulation, and leads can dislodge inside the stomach without patients or physicians realizing it. “But lacking other tools, tGES is less invasive and shows that in selected patients, it can improve GES success rate,” Dr. Javanthi said. Interpreting the presentation, Dr. Deziel noted that although the results were promising, the follow-up was fairly short. “We have to keep in mind how durable and significant is the clinical response,” he said.
‘The vast majority of patients with gastroparesis are lost among the diagnosis of functional dyspepsia.’ —Abeezar I. Sarela, MD, FRCS
Also, the improvement was based on patient self-reporting. “We didn’t really have any objective physiologic measures of improvement—it would be interesting to know if they had any objective data to quantify the effect of the pacing on gastric emptying, and whether it is gastric emptying of solids or liquids and how that correlated with symptom improvement,” Dr. Deziel said. Dr. Deziel added, “One question I have is why some patients responded to tGES and not GES.” The answer to that may have to do with the differences between tGES and permanent GES in terms of how the electrodes are placed, and perhaps in other difference between the two modalities that are not well understood at this time. Regardless, “there seems to be a good increase in success that we see with tGES,” Dr. Sarela said. “Once we are to the stage of treating someone with GES, we should consider a tGES as a selection parameter.” Most important, however, is management of patient expectations. “When they come to our service, they are very desperate and will try anything you want,” Dr. Javanthi said. “This needs to be carefully managed because if it fails, they have no other option than a gastric resection.” Drs. Jayanthi, Sarela and Zehetner reported no disclosures. Dr. Lipham is a consultant for Medtronic.
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REPORT Benefits of GORE速 DUALMESH速 Biomaterial in Hernia Repair: A Case-based Presentation
Introduction from the Faculty Chair Karl LeBlanc, MD Baton Rouge, Louisiana Considered one of the most common types of surgery, hernia repair remains an ongoing challenge for surgeons because
Chair Karl LeBlanc, MD Associate Medical Director Surgeons Group of Baton Rouge/Our Lady of the Lake Physician Group Director and Program Chair of the Fellowship Program Minimally Invasive Institute Adjunct Professor Pennington Biomedical Research Center Baton Rouge, Louisiana Clinical Professor of Surgery Louisiana State University New Orleans, Louisiana
of the risk for recurrence and other complications.1 As a long-standing material used for hernia repair, expanded polytetrafluorethylene (ePTFE) has made strides to maximize the outcomes and address the risks. The use of ePTFE has evolved significantly since its introduction in 1983.2 With early iterations, such as the GORE-TEX速 Soft
Faculty
Carl R. Doerhoff, MD
Srdjan Rakic, MD
Alfredo M. Carbonell, DO
General Surgeon SurgiCare of Missouri Jefferson City, Missouri
Staff Surgeon Department of Surgery Twenteborg Hospital Almelo, The Netherlands
Chief of Minimal Access and Bariatric Surgery Co-Director, The Hernia Center Associate Professor of Clinical Surgery Greenville Hospital System University Medical Center University of South Carolina School of Medicine Greenville, South Carolina
Birgitta Hansson, MD Department of Surgery Canisius-Wilhelmina Hospital Nijmegen, The Netherlands
Antonio Iuppa, MD Chief, Department of Surgery Istituto Oncologico del Mediteraneo Viagrande, Italy
Supported by
Songzhang Ma, MD Professor of General Surgery Beijing Redcross Chaoyang Hospital Capital Medical School Beijing, China
REPORT Tissue Patch (GORE®, W.L. Gore & Associates, Inc.), surgeons could apply a solid, microporous sheet of ePTFE to enhance tissue incorporation while minimizing the risk for recurrence.3 With more recent configurations of ePTFE, particularly GORE® DUALMESH® Biomaterial and GORE® DUALMESH® PLUS Biomaterial (GORE®, W.L. Gore & Associates, Inc.), hernia repair has become more innovative, improving fixation to the abdominal wall and tissue ingrowth, while minimizing adhesion formation and the risk for recurrence.4 Despite these developments, there are several misconceptions regarding its use and longterm outcomes, as well as the costs associated with the ePTFE material. In the past, several publications provided relevant information on the use of ePTFE, but as with many maturing prosthetic materials, surgeons may be overlooking the benefits of this long-standing material when compared with other prosthetics, such as polypropylene and polyester mesh.5 Yet, with studies demonstrating an increased risk for recurrence as well as biomaterial-related complications—adhesion formation and tissue ingrowth—and bowel obstruction when using polypropylene and polyester mesh, understanding how to use ePTFE in hernia repair for different types of patients will increase awareness of the features that continue to make ePTFE the most effective option.6,7 This report will discuss the benefits of using GORE ® DUALMESH® Biomaterial in hernia repair and provide evidence based on recent studies as well as clinical experience.
Understanding the Mechanism Behind ePTFE ePTFE is a fluorocarbon polymer with favorable properties— chemical inertness, a high strength-to-weight ratio, thermal resistance, and biocompatibility—that can be expanded and manipulated to modulate tissue response.8 The fluorine atoms shield the carbon atoms, resulting in a low level of reactivity with other chemicals. Consequently, there cannot be chemical cleavage of the bonds or covalent chemical interactions.9 The strength of the fluorocarbon bonds is an underlying characteristic of ePTFE mesh. The mesh can be placed either by laparoscopy or by an open surgical approach. Unlike sutures, mesh repair minimizes the risk for recurrence and postoperative pain, and is associated with greater patient satisfaction.10 If adhesions occur, the bowel easily can be dissected free from the prosthesis without affecting other tissue or neighboring organs.11,12 Although conventional ePTFE mesh is pliable and can provide effective tissue ingrowth while minimizing inflammation and adhesion formation,5,13 the GORE® DUALMESH® Biomaterial product possesses a smooth surface on the visceral side that mitigates against the development of adhesions to the material. The CORDUROY surface allows for rapid tissue ingrowth. Every surgeon is concerned about the risk for developing a prosthetic infection. The GORE® DUALMESH® PLUS Biomaterial product is the only product on the market that has antimicrobial agents impregnated within it. This has been proven to be an effective agent against methicillin-resistant Staphylococcus aureus (MRSA)14 for up to 14 days postoperatively.
Characteristics of the GORE® DUALMESH® Biomaterial The GORE® DUALMESH ® Biomaterial currently is used in hernia repair—open and laparoscopic—and temporary
2
bridging of fascial defects.15 Unlike its ePTFE predecessors, as well as other meshes—polypropylene- and polyester-based— the GORE® DUALMESH® Biomaterial possesses a 2-sided design with one side to promote ingrowth, while minimizing adhesions on the other.4,16 The GORE® DUALMESH® Biomaterial features a visceral interface side with pores less than 3 microns in size that minimize tissue attachment, and a fascial side—the CORDUROY surface—that includes ePTFE ridges that stimulate tissue fixation on the abdominal wall to create a neoperitoneal surface.4 The GORE® DUALMESH® Biomaterial is soft and supple, allowing it to roll up tightly enough to be inserted into the abdominal cavity with or without the use of a trocar.17,18 In the event that the patient requires radiation therapy subsequent to the hernia repair, ePTFE is able to withstand therapeutic irradiation.19 The GORE® DUALMESH® Biomaterial is the only consistently visible mesh on computed tomographic (CT) scans, which provides a benefit for future evaluations of the abdominal wall to assess the need for any additional surgical interventions.20
Minimizing Adhesion Formation in Hernia Repair The barrier surface of the GORE® DUALMESH® Biomaterial is permanent and proven. One study evaluated the severity of adhesions using GORE® DUALMESH ® Biomaterial at reoperation (N=65), and found that 91% of patients had filmy, avascular adhesions if they had any at all.12 If one has had the opportunity to reoperate on a patient who had undergone mesh implantation, the challenge of minimizing adhesion formation to these materials is not widely publicized. These have proven to be most difficult in many patients regardless of the “tissue-separating” product being used; however, this is not the case with the GORE® DUALMESH® Biomaterial. In cases where patients require reoperation, clinicians are able to see the neoperitoneum on the visceral surface of the material.12 This layer is easily penetrated to expose the underlining ePTFE surface that will appear as pristine as the day of implantation. This layer can be dissected from the mesh so that there is minimal risk for bowel injury.12 This represents a unique quality of the material that is largely unrecognized.
Improving Recurrence Rate With GORE® DUALMESH® Biomaterial Recurrence is considered the most important end point in hernia repair.20 With recurrence rates as high as 58%,21 surgeons have benefited from the use of laparoscopy in ventral and incisional hernia repair. Heniford et al evaluated the safety and efficacy of laparoscopic ventral hernia repair in 850 patients of which 34% were recurrent hernias. GORE® DUALMESH® Biomaterial was used in 97% of patients, and the results showed a recurrence rate of 4.7% in patients at mean follow-up time of 20 months.22 Additionally, patients experienced a shorter hospital length of stay (LOS, 2.3 days) and a low conversion rate to open surgery (3.4%).22 Similarly, Cobb et al conducted a retrospective study (N=270) to evaluate laparoscopic ventral and incisional repairs using GORE® DUALMESH® Biomaterial.17 The average patient was obese and had a large hernia (143 cm2).17 Results showed that the recurrence rate for ventral hernias was 4.7% and that laparoscopic ventral hernia repair was associated with shorter LOS (3 days) and a low rate of conversion to open surgery (2.5%).17
REPORT The strength of the ingrowth of the collagen into the product is considered critical to the prevention of recurrence of herniation following the repair of these hernias with GORE® DUALMESH® Biomaterial. This has been confirmed in the laboratory. One study evaluated the use of GORE® DUALMESH® Biomaterial versus polypropylene mesh in 12 rabbits and assessed adhesions, and found that it had greater attachment strength (P=0.02).4 Additionally, the study showed that 12% of the rabbits in the GORE® DUALMESH® Biomaterial group developed adhesions on the visceral side compared with 88% of rabbits in the polypropylene group.4
Minimizing Infection With GORE® DUALMESH® PLUS Biomaterial In addition to hernia recurrence, one of the ongoing concerns of using prosthetic materials is the infection rate associated with hernia repair. Hospital-acquired infections, including surgical site infections, continue to be challenging, and result in increased patient pain and discomfort, longer hospital LOS, and a higher mortality rate; thus, it is imperative to identify strategies that will minimize the risk for infection while optimizing the outcomes.23 Hernia repair and the use of biomaterials presents a higher potential for infection and, consequently, an increased recurrence rate. Studies show that although infection rates vary depending on whether procedures are open or laparoscopic, rates can be as high as 18%.24 In cases where patients are more susceptible to infection, GORE® DUALMESH® PLUS Biomaterial has been proven effective in inhibiting bacterial colonization, while maximizing rapid tissue attachment. GORE® DUALMESH® PLUS Biomaterial is the only prosthetic material for hernia repair that incorporates an antimicrobial agent within the product.17 The GORE® DUALMESH ® PLUS contains both silver carbonate and chlorhexidine diacetate, which have been shown to be bactericidal to 10 different strains of organisms including MRSA, S. epidermidis, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Candida albicans.25 Harrell et al tested MRSA resistance in 9 types of mesh, including GORE® DUALMESH ® PLUS Biomaterial,
Parietex ® Composite (polyester/polypropylene/glycol), Marlex® (polypropylene), and Composix® (ePTFE/polypropylene), and found that GORE® DUALMESH® PLUS Biomaterial was the only mesh without detectable adherence by MRSA.14 The impregnation of these agents into the biomaterial provides protection against the risk for an infection by inhibiting microbial colonization and initial biofilm formation for up to 14 days following repair.14
Clinical Evidence on Lack of Shrinkage For GORE® DUALMESH® Biomaterial GORE® DUALMESH® Biomaterial continues to be a mainstay of laparoscopic incisional and ventral hernia repairs. Yet, there has been criticism of the material in that there is a perception that it shrinks more than other materials used for this type of procedure. Recent studies have provided data on adult patients that address this misconception. Because ePTFE is the only prosthetic consistently visible using CT imaging,26 Carter and colleagues were able to measure the size of the mesh after implantation in 65 patients undergoing CT scanning following laparoscopic incisional hernia repair with GORE® DUALMESH® Biomaterial.27 It was possible to determine the actual size of the mesh after implantation using specialized software, which showed an average shrinkage rate of 7.9%.27 Similarly, Schoenmaeckers et al reported that shrinkage of ePTFE in 656 patients undergoing laparoscopic hernia repair was only 7.5% when measured by CT scan.26 Since the introduction of the ePTFE, a number of studies have outlined its characteristics and demonstrated its use for hernia repair in optimizing outcomes in different types of patients. This report will address many of the current uses of GORE® DUALMESH® Biomaterial, including parastomal hernia repair, re-operative procedures in the presence of mesh, and complex abdominal wall repairs. Certainly, there are many surgeons who do not believe that a product is better just because it is new. More importantly, however, the science as well as a product’s track record should provide guidance when selecting a prosthetic material to repair any and all hernias.
Case 1 An 85-year-old man undergoing parastomal hernia repair. Alfredo M. Carbonell, DO
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he patient had a history of invasive bladder carcinoma. Twelve years ago, the patient had undergone a radical cystoprostatectomy with an ileal conduit urinary stoma. He presented with both a midline incisional and a recurrent parastomal hernias. He had undergone 2 failed open non-mesh attempts at parastomal hernia repair in the past ( Figure 1). After discussing open and laparoscopic options, the patient chose laparoscopy. A laparoscopic Sugarbaker repair was performed. Taking into account the midline incisional defect, the hernia defect area measured 11 x 9 cm (Figure 2). The GORE® DUALMESH®
Figure 1. Computed tomographic scan image demonstrating both the parastomal and midline incisional hernia defects.
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REPORT Biomaterial was chosen for the repair as it is the most proven mesh for the laparoscopic repair of parastomal hernias, and its laminar mesh structure prevents an aggressive mesh–bowel inflammatory reaction, thus preventing bowel erosion.28 The GORE® DUALMESH® Biomaterial was trimmed to a size measuring 18 x 21 cm. Cardinal sutures were placed along the edges of the mesh and paired sutures were placed along the side of the mesh where the bowel would exit (Figure 3). The mesh was positioned against the abdominal wall using both permanent sutures and tacks (Figures 4 and 5). Total operative time was 98 minutes, and postoperatively the patient did very well and was discharged home after a 4-day hospital stay. At the 4-year follow-up, the patient remained free of cancer and without any recurrence.
Discussion The laparoscopic Sugarbaker parastomal hernia repair is a durable hernia repair option. The physical properties of GORE®
DUALMESH® Biomaterial with its laminar construction make it the safest mesh to use for this technique and this has been borne out in the clinical literature.16,28 Parastomal hernias pose a unique problem for general surgeons because unlike other types of hernias of the abdominal wall, the defect needs to be covered completely while still allowing a functional portion of the intestine to exit the abdominal wall through that very same defect. The Sugarbaker parastomal hernia repair technique accomplishes this task by positioning the mesh directly against the abdominal wall, while allowing the bowel segment to course in between the mesh and the abdominal wall. The bowel then re-enters the peritoneal cavity through a sling or shower curtain deformity between the mesh and the abdominal wall. Because the bowel essentially is draped over the edge of the mesh, the mesh has to have certain properties to avoid mesh–bowel erosion.
Conclusion For years, GORE® DUALMESH® Biomaterial has been the most consistently used type of mesh for laparoscopic incisional hernia repair as well as parastomal hernia repair, particularly,
Figure 4. GORE® DUALMESH® Biomaterial in position against the abdominal wall. Figure 2. Intraoperative photo demonstrating the parastomal hernia defect.
Figure 3. GORE® DUALMESH® Biomaterial with cardinal sutures in place prior to implant.
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Figure 5. Immediate postoperative photo demonstrating the laparoscopic incisions and the transabdominal fascial suture site incisions.
REPORT the Sugarbaker technique.28,29 GORE® DUALMESH® Biomaterial is a nonporous, laminar mesh structure, which allows for adequate mesh ingrowth, without the dense adhesions seen with other mesh types.30,31 Although the macroporous or corduroy side of the mesh is placed in direct contact with the bowel, the mesh does not erode into the bowel. Despite its many years of use, there have been no reported events of spontaneous GORE ® DUALMESH ® Biomaterial–bowel erosion as have been seen with both polyester and polypropylene-based meshes.32 Its laminar structure prevents the mesh from growing into the bowel, despite the continuous peristalsis of the bowel across the mesh edge.
Q&A Dr. LeBlanc: Do you prep the bowel in these patients? Dr. Carbonell: No. A bowel prep is traditionally used to decrease the chance of wound infection or anastomotic leaking at the time of bowel resection or reanastomosis. Not only have studies demonstrated the opposite to be true, but we also
are not opening the bowel during parastomal hernia repair. If one was to injure the bowel during the repair, it would be inadvisable to proceed with mesh implantation anyway. Hence, bowel prep is not useful. Dr. LeBlanc: How far apart are the sutures placed? Dr. Carbonell: We have traditionally used a spacing of every 5 cm or so for standard laparoscopic incisional hernia repair, the thought being that if the mesh stays where you place it, the hernia is unlikely to recur. The only way to ensure that the mesh stays where you place it is to use multiple, permanent, transabdominal fascial sutures. Dr. LeBlanc: Do you place an abdominal binder on these patients postoperatively? If so, how long do you make them wear it? Dr. Carbonell: Binders have not been shown to decrease seroma, but in some patients it helps them feel like they have support of their abdomen while they ambulate. If the binder is comfortable for them, I have these patients wear it for support for approximately 6 weeks.
Case 2 A 39-year-old man with a large recurrent midline incisional hernia. Carl R. Doerhoff, MD
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he patient was morbidly obese with a body mass index (BMI) of 40 kg/m2 (height: 68 inches, weight: 120 kg). A construction worker, the patient was on medical disability. Significant past medical history included a prior colostomy and subsequent subtotal colectomy with J-Pouch for ulcerative colitis in 1998. He reported having 15 abdominal operations with multiple attempts at hernia repair, including multiple mesh failures. In 2009, he underwent a repair using the components separation technique with polypropylene but he developed yet another recurrence. He had a second repair using the components separation technique in early 2010 using biologic mesh. Following this operation, he developed a large wound infection that was treated with damp-to-dry dressings and healed by secondary intention. When the patient was referred and first examined in July 2010, he had a large abdominal wall defect, an exceedingly thin, weeping re-epithelialized wound, and a central “mass” of contracted polypropylene measuring 2 x 8 inches. His CT scan showed a meshoma with surrounding inflammation. In August 2010, the patient underwent operation to remove the infected polypropylene and biologic mesh and excise the thin re-epithelialized skin. The patient’s midline incisional defect and left-sided colostomy hernia were closed using a No. 1 absorbable monofilament. The incision was left open; however, despite negative pressure wound therapy and dampto-dry dressings, the wound continued to have a draining sinus tract. In November 2010, the patient underwent operation to remove an infected polypropylene stitch. This time, his wound healed with damp-to-dry dressings. A follow-up CT scan showed no residual mesh or inflammation but did show an abdominal wall defect measuring 22 x 32 cm. The residual
Figure 6. Large recurrent midline incisional hernia repaired using 2 pieces of GORE® DUALMESH® PLUS Biomaterial (26 x 34 cm).
abdominal wall could not be medialized to decrease the size of his defect. Consequently, the defect had to be bridged with a piece of mesh that could withstand significant intraabdominal pressure and protect abdominal viscera. In February 2011, the patient’s hernia was repaired laparoscopically, using 2 pieces of GORE® DUALMESH ® PLUS Biomaterial, each measuring 26 x 34 cm. The first 2.5 hours of the procedure required extensive adhesiolysis. The falciform ligament was taken down and the urinary bladder was mobilized posteriorly. Outside the abdomen, the 2 pieces of GORE® DUALMESH® PLUS Biomaterial were oriented transversely, overlapping by 5 cm, and affixed to one another with 22 interrupted stitches of CV-0 GORE-TEX® Suture (Figure 6).
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REPORT Cardinal stitches of CV-0 GORE-TEX® Suture were placed at 6 locations on the mesh. The conjoined pieces of mesh were introduced into the abdomen through a 15-mm trocar site. Cardinal stitches were brought transabdominally, using a GORE® Suture Passer. The edge of the mesh was then positioned using an absorbable tacker. The caudal portion of mesh was affixed to the pubis and Cooper’s ligaments with a nonabsorbable tacker. Next, 25 transfascial CV-0 GORE-TEX® Sutures were placed circumferentially around the 2 pieces of mesh using a GORE® Suture Passer. Last, a double crown of 300 nonabsorbable tacks was placed circumferentially. All skin incisions were closed using running nonabsorbable sutures. The entire operation was completed in 5 hours. The patient had an uneventful hospital course and was discharged on postoperative day 5.
Conclusion This operation demonstrates that bridging is still a viable alternative even for the largest of multiple recurrent hernias.
Q&A Dr. LeBlanc: Do you attempt to make the obese patients lose weight prior to surgery? Dr. Doerhoff: Typically, yes. Especially if they have failed more
than one repair or if their BMI is greater than 45 kg/m2. Studies have shown that the recurrence rate in the obese population can be as high as 50%. Although some patients refuse to lose weight, a durable laparoscopic repair can be done. Dr. LeBlanc: Why did you choose the laparoscopic approach rather than an open approach to this hernia? Dr. Doerhoff: I’m not a personal fan of open repair because of increased risk for infection, seroma, and wound complications. The laparoscopic repair allows me to visualize the complete abdominal wall and identify any additional smaller hernias, as well as “Swiss cheese” defects. Therefore, I do a better job of overlapping a defect laparoscopically. Additionally, studies of incisional hernias have shown that covering the entire prior incision may reduce recurrence. Dr. LeBlanc: Do you think that the PLUS product was the ideal product for this individual and why? Dr. Doerhoff: I always feel better adding an antimicrobial barrier (silver and chlorhexidine) to the mesh in a patient who has had a previous mesh infection. Additionally, studies have shown a higher incidence of wound infections in the obese population. The antimicrobial technology has been shown to be effective against both gram-positive and gram-negative bacteria as well as MRSA for up to 14 days postoperatively.
Case 3 A 66-year-old obese woman undergoing parastomal hernia repair. Birgitta Hansson, MD he patient had a BMI of 33 kg/m2 and suffered from rheumatoid arthritis. The latter was treated with steroids. Five years ago, a Hartmann’s procedure was performed to manage acute diverticular disease with perforation and peritonitis. The patient complained of pain caused by the stretching of the abdominal wall and poor fitting of the appliance, resulting in leakage and peristomal skin irritation. Furthermore, she reported to have cosmetic problems that caused her quality of life to decrease significantly since the hernia became symptomatic. Clinical examination showed a huge parastomal hernia in the left lower abdomen. The hernia could not be reduced. A CT scan was performed to measure the hernia and rule out concomitant incisional hernias because these could not be palpated at clinical examination. The results showed a hernia of more than 5 cm with herniation of the small bowel and an incisional hernia in the lower abdomen (Figure 7). Because of her growing complaints, a laparoscopic approach was determined to be optimal, and both hernias were repaired using 2 separate pieces of GORE® DUALMESH® Biomaterial. The parastomal hernia was repaired using the Sugarbaker technique, by which the mesh covered the hernia opening with an overlap of 4 cm on each side once the stoma loop was lateralized. The double crown technique was used for the incisional hernia. The postoperative course was uneventful. Figure 8 shows the postoperative result after the Sugarbaker technique.
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Discussion A parastomal hernia is a common complication after stoma formation. Risk factors are obesity, chronic cough, or when the created size of the stoma opening is too wide. A symptomatic parastomal hernia can be treated by relocating the stoma, or by local reinforcement of the abdominal wall with a prosthetic mesh. Stoma relocation involves relaparotomy and replacement of the stoma to the contralateral side. In addition to the risk for developing an incisional hernia at the midline or at the old ostomy site (20%-30% of all cases), this technique carries a recurrence rate of up to 36%.33,34 Mesh repair has a lower recurrence rate. Depending on technique and placement, recurrence rates vary between 6.9% and 17.8%, and the overall mesh infection rate is 2.3%.28 The mesh can be placed in an onlay, retromuscular, or intraperitoneal position, either by laparoscopy or open approach. A review of the literature finds no significant advantage of one approach over the other, while randomized controlled trials have proven to be lacking.28 The laparoscopic approach is safe and feasible and causes minimal damage to the insufficient abdominal wall.35 GORE® DUALMESH® Biomaterial is used to reinforce the abdominal wall. GORE® DUALMESH® Biomaterial is the most often used prosthetic material in parastomal hernia surgery because it is soft and pliable and easy to handle. It results in less severe adhesions to the viscera compared with polypropylene meshes.16 If adhesions occur, the bowel can easily be dissected free from the prosthesis.11 A potential drawback of
REPORT
Figure 7. Preoperative CT scan of obese patient with parastomal hernia. GORE® DUALMESH® Biomaterial is risk for infection.13 In the only prospective series reporting on the laparoscopic repair of 55 parastomal hernias with an ePTFE patch, prosthetic infection was found in 3.6%.35 Once the mesh is infected, it should be removed. In general, infection of the mesh is not a major issue in a laparoscopic ventral or parastomal hernia surgery because it is considered to be a clean operation. Although when a bowel injury with fecal spill occurs, we recommend postponing mesh implantation for at least 6 weeks.
Conclusion When performing a parastomal hernia repair, surgeons can use a mesh with or without a slit. The former technique also is called the “keyhole technique.” Unfortunately, this technique has a high recurrence rate caused by progressive widening of the central keyhole. Recurrence rates of more than 30% have been reported.28,36 In 1985, Sugarbaker described the non-slit technique by which a mesh is used to cover the hernia opening with an overlap of 4 cm on each side, after the stoma loop is lateralized (Figure 8).37 A considerably lower recurrence rate of 11.6 % was reported.28 Recently, the use of biologic grafts in parastomal hernia repair has been published. Review of the literature, however, does not show better outcomes with the more expensive biologic materials.38
Figure 8. Postoperative CT scan with ePTFE patch. Therefore, the Sugerbaker technique with GORE ® DUALMESH® Biomaterial is an effective technique.
Q&A Dr. LeBlanc: Do you ever use transfascial sutures for these procedures? If so, when do you decide to do so? Dr. Hansson: Yes, I always use 2 nonresorbable sutures (Prolene 2.0) at the most lateral border of the mesh, at the left and right side of the “lateralized” bowel. Besides this, the mesh is fixed with titanium tacks (ProTack). Dr. LeBlanc: Do you make an attempt to close the hernia defect in these cases? Dr. Hansson: Nowadays, I don’t close the defect anymore. I did in my study on the keyhole technique and after a while we noticed that the sutures disrupted. Since then, I prefer a tension-free repair. In the study, we operated on 55 consecutive patients with a symptomatic parastomal hernia using the keyhole technique (see also references). We closed the defect using a non-resorbable suture 0. We reoperated on 9 out of 55 patients because of a recurrent symptomatic hernia. During reoperation, we found that the sutures were disrupted and the mesh was everted due to the high intraabdominal pressure. We concluded that suturing the defect only has temporary result, after a while sutures disrupt. That’s why we believe that a tension-free repair is best.
Case 4 A 62-year-old woman with cirrhosis and massive hepatitis C virus–related (Child B) ascites undergoing intraperitoneal incisional hernia repair. Antonio Iuppa, MD
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he patient underwent colon resection for a perforation resulting from diverticulitis 10 years ago. She developed a giant incisional hernia with skin ulceration and high risk for spontaneous evisceration (Figure 9). On admission to the hospital, the patient’s bilirubin and albumin levels were 2.5 mg/dL and 2.8 g/dL, respectively. The antithrombin III level was normal, and there was no previous history of bleeding.
Initial management included sterile occlusive dressing, fluid repletion, and antibiotic administration. The attempt to reduce ascites with medications failed. A peritoneovenous shunt was implanted 1 week before the repair with satisfactory results with a significant reduction of the ascites. The initial plan was to perform a suprafascial extraperitoneal repair in order to avoid the opening of the peritoneum; however, the preservation of the peritoneum was impossible thus requiring an intraperitoneal approach. The procedure started
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REPORT
Figure 9. Preoperative CT scan showing the ascites and the hernia.
with the creation of a plane between the muscular fascia and the subcutaneous tissue so that the mattress stitches would not have to pass through the skin. The hernia sac was opened but not resected so that it could cover the mesh at the end of the operation. A posterior plane was created on the posterior face of the abdominal wall, detaching the adhesions, the falciform ligament, and the bladder. Once this posterior support area was created, the size of the defect was measured. It was determined that the prosthesis should be 4 to 5 cm larger than the defect, enabling gentle retraction of the margins without causing excessive tension. In this case, the GORE速 DUALMESH速 PLUS Biomaterial, measuring 26 x 36 cm, was used to avoid leakage of ascitic fluid. The fixation of the mesh was performed with nonresorbable monofilament material. The suture was passed in U-shape from the abdominal wall to the mesh about 4 cm from the margin of the defect, covering the entire circumference of the defect. After ensuring that the tension was uniform across the entire mesh, the residual hernial sac covered the mesh using interrupted reabsorbable stitches. This step separated the mesh from the subcutaneous tissue and supported the migration of fibroblasts into the mesh (Figure 10). The patient had an uneventful recovery except for the appearance of a subcutaneous hematoma that did not require surgical intervention.
Conclusion One of the most challenging situations in patients with incisional hernias is the presence of cirrhosis and ascites. Abdominal wall repair in a patient with advanced cirrhosis presents an operative risk of great magnitude and may pose a considerable technical problem when complicated by the leakage of ascitic
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Figure 10. Postoperative CT scan showing the position of the mesh and the shunt.
fluid, necrosis of the abdominal wall with ulceration, rupture, strangulation, or infection. Management of umbilical hernias in patients with cirrhosis and ascites remains difficult as these patients often have advanced liver disease and are at greater risk for complications following any surgical intervention. Elective surgical repair prevents complications, whereas morbidity after emergency surgery is up to 30%.39-41 Repair should be performed after optimal management of ascites, which includes fluid and salt restriction, diuretics, and possibly undergoing a transjugular intrahepatic portosystemic shunt procedure before surgery, if the ascites are difficult to control with medical therapy.
Q&A Dr. LeBlanc: What type of antibiotic coverage did you administer to this patient? Dr. Iuppa: I administered vancomycin hydrochloride (2 g daily for 3 days), a nonabsorbable antibiotic that is effective against anaerobic gram-negative rods. It is useful in controlling portal systemic encephalopathy in patients with cirrhosis. It also has been shown that changes in blood ammonia concentrations correspond very well with changes in the number of anaerobic gram-negative rods in feces. Dr. LeBlanc: Are the antimicrobial agents in the PLUS material essential in cases such as this one? Dr. Iuppa: The GORE速 DUALMESH 速 PLUS Biomaterial is the only 2-sided, prosthetic material with antimicrobial agents (chlorhexidine and silver) that act synergistically to inhibit bacterial colonization and resist initial biofilm formation on the biomaterial for up to 14 days following implantation. This is of great importance when used in immunodepressed or debilitated patients such as those with cirrhosis.
REPORT
Case 5 A 48-year-old man undergoing continuous ambulatory peritoneal dialysis after ventral hernia repair. Srdjan Rakic, MD, FACS
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he patient had undergone open sublay repair of a midline suprapubic incisional hernia using a polypropylene mesh (15 x 10 cm), and a laparoscopic repair of a large incisional hernia at midline incision using GORE® ® DUALMESH Biomaterial measuring 20 x 30 cm.42 Because the patient refused hemodialysis and kidney transplantation was not an option given the patient’s poor vascular status, continuous ambulatory peritoneal dialysis (CAPD) was indicated.42 Being aware of the potential risk for infection, it was essential to avoid compromising the GORE® DUALMESH® Biomaterial while inserting the CAPD catheter. A CT scan was used to determine the precise position of the mesh (Figure 11) and, consequently, to preoperatively draw a sketch of the mesh on the abdominal wall of the patient (Figure 12). With the mesh outlined, the CAPD catheter was implanted laparoscopically using 2 trocar ports that were positioned left laterally in the abdomen, while avoiding the GORE® DUALMESH® Biomaterial.42 Intraoperatively, the mesh was completely covered with intact neoperitoneum and omental adhesion.42 The procedure was carried out uneventfully. During the next 2 years, the patient experienced occasional episodes of CAPD-related peritonitis, requiring removal (3 times) or reinsertion (2 times) of the catheter.42 The latter procedures were performed using the same technique as the initial insertion of the CAPD catheter: left or right (Figure 13). In all instances, the mesh was left undisturbed and remained uninfected.
Conclusion This case highlights the importance of a radiopaque mesh for subsequent insertion of a catheter for CAPD. Abdominal surgery after laparoscopic ventral or incisional hernia repair (LVHR) can be challenging and requires careful planning and
Figure 11. Preoperative CT scan showing position of the mesh.
execution. A detailed preoperative assessment of the position and size of the previously implanted mesh is highly desirable. ePTFE mesh has the unique property of being revealed by CT scan due to its density and structure. Reoperations in patients with a previous LVHR carry a risk for mesh contamination and infection. Therefore, it is imperative to avoid an incision through a mesh or coming into contact with it whenever possible, in order to minimize the risk for contamination. In this specific case, the ability to radiologically visualize the existing mesh provided the ability to safely insert a CAPD catheter 3 times and at 3 different sites, despite only having access to a relatively small portion of the abdominal wall during the procedure.
Q&A Dr. LeBlanc: Is it true that this is the only product that is truly “visible” on CT scans? Dr. Rakic: Yes. Visibility of meshes or the property of being revealed by high-resolution imaging techniques such as CT or MRI is determined by 2 factors: predominantly by specific properties of mesh itself and, to a lesser degree, by a host inflammatory reaction generated by implanted prosthesis. The most important properties of a mesh that determine its radiologic visibility are the density, structure, and thickness of the material used to produce a mesh. The only meshes that are always visible are GORE® DUALMESH® and GORE® DUALMESH® PLUS because of the high density of the material (ePTFE), its homogenous structure (nonwoven/not knitted), and its thickness (1, 1.5, or 2 mm). This feature allows for very precise and reliable measurements of mesh dimensions, position, and overlap.
Figure 12. Preoperative sketch of the mesh on the abdominal wall of the patient.
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REPORT The visibility of composite meshes containing ePTFE component (Composix, Ventralex, Intramesh T1, Dulex) is less consistent: Because the ePTFE component is much thinner (≤0.20 mm, they sometimes are clearly visible, whereas at other times they are not. As a general rule, these meshes easily can remain unrecognized when not specifically sought after and vice versa. Less reliable and less consistent visibility of these meshes do not allow for precise radiologic measurements compared with the first group. All other meshes in general are not visible due to their isoattenuity relative to surrounding structures. Indirect evidence of mesh presence occasionally can be recognized, especially with MRI, due to the intense inflammatory response surrounding and incorporating the mesh (eg, scar tissue, meshoma). However, precise and reliable measurements of mesh dimension, position, and overlap are impossible. Dr. LeBlanc: In your mind, does the fact that this material did not become infected despite the episodes of peritonitis prove that there is no more susceptibility to infection with this material compared with other prosthetic materials? Dr. Rakic: Possibly. I assume that every mesh placed into the abdominal cavity will be covered with some sort of neoperitoneum within a relatively short period. Complete neoperitonealization of mesh might well be crucial in protection against mesh infection. If this is really true, it is probably irrelevant as to which mesh is lying under neoperitoneum.
Figure 13. Plain x-ray of the abdomen showing the continuous ambulatory peritoneal dialysis catheter introduced on the right side of the abdomen. Tacks used for fixation of the mesh also are visible.
Case 6 Two patients undergoing giant abdominal wall desmoid resection and abdominal wall reconstruction. Songzhang Ma, MD
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31-year-old woman was diagnosed as having a giant desmoid tumor measuring 25 cm in diameter infiltrating the thickness of the abdominal wall (Figure 14). A complete tumor excision was performed and the abdominal wall was reconstructed using GORE® DUALMESH® Biomaterial measuring 20 x 30 cm (Figure 15). A 25-year-old woman had undergone an abdominal wall desmoids resection 3 years prior to reoperation. Myocutaneous
Figure 14. A giant desmoid measuring 25 cm in diameter infiltrating the thickness of the abdominal wall.
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flaps covered the defect. The tumor was recurrent in situ from the previous year and quickly developed a mass measuring 12 cm in diameter (Figure 16). The tumor was resected carefully and completely, and the abdominal wall was reconstructed using GORE® DUALMESH® Biomaterial measuring 18 x 24 cm (Figure 17). GORE® DUALMESH® Biomaterial was secured to the deep fascial elements using interrupted 1-0 Prolene sutures, and subcutaneous closed suction drains were placed. With both patients, the procedures were done successfully. The postoperative period of both patients was uneventful and without any serious complications (eg, seroma or infection).
Figure 15. GORE® DUALMESH® Biomaterial was used to reconstruct the abdominal wall.
REPORT
Figure 17. GORE® DUALMESH® Biomaterial is used to reconstruct the abdominal wall with interrupted 1-0 Prolene sutures.
Figure 16. A recurrent desmoid tumor 3 years prior to reoperation. Postoperative treatment included sulindac 200 mg twice daily and tamoxifen 20 mg daily. At the 24-month follow-up, there was no desmoid recurrence on the abdominal wall. Inspiration and expiration tests were used to measure the patients’ abdominal wall compliance, and the results showed that the abdominal wall was functioning well without any feeling of stiffness in both patients. At 6 months, however, a CT scan indicated a newly developed tumor on the mesentery in the 25-year-old patient.
Conclusion GORE® DUALMESH® Biomaterial was selected for abdominal wall reconstruction based on its following features considered ideal for the repair: • • • • •
Mesh pliability and compliance Tensile strength Biocompatibility Minimal adhesion with tissue and organs to the material Firm tissue attachment and ingrowth
Superficial desmoid tumors should be resected before they become large. The reconstruction of the abdominal wall with large soft tissue defects is usually very complicated and can be performed immediately using myocutaneous flaps or synthetic meshes. Because positive margins were associated with a 2-fold increased risk for local tumor recurrence, additional resection on surrounding tissue should be completed. Pathologic examination of the specimens of our patients confirmed
the presence of 2 to 3 cm margins of normal tissue around the tumor.
Q&A Dr. LeBlanc: How long were the drains left in place? Dr. Ma: The time at which to pull the drainage tube is determined by the amount of drainage. If drainage is less than 20 mL per day, it can be considered. In case 1, the drainage tube was retained for 7 days. In case 2, it was retained for only 3 days. Because of the large surgical wound, tube retainment depends on the clinical signs. After pulling the tube out, an ultrasound or CT scan may be necessary. If any fluid remains in the abdominal cavity around the mesh, additional treatment may be required. In case 1, a CT scan showed a small amount of fluid but did not require further treatment. Dr. LeBlanc: If you have to reoperate on patients such as these, what do you recommend for closure of the DUALMESH®? Dr. Ma: This is a good question. In my opinion, if abdominal surgery is required, the conventional method to open and close the abdominal wall is acceptable. If the reoperation is for recurrence of tumor, removal of the tumor is performed first, and then repair the subsequent abdominal defect with a new mesh. It is easy to separate the adhesion between the GORE® DUALMESH® Biomaterial and the organ surface; the healed area with mesh in the abdominal wall can still be closed by using continuous sutures.
References 1.
Zografos GN, Mitropapas G, Vasiliadis F, et al. Open and laparoscopic approach in incisional hernia repair with ePTFE prosthesis. J Laparoendosc Adv Surg Tech A. 2007;17(3):277-281.
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Matthews BD, Pratt BL, Pollinger HS, et al. Assessment of adhesion formation to intra-abdominal polypropylene mesh and polytetrafluoroethylene mesh. J Surg Res. 2003;114(2):126-132.
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W.L. GORE & Associates, Inc. GORE DUALMESH Biomaterial. Flagstaff, AZ. 2010.
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W.L. GORE & Associates, Inc. GORE-TEX soft tissue patch. http:// www.GOREmedical.com/stp. Accessed April 3, 2012.
Novitsky YW, Harrell AG, Cristiano JA, et al. Comparative evaluation of adhesion formation, strength of ingrowth, and textile properties of prosthetic meshes after long-term intra-abdominal implantation in a rabbit. J Surg Res. 2007;140(1):6-11.
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LeBlanc KA, Bellanger D, Rhynes KV 5th, Baker DG, Stout RW. Tissue attachment strength of prosthetic meshes used in ventral and incisional hernia repair. A study of the New Zealand White rabbit adhesion model. Surg Endosc. 2002;16(11):1542-1546.
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W.L. GORE & Associates, Inc. Proprietary ePTFE technology from GORE. http://www.GORE.com/en_xx/products/venting/packaging/eptfe_membrane.html. Accessed April 3, 2012.
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Bauer JJ, Salky BA, Gelernt IM, Kreel I. Repair of large abdominal wall defects with expanded polytetrafluoroethylene (PTFE). Ann Surg. 1987;206(6):765-769.
“Material Matters” in Surgery. http:www.GOREmedical.com/newsletters/clsoing-remarks/issue-6/featured-topic.html. Accessed April 4, 2012.
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REPORT 10. Burger JWA, Luijendijk RW, Hop WCJ, Halm JA, Verdaasdonk GG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004;240(4):578-585. 11. Wassenaar EB, Schoenmaeckers EJP, Raymakers JFTJ, Rakic S. Subsequent abdominal surgery after laparoscopic ventral and incisional hernia repair. Hernia. 2010;14(2):137-142. 12. Koehler RH, Begos D, Berger D, et al. Adhesion formation to intraperitoneally-placed mesh: reoperative clinical experience after laparoscopic ventral incisional hernia repair. JSLS. 2003; 7(4):335-340. 13. Bleichrodt RP, Simmermacher RK, van der Lei B, et al. Expanded poly-tetrafluoroethylene patch versus polypropylene mesh for the repair of contaminated defects of the abdominal wall. Surg Gynecol Obstet. 1993;176(1):18-24. 14. Harrell AG, Novitsky YW, Kercher KW, et al. In vitro infectability of prosthetic mesh by methicillin-resistant Staphylococcus aureus. Hernia. 2006;10(2):120-124. 15. A legacy of innovation in hernia repair: CORDUROY tissue ingrowth surface. GORE DUALMESH Plus. Flagstaff, AZ: W.L. GORE & Associates, Inc.; 2007. 16. Simmermacher RK, Schakenraad JM, Bleichrodt RP. Reherniation after repair of the abdominal wall with expanded polytetrafluoroethylene. J Am Coll Surg. 1994;178(6):613-616. 17. Cobb, WS, Kercher, KW, Matthews, et al. Laparoscopic ventral hernia repair: a single center experience. Hernia. 2006;10(3): 236-242. 18. LeBlanc KA. A new method to insert the DUALMESH prosthesis for laparoscopic ventral herniorrhaphy. JSLS. 2002;6:349-352. 19. Boyce B. Physical characteristics of expanded polytetrafluoroethylene grafts. (Stanley JC, ed). In: Biological and Synthetic Vascular Prostheses. New York: NY: Grune and Stratton; 1982:553-561. 20. Wassenaar EB, Schoenmaeckers EJ, Raymakers JT, Rakic S. Recurrences after laparoscopic repair of ventral and incisional hernia: lessons learned from 505 repairs. Surg Endosc. 2009;23(4):823-832.
after laparoscopic ventral incisional hernia repair with an expanded polytetrafluoroethylene mesh. Surg Endosc. 2009;23(7):1620-1623. 27. Carter PR, LeBlanc KA, Hausmann MG, Whitaker JM, Rhynes VK, Kleinpeter KP, Allain BW. Does expanded polytetrafluoroethylene mesh really shrink after laparoscopic ventral hernia repair? Hernia. 2012;16(3):321-325. 28. Hansson BM, Slater NJ, van der Veldon, et al. Surgical techniques for parastomal hernia repair: a systemic review of the literature. Ann Surg. 2012;255(4):685-695. 29. Carlson MA, Frantzides CT, Shostrom VK, Laguna LE. Minimally invasive ventral herniorrhaphy: an analysis of 6,266 published cases. Hernia. 2008;12(1):9-22. 30. Matthews BD, Mostafa G, Carbonell AM, et al. Evaluation of adhesion formation and host tissue response to intra-abdominal polytetrafluoroethylene mesh and composite prosthetic mesh. J Surg Res. 2005;123(2):227-234. 31. Jenkins ED, Yom V, Melman L, et al. Prospective evaluating of adhesion characteristics to intraperitoneal mesh and adhesiolysisrelated complications during laparoscopic re-exploration after prior ventral hernia repair. Surg Endosc. 2010;24(12);3002-3007. 32. Foda M, Carlson MA. Enterocutaneous fistula associated with ePTFE mesh: case report and review of the literature. Hernia. 2009;13(3):323-326. 33. Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003;90(7):784-793. 34. Allen Mersh TG, Thomson JP. Surgical treatment of colostomy complications. Br J Surg. 1988;75(5):416-418. 35. Hansson BM, de Hingh IH, Bleichrodt RP. Laparoscopic hernia repair is safe and feasible: early results of a prospective clinical study including 55 consecutive patients. Surg Endosc. 2007;21(6):989-993. 36. Hansson BM, Bleichrodt RP, de Hingh IH. Laparoscopic parastomal hernia repair using a keyhole technique results in a high recurrence rate. Surg Endosc. 2009;23(7):1456-1459. 37. Sugarbaker PH. Peritoneal approach to prosthetic mesh repair of parastomy hernias. Ann Surg. 1985;201(3):344-346.
21. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000;343:392-398.
38. Slater NJ, Hansson BM, Buyne OR, Hendriks T, Bleichrodt RP. Repair of parastomal hernias with biological grafts: a systematic review. J Gastrointest Surg. 2011;15(7):1252-1258.
22. Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years’ experience with 850 consecutive hernias. Ann Surg. 2003;238(3):391-399; discussion 399-400.
39. Carbonell AM, Wolfe LG, DeMaria EJ. Poor outcomes in cirrhosis-associated hernia repair: nationwide cohort study of 32,033 patients. Hernia. 2005;9(4):353-357.
23. Engemann JJ, Carmeli Y, Cosgrove SE, et al. Adverse clinical and economic outcomes attributable to methicillin resistance among patients with Staphylococcus aureus surgical site infection. Clin Infect Dis. 2003;36(5):592-598.
40. Choi SB, Hong KD, Lee JS, et al. Management of umbilical hernia complicated with liver cirrhosis: an advocate of early and elective herniorrhaphy. Dig Liver Dis. 2011;43(12):991-995.
24. Rios A, Rodriguez JM, Munitz V, Alcaraz P, Pérez Flores D, Parilla P. Antibiotic prophylaxis in incisional hernia repair using a prosthesis. Hernia. 2001;5(3):148-152. 25. W.L. GORE & Associates, Inc. GORE DUALMESH Plus Biomaterial. Flagstaff, AZ. 2010. 26. Schoenmaeckers E, van der Valk S, van den Hout H, Raymakers JF, Rakic S. Computed tomographic measurements of mesh shrinkage
41. Ahmad TAA, Ali SM, Zaghloul N, El-Minshawy O. Complicated umbilical hernia in cirrhotic patients with ascites. Egyptian J Surg. 2004;23(2):167-171. 42. Schoenmaeckers E, Woittiez AJ, Raymakers J, Rakic S. Continuous ambulatory peritoneal dialysis after intra-abdominally placed synthetic mesh for ventral hernia repair. J Laparoendosc Adv Surg Tech A. 2011;21(8):741-743.
Financial Disclosures:
This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, GORE, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2012, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.
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Disclaimer: Gore products referenced within, if any, are used within their FDA approved/cleared indications. Gore does not have knowledge of the indications and FDA approval/clearance status of non-Gore products. Gore makes no representations as to the surgical techniques, medical conditions or other factors that may be described in this article. The reader is advised to contact the manufacturer for current and accurate information. AQ0106-EN1
RP1564
Dr. LeBlanc reported that he is a consultant and on the speakers’ bureau for W.L. GORE, CR Bard, and Covidien. He also is on the medical advisory board for Via Surgical. Dr. Carbonell reported that he is a consultant and on the speakers’ bureau for W.L. GORE and a consultant for Ethicon Endo-Surgery and Bard Davol. Dr. Doerhoff reported that he is on the speakers’ bureau for W.L. GORE, Ethicon Endo-Surgery, and Covidien. Drs. Hansson, Iuppa, Rakic, and Ma reported no relevant financial conflicts of interest.