July 2013 by McMahon Group

GENERALSURGERYNEWS.COM

July 2013 • Volume 40 • Number 7

The Independent Monthly Newspaper for the General Surgeon

Opinion

REUTERS/Jessica Rinaldi

CMS Directives: Hat or Miss B Y L AUREN A. K OSINSKI , MD, MS

n response to deficiencies reported by the Centers for Medicare & Medicaid Services (CMS), following a recent survey of my hospital, the operating room administration mandated that the traditional surgeon’s cap (referred to in that correspondence as a “skullcap”) could be worn no longer. Only disposable bouffant caps provided by the hospital would be acceptable attire, and all surgeons’ caps were removed from hospital procedural areas. Surgeons (male and female alike) were dumbfounded. The rollout of the new hat policy offered no scientific evidence to justify the decree.

A surgical icon, the skull cap signifies ‘surgeon.’ This rule affected more than physicians, but nonetheless was received as just one more of the rapidly proliferating, apparently capricious rules governing physician performance, reinforcing the perception that we are being policed by administrators and nurses to prevent us from harming our patients. This new mandate struck a nerve: Wiping out a surgical icon—the long white coat and scrubs signify “doctor,” but the skullcap signifies “surgeon.” Not only that, the comfort of the familiar was jettisoned without warning. Somehow this chafes, because despite earning a decent see HAT OR O MISS SS page 28 8

Lessons Learned in Boston B Y B RIGID D UFFY

he morning of April 15, 2013 started as a typical Marathon Monday for Dr. Tim Lepore. At age 68, Nantucket’s only surgeon laced up his trainers and made his way to the starting line of his 45th consecutive Boston Marathon. By mid-morning, long after the elites’ dust had settled, Dr. Lepore joined the second and third waves of runners who crossed the starting line

on Hopkinton Massachusetts’ Main Street. The air was a cool 50 degrees. The sky was overcast with an occasional spot of sunlight that added brilliance to the outstretched road ahead. All in all, it was idyllic conditions for Dr. Lepore and the 26,383 other entrants who set out to compete in the 117th Boston Marathon. Months of training had been logged, see BOSTON page 8

The ‘Cowboys’ of Lap Chole The Story of a Laparoscopic Revolution in the United States B Y V ICTORIA S TERN

n June 22, 1988, J. Barry McKernan, MD, PhD, called the surgical floor of Promina Kennestone Hospital in Marietta, Ga., where he was the trauma director, to check on his patient, a minister’s wife. A nurse whom he had worked

with for 20 years answered the phone. “Look, McKernan,” she said, “I’ve got a patient in Room 31 and she’s got four or five Band-Aids on her belly. She said you took out her gallbladder; what’d you really do?” Dr. McKernan had, in fact, performed the first laparoscopic cholecystectomy in the United States, an

INSIDE In the News _________________________

5 7

The Surgical Declaration of Independence

TNF Blockers Fail To Aid Stoma Reversal in Patients With Crohn’s

‘Watchful Waiting’ for Inguinal Hernia Safe, but Surgery Ultimately Likely

On the Web

O nthe

On the Spot with Colleen Hutchinson: Controversial Topics in Breast Cancer

Spot

Find article at: www.generalsurgerynews.com

see LAP CHOLE page 16

Group Identifies Risk Factors for Ventral Hernia Site Occurrences B Y C HRISTINA F RANGOU

risk assessment model has found several modifiable intraoperative practices that increase risk for surgical site occurrences after open ventral hernia repair. These practices include use of skin flaps, single-stage repairs for hernias that are actively infected and improper placement of mesh. “High-risk patients undergoing complex ventral hernia repairs are probably enduring one of the hardest and most difficult surgeries that they will ever experience in their lives,” said senior author Mike Liang, MD, assistant professor of surgery, Baylor College of Medicine, Houston. “Patients in this high-risk group may benefit from a modified surgical technique.” Rachel Berger, a student for a master of public health degree, presented the findings at the 2013 annual meeting of the Surgical Infection Society, held in Las Vegas. This is one of the first studies to address the incidence and risk factors, see VENTRAL HERNIA page 30

SPECIAL REPORT Improving Outcomes in Open Colorectal and Gynecologic Procedures Using the LigaSure Impact™ Instrument see INSERT AT page 16

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

To the 2013 Graduating Chief Surgical Resident Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

ou thought this day would never come. When you walked into your hospital as an intern five, six, seven or more years ago, it seemed inconceivable that you would be finally finishing your chief resident year and now ready to embark on the process of being a “real surgeon.” Now that the graduating dinner, chief ’s roast and additional hoopla are behind you, you can finally exhale and think about the issues that you will face in the coming years. If you are in the majority (70% of your graduating colleagues), you are off to begin a fellowship in a specialty that will hopefully give you many years of pleasure and deepen your commitment to your practice. You probably chose a discipline—whether colorectal, plastics, vascular, trauma/surgical critical care, etc.—because it represents a defined body of knowledge in which you wish to refine your skills, or it may hold promise for a lifestyle that fits you well and

serves the needs of your loved ones. For the 30% of your graduating cadre that will embark on general surgical practice, it will probably be a challenging transition because residency has only begun to prepare you for the experiences and responsibilities that you will face during the next 30 or more years of your career. The mandates of the Accreditation Council for Graduate Medical Education [ACGME] that have henceforth protected your time will no longer provide sanctuary. Having finished residency, you will have to deal with the issues of continuity of care. You will have to negotiate relationships with partners who ostensibly share patient responsibilities with you but may have differing agendas and interpretations of that agreement. You will have to learn the business aspects of surgery even though the practice environment is transforming such that most of you will not run your own office or hire your own personnel. Like most of your fellow graduates, you will work for a hospital or other form of health care enterprise upon graduation or in the future. Your knowledge base, which is broad and deep at the end of your residency, will be honed, especially over the

next couple of years as you prepare for and take the qualifying and certifying examinations of the American Board of Surgery. Remember that you will have to continually add to this knowledge base, and I encourage you not to let your thirst for education become quenched anytime soon. This holds the promise of renewing your interest and maintaining the vibrancy of your endeavor. So what can I tell you, a bright, energetic graduating chief surgical resident in your early to mid-30s, that you do not already know? The first thing is to not take yourself too seriously. This is a bit of a conundrum because you will have serious responsibilities, but it is important to remember that everyone can be replaced. As Charles de Gaulle said, “the cemetery is full of indispensable people.” The humility of this stance will offer you some shelter from the burdens of the commitments you will make to your patients and from reckoning with your own imperfection. The second thing is to be kind to everyone with whom you come into contact in the hospital setting. This includes your fellow physicians, nurses, residents, administrative personnel and those who

keep the hospital running and clean although we do not see them every day. Strive to view things from their perspective, and please find the capacity to forgive those who sometimes make mistakes. You will not be perfect every day, and your generosity of spirit will be remembered by those who witness your shortcomings! Third, learn to talk with your patients and explore those important issues in their lives that may be more significant than the specific reason for which they sought your care. Remember that you are in a unique position to listen to many concerns that most people are unwilling to tell anyone, even their closest loved ones. You still need to earn the privilege of being a counselor to your patients every day; this is not something that is innate, but rather an art to be perfected over many years. You will be busy in your practice now or after you finish your fellowship, but try not to neglect spending time with family. And try not to be so intense that you forget the central concerns of life. Organize your time well. This includes setting time aside for journal reading and education, see GRADUATION PAGE 4

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INFECTIOUS DISEASE SPECIAL EDITION

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

Group Presents Experience With Duodenal Bypass Liner for Weight Loss Glycemic Control, Not Diabetes Status, Seen as Key Predictor of Success B Y M ONICA S MITH BALTIMORE—In obese patients who receive a duodenal-jejunal bypass liner (DJBL), glycemic control may be a more significant predictor of successful weight loss than the presence or absence of type 2 diabetes, according to recently presented research. A DJBL is a highly flexible, nutrient-impermeable, 60-cm sleeve placed endoscopically that covers the entire duodenum and the first portion of the jejunum. “After one year of treatment, patients with a DJBL lose an average of 47% of their excess weight. However, as with bariatric surgery, weight loss is variable with this device,” said Rodrigo Munoz, MD, PhD, Departamento de Cirugia Digestiva, Escuela de Medicina, Pontificia, Universidad Catolica de Chile, in Santiago, Chile. “The aim of this study was to identify clinical predictors of weight loss in this group of patients treated with this device for one year.” The study was presented at the 2013 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. Seeking a correlation between baseline variables and weight loss, Dr. Munoz and his colleagues collected data every month for one year on 61 patients treated with a DJBL. The collected variables included demographic

information, baseline comorbidities, and anthropometric and biochemical characteristics. The majority of the patients were women, with an average age of 35 years and average body mass index of 43 kg/m2. Twenty-one of the patients (34%) had type 2 diabetes. At one year, the average percentage of excess body weight loss was 47%, with some patients at either extreme, having lost little of their excess weight or almost all of it. Coincidentally, nine patients (14.7%) lost more than the average, and nine lost less than the average. “Our univariate analysis indicated three variables inversely associated with weight loss at one year: insulin resistance determined by HOMA [homeostatic model assessment], fasting glycemia and Hb [hemoglobin]A1c,” Dr. Munoz said. “But after we controlled for all these three variables, only HbA1cc was inversely and independently associated with the weight loss effect of this device.” In contrast with previous studies, the presence of type 2 diabetes did not affect the weight loss effect of the DJBL. Dr. Munoz concluded that placement of a DJBL can result in significant weight loss in both patients with and without type 2 diabetes, and that patients with higher baseline levels of HbA1cc could benefit from early intervention to optimize the weight loss effect of this device. Dr. Munoz also said that the baseline levels of HbA1cc in the group of patients with type 2 diabetes averaged 6.7%,

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“I would be interested to know how many of the diabetics were no longer diabetic after a year.” —Jon Gould, MD which indicated good glycemic control and HbA1cc levels in the patients without type 2 diabetes averaged 6%. A larger trial could yield different results. “The differences in baseline HbA1c between diabetic and nondiabetic patients are not great, and I suspect that this relationship may disappear in a prospective trial with more patients,” said Jon Gould, MD, chief, Division of Surgery, Alonzo P. Walker Chair in Surgery and associate professor of surgery, Medical College of Wisconsin in Milwaukee. “The demographics of the study group suggest these patients would otherwise have been candidates for bariatric surgery. The mean weight loss seems pretty good for an entirely endoscopic procedure using an implantable device, so I think

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it is notable that the weight loss was so good,” Dr. Gould said. “I would be interested to know how many of the diabetics were no longer diabetic after a year.” Dr. Munoz and his team are currently analyzing several gutderived peptides and important metabolites involved in body weight and glucose regulation from blood samples obtained in a fasting condition and after a standard meal test of DJBL recipients. The samples will be taken monthly for a year. “This new set of data will help us to have a better understanding of how this device impacts a patient’s physiology, and how these changes correlate with weight loss and metabolic outcomes,” Dr. Munoz said.

GRADUATION

jContinued from page 3 but also time to spend with your spouse, your children and others who are important to you and help you maintain your frame of mind. If you’re lucky enough to have your parents, always remember to give them time and return the love they showed to you over the years as they supported you throughout your education. Use modern technology to stay in touch; FaceTime, Skype or texting those who you love and cherish on a frequent basis. Find time to spend with friends. Pick a time to go out together for a meal or to unwind from your daily activities. Although you are busy trying to carve out your new practice and make a life for you and your family, always remember the importance of being involved in some medical or surgical organization. These associations will reward you manifold over the years by allowing you to share your experiences with colleagues and enjoy the wonderful camaraderie that residency engendered. Also, remember the importance of being charitable, and try to support those important institutions and philanthropic groups that, along with you, make the world a better place. In closing, I am envious of your position and the opportunities you have ahead of you over the next several decades. Use your time wisely. Make every day count. Do not fret over and resist all the wonderful changes and opportunities that the future will bring, especially in health care. Hopefully, after the next few decades have passed, you will take the time to reflect on your experience and have your own words of wisdom to share in a letter to a new generation of graduating surgical chief residents. I would love to have a copy!

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

In Operating Room 4, JULY 4, 2013 The Unanimous Declaration of Classically Trained Surgeons of the United States of America When in the Course of surgical events it becomes necessary for one group of surgeons to dissolve the educational bands which have connected them with another and to assume among the powers of the earth, the separate and equal station to which the Principles of Surgery and of Common Sense entitle them, a decent respect to the opinions of mankind requires that they should declare the causes which impel them to the separation. We hold these truths to be self-evident, that all surgical educators have the obligation to instill in their students Knowledge, Mental and Physical Stamina and the pursuit of total patient care — That to secure these elements of surgical education, Departments of Surgery are instituted among Men, deriving their just powers from the basic principles of patient care, — That whenever any Form of Education becomes destructive of these ends, it is the obligation of surgical educators to alter or to abolish it, and to institute new forms of education, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Education. Prudence, indeed, will dictate that long established prinn should not be changed for light ciples of surgical education and transient causes; and accordingly all experience hath shewn that mankind are more disposed to suffer, while evils are sufferable than to right themselves by abolishing the forms to which they are accustomed. But when a long train off regulatoryy abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such bureaucratic and compliance constraints, and to provide new Guards for their future security. — Such has been the patient sufferance of current surgical education; and such is now the necessity which constrains them to alter their current Systems of Education. The history of the present constraints on surgical educan is a history of repeated injuries and usurpations, all havtion ing in direct object the establishment of an inferior form of surgical education. To prove this, let Facts be submitted to a candid world. Governing bodies off medical education n have refused to recognize principles of surgical education n that are most wholesome and necessary for the public good. Governing bodies of medical education n have forbidden the formulation of educational principles of pressing importance, When classical principles of surgical education have been suspended, those governing bodies have utterly neglected to attend to their consequences. Governing bodies of medical education n have refused to pass other Laws for the accommodation of large districts of dedicated surgical students, Governing bodies of medical education have called together conferences and meetings g at places unusual, uncomfortable, and distant from the mainstream of Ameriy for the sole purpose of fatiguing them into comcan surgery, pliance with their measures. Governing bodies of medical education have repeatedly failed to listen to the hue and cry from classically trained

s for opposing with manly firmness their invasions surgeons, on the principles of classical surgical education. n have refused for Governing bodies of medical education a long time, after such dissolutions, to cause others to be elected, whereby those classic principles, may be returned to the surgeons at large for their exercise; causingg dangers of invasion of poorly-thought-out programs and measures from without, and causingg convulsions within. Governing bodies of medical education n have endeavoured to prevent the population of this profession with dedicated students; for that purpose obstructing the interest in surgery and refusing to pass others to encourage their migrations into this profession. n have obstructed Governing bodies of medical education the orderly flow of patient care. Governing bodies of medical education have made surgeons dependent on his Will off the compliance officerr for the tenure of their offices, and the amount and payment of their salaries. Governing bodies of medical education have erected a multitude of New Offices, and sent hither swarms of Officers to harass our people and eat out their substance. Governing bodies of medical education n have kept among us, in times of peace, Standing Armies of compliance officers without the Consent of most surgeons. n have affected to Governing bodies of medical education render the bureaucracyy independent of and superior to the will of the working surgeon. n have combined Governing bodies of medical education with others to subject us to a jurisdiction foreign to principles of safe patient care, and unacknowledged by our common sense; giving his Assent to their Acts of dubious educational benefit: For imposing poorly-thought-out work-hour restrictions; For protecting them, by a mock Trial from punishment for any breach of an arbitrary code of conduct; For cutting off our educational pre-eminence in all parts of the world; For imposing Taxes on us without our Consent; For depriving us in many cases, of the benefit of a rational discussion about educational policy; For transporting us to national meetings in inconvenient places; For, establishing therein an Arbitrary government, and enlarging its Boundaries so as to render it at once an example and fit instrument for introducing the same absolute rule to all surgeons; For taking away our Charters, abolishing our most valuable educational Laws and by altering fundamentally the Forms of our Classical Educational Institutions; For suspending our own Legislatures, and declaring themselves invested with power to legislate for us in all cases whatsoever. Governing bodies of medical education n have abdicated Government here, by declaring us out of the norm of their definition of education. n have plundered Governing bodies of medical education

our reservoir of surgical knowledge and experience and have impaired the future safety of the surgical patient. n are at this time Governing bodies of medical education transporting large Armies of compliance officers to compleat the works off educationall tyranny, already begun with circumstances of Cruelty & Perfidy scarcely paralleled in the most barbarous ages, and totally unworthy the Head of an educated profession. Governing bodies of medical education have constrained our fellow classically educated colleagues, n have excitGoverning bodies of medical education ed domestic insurrections amongst educators, and have endeavoured to bring on the inhabitants of our frontiers, the merciless bureaucratic burden n whose known rule of warfare, is burdensome regulation. In every stage of these Oppressions We have Petitioned for Redress in the most humble terms: Our repeated Petitions have been answered only by repeated injury. An organization or governing body, whose character is thus marked by every act which may define an educational Tyrant, is unfit to be the ruler of surgical education. Nor have We been wanting in attentions to our administrative brethren. We have warned them from time to time of attempts by their legislature to extend an unwarrantable jurisdiction over us. We have reminded them of the principles of competent surgical care. We have appealed to their native justice and magnanimity, and we have conjured them by the ties of our common kindred to disavow these usurpations, which would inevitably interrupt our connections and correspondence. They too have been deaf to the voice of justice and of consanguinity. We must, therefore, acquiesce in the necessity, which denounces our Separation, and hold them, as we hold the rest of mankind, Enemies in Educational Philosophy, in Peace Friends. We, therefore, the classically educated surgeons of the United States of America, appeal to the patients of America of our intentions, do, in the Name, and by Authority of the good patients of these Colonies, solemnly publish and declare, That these united Surgeons are, and of Right ought to engage in classical surgical education, that they are Absolved from all Allegiance to the current governing bodies of medical edun and that all educational connection between them and cation the governing bodies of medical education, is and ought to be totally dissolved; and that as Free and Independent Educators, they have full Power to instruct residents, design a curriculum, contract with insurers, establish certification, and to do all other Acts and Things which Independent educators may of right do. — And for the support of this Declaration, with a firm reliance on the protection of Divine Providence, we mutually pledge to each other our Lives, our Fortunes, our sacred Honor and the future care of our patients.

(With attribution and apology to Thomas Jefferson) Readers may send comments to SurgicalIndependence@gmail.com

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

Metabolic Therapy or Bariatric Surgery: What’s in a Name? B Y C HRISTINA F RANGOU

illing a surgical procedure as a metabolic therapy rather than as a weight loss surgery attracted patients who were markedly different from typical bariatric surgery candidates, a new study has shown. For the first time, men and women were almost equally represented in the metabolic surgery population, and the

patients in this group were older than those in most bariatric studies and had a higher prevalence of diabetes. These patients more accurately represent America’s severely obese population than those in most studies of bariatric surgery, the investigators said. The study was published online in the Annals of Surgery (doi: 10.1097/SLA.0b013e3182759656). “This has huge ramifications that will change several aspects of perioperative and postsurgical care, therefore defining

an entirely new field of practice,” said lead author Francesco Rubino, MD, a bariatric surgeon at the Catholic University of Rome, Italy. In 2007, Dr. Rubino moved to New York’s Weill Cornell Medical College where he started a Gastrointestinal (GI) Metabolic Surgery Program and Diabetes Surgery Center. The metabolic surgery

‘We have to remember that many obese patients don’t have diabetes or metabolic disease and are pursuing the surgery for weight loss. Using both terms is the most inclusive approach and will attract both types of patients.’ —Stacy Brethauer, MD

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program operated separately from the hospital’s well-established bariatric surgery department. The two departments offered the same procedures as the bariatric surgery department and used identical eligibility criteria for patients but had very different stated goals. Instead of focusing primarily on weight loss, the metabolic surgery program emphasized treatment of diabetes and other metabolic disorders. The program was not coded as a provider for bariatric surgery in the electronic referral system of the institution. To investigate the outcomes of the new program, researchers studied 100 consecutive patients who underwent surgery in the bariatric surgery department and the GI metabolic surgery program. Patients treated in the metabolic program were older by four years (45.8±13.4 vs. 41.8±11.7; P<0.05), had a lower body mass index (42.4±7.1 vs. 48.6±9.5 kg/m2; P<0.01) and were more likely to have diabetes (62% vs. 35%; P<0.01), hypertension (68% vs. 52%; P<0.05), dyslipidemia (48% vs. 31%; P<0.05) and cardiovascular disease (14% vs. 5%; P<0.05). Diabetes was more severe among metabolic surgery patients, measured by higher glycated hemoglobin levels and a greater percentage of insulin use. Men accounted for 42% of the metabolic surgery population compared with 26% of the bariatric cohort (P<0.05). There were no deaths in either group and perioperative complications occurred in approximately 2% of see METABOLIC THERAPY PAGE 11

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

TNF Blockers Fail To Aid Stoma Reversal in Patients With Crohn’s B Y C HRISTINA F RANGOU

or two decades, physicians have prescribed therapies that block tumor necrosis factor (TNF)-for patients with Crohn’s disease (CD). But it has never been clear whether anti-TNF treatment affects the chances of stoma closure. Now, a study from the Cleveland Clinic suggests that anti-TNF therapy does not facilitate restoration of intestinal continuity in patients undergoing stoma diversion for severe perianal CD. “The results of our study contradict the assumption that we can select a group of patients with Crohn’s disease who require a stoma and start antiTNF after the stoma is created, with the expectation that this will facilitate stoma closure. This is simply unrealistic in the context of the current use and indications for anti-TNF,” said lead author Luca Stocchi, MD, a colorectal surgeon at the Cleveland Clinic, in Ohio. The study, which was presented at the 2013 annual meeting of the American Society of Colon and Rectal Surgeons, suggests the site of disease involvement, rather than anti-TNF therapy, strongly predicts the likelihood of stoma closure. Anti-TNF therapy was introduced in the 1990s for CD patients to help control symptoms of moderate to severe disease. The drugs have a proven record; about 80% of patients experience complete or partial responses to the TNF inhibitor (Dig Dis Sci 2013;58:797-806). However, studies analyzing TNF inhibitors and surgical outcomes are lacking. Few studies have examined the long-term outlook of patients who have a diverting stoma for perianal CD, and only one of these studies included patients who received anti-TNF treatment. The study by Dr. Stocchi and colleagues is the largest known study to evaluate the relationship between antiTNF use and closure of stomas. Dr. Stocchi and his colleagues conducted a retrospective review of all patients who had fecal diversion for complicated perianal disease at the Cleveland Clinic between 1994 and 2012. Of 162 patients in the study, 120 (72%) received TNF inhibitors. Patients who received biologics were slightly younger than those who did not (36 vs. 40 years). There were no other demographic differences between the groups. Analysis revealed no significant difference in rates of stoma closure between patients who used biologics and those who did not (28% vs. 24%, respectively; P=0.64). Proctectomy rates also were unchanged by biologic use (39% vs.

37%, respectively; P=0.79). Once perianal disease has progressed to the point of requirement of a stoma to control symptoms, surgeons are rarely successful in getting the disease to heal sufficiently to reverse the stoma, said Emily Finlayson, MD, MS, assistant professor of surgery, Institute of Health Policy Studies at the University of California, San Francisco. “The confirmation of this finding is important in that it will impact how we

counsel our patients. Many patients and doctors cling to the hope that treatment with anti-TNF agents will allow for future stoma reversal. We know now that this is unlikely.” The study showed that the site of disease strongly predicts rates of stoma closure. Patients with disease in the perianal region only had the greatest likelihood of closure, at 75%. The presence of perianal disease with small bowel disease was associated with a

45% closure rate, or three and a half times less likely to have stoma closure. Patients with perianal and colon disease were the least likely to have stoma closure with a 15% closure rate, and an odds ratio of 18.5. Ninety-one percent of patients who received biologic therapy started the treatment before their diversion was created. The timing of anti-TNF treatment had no effect on stoma closure, the study showed.

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GENIUS IN YOUR O.R. INSPIRED REVOLUTIONS IN SURGICAL GLOVE TECHNOLOGY. The surgeon wouldn’t admit he was nervous, exactly. But extra careful? Deﬁnitely. His own daughter was barely two years older than this patient undergoing a transplant. It was for moments like this that GAMMEX®, the world’s ﬁrst choice for surgical gloves, has come to America. Offering advanced solutions for nearly any procedure, GAMMEX® is a revolution in glove technology. Enjoy protection against allergic skin reactions, bacterial and viral contamination — and much more. Experience exceptional breathability, comfort, and lifelike tactility that’s as genuine as a teenage girl’s heart. For additional information or to request a sample, call Ansell today at (800) 952-9916 or visit us at www.ansellinfo.com/ggsn ® and ™ are trademarks owned by Ansell Limited or one of its affiliates. ©2013 Ansell Limited. All Rights Reserved. Story is provided solely for illustrative purposes and does not describe any actual surgeon, procedure or patient.

to this teenage girl.

In the News BOSTON

jcontinued from page 1 and it was time for a 26.2 mile party. Dr. Lepore ran alongside his daughter, thankful and excited to be part of what he likened to Christmas morning. “I’m 68,” said Dr. Lepore. “I was never fast, I’m not any faster now, but it’s such a fun event. The crowd does basically everything except use cattle prods to get you going.” Like every third Monday in April for the past 44 years, Dr. Lepore made his way east toward Boston proper, past Hopkinton, Ashland and Framingham; Quaint New England towns that might be described as, “sleepy,” 364 days of the year, but crackle with electricity on Marathon Monday. Everything was going according to plan as Dr. Lepore and his daughter coiled through Natick and Wellesley and turned onto Commonwealth Avenue at mile 18 when he received a call from his son. There had been an explosion. “Nobody else seemed to know it because things were going along smoothly,” Dr. Lepore said. “And then it became obvious something was going on because all the police vehicles took off.” By the time Dr. Lepore reached mile 19, just a mile and a half short of the infamous Heartbreak Hill, he and the remainder of the runners on the course were stopped. Their marathon was over. “Just like that, we were told, that’s it, we were done.” At that point, there was no way to know the extent of the terror that was happening just seven miles east. In Copley Square, screams and moans cut through an eerie silence. Everywhere, runners and spectators with mangled extremities, pulverized muscles, abdominal wounds, ripped blood vessels, shattered bones and soft flesh filled with nails and ball bearings were taken up, one by one, and rushed to local hospitals. Medical tent volunteers who anticipated a day of treating dehydration, muscle cramps and hypothermia applied tourniquets to control catastrophic hemorrhaging before shuttling victims to ambulances. Just a few hundred feet away from the finish line of the world’s most prestigious running event, there was more trauma and bloodshed than most medical professionals would see in a lifetime. As patients arrived in droves at Boston Medical Center, Beth Israel, Brigham and Women’s Hospital, and Massachusetts General, surgeons saw the same gruesome leg injuries again and again. The same decisions had to be made, with little time to ruminate: “Should we amputate on this one? What about this leg?” But after a week of terror following the bombing, with most Americans—runners and non-runners alike—glued to their televisions, a glimmer of good news emerged from the tragedy. Of the more than 180 victims with injuries who made

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

it to the hospital alive, all survived—a testimonial to fast care at the scene, on the way to hospitals, then in emergency and operating rooms (ORs). From an unprecedented horrific event in American history has emerged unprecedented success in the way that doctors, nurses and paramedics handled a surgical surge that is usually only seen on the battlefields in Iraq and Afghanistan. Dr. Lepore, who felt a very personal loss both as a runner and a surgeon, said, “The loss was tremendous, and there are many life-changing injuries, but it could have been a lot worse. The tremendous response showed what each of those hospitals could do, and they all rose to the occasion.” The surgical response preceding the bombings has given many examples of collaboration and efficiency that are useful to surgeons seeking to improve their practice.

Preparedness The ability to effectively organize in what had the potential to be a chaotic scene came down to disaster preparedness plans, according to George Velhamos, MD, chief of the Division of Trauma, Emergency Surgery and Surgical Critical Care at the Massachusetts General Hospital. “If we want to make a change in survival,” Dr. Velhamos said, “preparedness for the unexpected is absolutely necessary.” Preparedness for mass casualty events starts not with surgeons, but with the emergency medical teams and paramedics who are the first to aid and transport victims on the scene. One of the first directives that James Hooley, chief of Boston Emergency Medical Services (EMS), gave after the two bombs exploded near the finish line was for staff to alert hospitals of a potential mass casualty incident and to call for mutual aid. Eleven private ambulance services answered the call by immediately sending more than 40 ambulances to support Boston EMS to help transport the injured to local hospitals. According to the Boston Public Health Commission, within three minutes of the bombings, all Boston hospitals were notified of the mass casualty incident, and within five minutes mutual aid ambulance partners were asked to assist in the response. Boylston Street was cleared of patients in 18 minutes, and 90 patients from the scene were transported to area hospitals in approximately 30 minutes. Beyond the rapid response to the bombing, Dr. Velhamos noted that the initial triage in patients was what enabled surgeons to work in an orderly fashion as patients started to arrive. “In the short time that we arrived to the ER, within that time, patients were

An injured person is transported to Tufts Medical on April 15. Christopher Evans/Boston Herald

“We’ve practiced situations of mass casualty events, so when it happened, we knew what to do.” —George Velhamos, MD already arriving. The hospital providers did an outstanding job with triaging patients according to their level of injury.” In many mass casualty events, the walking wounded are usually the first to flood nearby centers, not leaving enough space and resources to those who arrive later and are in greater need of care. But Dr. Velhamos siad that this was not the case after the bombing because the Boston EMS System communicated so efficiently. As patients began to arrive at Mass General, Dr. Velhamos described the scene as, “orderly and not chaotic.” Many surgeons see mangled extremities on a regular basis, but very few deal with more than 20 at one time. But for the surgeons at Mass General and other

area hospitals, April 15, 2013 was merely a day in which years of preparation were finally put to use. “We’ve done disaster preparedness plans and simulation plans again and again, for many years,” said Dr. Velhamos. “We’ve practiced situations of mass casualty events, so when it happened, we knew what to do.” Many surgeons credit the contributions of the American College of Surgeon’s Committee on Trauma in the success in the surgical response following the bombings. COT’s mission is to develop and implement meaningful programs for trauma care in local, national and international arenas, and to provide professional development and standards

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

‘If two to three teams debate if a limb is salvageable, you thereby lose the ability to take care of two or three other patients over time. It’s the nature of mass casualty situations. You make your best call and you go with it.‘ —Carl Hauser, MD leg, for instance, it is standard protocol for a second surgeon to assent to the decision to amputate, but in situations of mass casualty, a second opinion is not always an option. “Management by committee in these circumstances leads to excess morbidity in the group as a whole,” said Dr. Hauser. “If two to three teams debate if a limb is salvageable, you thereby lose the ability to take care of two or three other patients over time. It’s the nature of mass casualty situations. You make your best call and you go with it.”

Damage Control Surgery Heightened security at Tufts Medical Center. Greta Rybus/Getty Images for CNN

of care. “Without the COT,” Dr. Vehamos said, “we wouldn’t have trauma systems, we wouldn’t have trauma teams, centers, standard of codes of managing trauma patients, no policies or protocols. It is this exact system put together that allows us to practice at the level that we do.”

Fast-Acting Leadership Although disaster preparedness plans are instrumental in creating the infrastructure necessary in dealing with mass casualty, Carl Hauser, MD, a surgeon in the Division of Trauma and Surgical Critical Care at Beth Israel Deaconess Medical Center explained it is up to individual hospitals to make those provisions work. “In the fog of war,” said Dr. Hauser, “one size does not fit all; you have to adapt locally.” For the team at Beth Israel, adaptation meant designating

local personnel with a strong knowledge of the hospitals’ resources as leaders. As one team examined patients as they were brought through the door, another team directed them to a specific OR, while another assigned a surgeon to individual victims in critical condition. “You need to be able to rely on the education of local personnel who will be able to adapt and know the hospital well enough to work out the logistics of where these people will go,” said Dr. Hauser. “It’s a secondary layer of triage.” Beyond figuring out logistics, it is crucial to rely on the most experienced staff to make the right call in individual cases, especially when it is not a matter of saving one limb, but of saving as many limbs as possible within a group, and there isn’t time for deliberation. In the case of deciding to amputate a

Beyond the outstanding preparedness and fast-acting adaptation that all of the Boston area hospitals exemplified in the hours and days following the bombings was the implementation of damage control surgery—the single most important breakthrough in trauma care in the past 20 years. The accumulated knowledge of treating blast injuries gained over a decade of war in Iraq and Afghanistan has lent an unexpected value to saving civilian lives in Boston. According to a 2011 study in the British Journal of Surgery, traumatized lower limbs has become the signature injury in the conflict in Afghanistan, and with an increase in lower leg injuries has come greater innovation in treating them. The multitude of lower leg injuries that victims in Boston suffered was an alltoo-familiar sight for surgeons who had served in the military. The principal of damage control surgery is to do just enough to stop hemorrhaging, control contamination and reduce fractures with the understanding that further surgeries will be performed when the patient is more stable. If a patient in critical condition is under anesthesia for too long, it often can do more harm than good. “It’s critical not to get too hung up on injuries that don’t affect life or functionality,” said Dr. Hauser. The idea is to do the least possible to keep the patient alive with reasonable function, and recognize that on day 2 or 3 that there will be more resources and more logistic capability. As Dr. Hauser noted, “there’s no use in clogging up the OR with doing things perfectly.”

Boston Medical Center personnel wait for victims from the marathon bombings to arrive. Jim Davis/ Globe Staff

When dealing with lower leg trauma, the single most important measure in damage control resuscitation is the implement of tourniquets in the pre-hospital environment. A 2012 study published in The Journal of Bone & Joint Surgery, reported that the most common cause of death from injuries in both Iraq and Afghanistan was bleeding out. Dr. Velmahos said, “It is an extremely simple yet underused tactic. Surgeons should work with their local EMS to ensure that tourniquets are provided in each ambulance.” After a patient arrives on the scene, the next step is rapid amputation and ongoing, through cleaning of the wound, including removal of dead, damaged or infected tissue. It is a process that requires coordination between vascular surgeons who repair torn blood vessels, orthopedic surgeons who stabilizes the bone and plastic surgeons who clean the wound. Determining functionality of the limb is paramount, as there is a very real risk for a patient dying while surgeons try to salvage nonfunctioning tissue. In other words, there is a big distinction between saving a leg and saving the function of a leg. “The worse thing is to put vessels, bone and muscle together, and still have a leg that cannot move. It becomes more of a burden to the patient, and they might fare much better with a prosthesis,” said Dr. Velhamos. In treating the blast victims, nearly all of the amputations performed were guillotine amputations, in which bleeding and contamination is controlled, but a surgeon does a followup procedure to close the stump in the following days. As Dr. Hauser put it, “In times of mass casualty, things don’t have to look pretty on day 1.” Although for many patients the path to recovery will be long and arduous, with hospital visits, stiffness from torn muscles, scars from operations, and arthritic joints, Dr. Velhamos recalls the moment when patients woke up, having a memory of blood spilling out of their legs, and being told they would live. It was, bizarrely, a happy moment, and many have the stellar communication, efficiency and training of the staff of local Boston hospitals to thank. But for what was an extraordinary event in the lives of many victims and their families was just another day on the job for Dr. Velhamos. “Trauma knows no boundaries,” he said. “It cuts across race, age and social status. As trauma surgeons, we see it everyday. We have seen it all.”

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

Pilot Program To Mobilize Obese Patients Reduces Staff Injuries, Costs Annual Savings Estimated at $233,125 Or More B Y C HRISTINA F RANGOU

unique pilot program designed to improve in-hospital mobilization of patients led to a 43% decrease in hospital-acquired pressure ulcers and a 38.5% drop in injuries among hospital staff. “It’s really been a remarkable

improvement in quality through a reduction in adverse events for both patients and employees,” said lead author Walter J. Pories, MD, an attending surgeon at Vidant Medical Center in Greenville, N.C., where the program was created. The hospital created a specialized 24-person lift team with round-the-clock availability to transport and mobilize heavier and sicker patients. When the expense of hiring and running the lift team was taken into account,

the hospital reported an overall cost savings for the year, estimated to be at least $233,125 annually. The money saved was the result of reduced costs of care for pressure ulcers and the significant decline in employee injuries and associated costs. Dr. Pories presented the study at the 133rd Annual Meeting of the American Surgical Association. Greenville, located in the eastern part of the state, has a higher prevalence of severely obese patients, and poor and

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elderly patients, than most areas of the United States. This patient population often is difficult to mobilize and can pose risks to the hospital staff who are responsible for transport. Over the past decade, staff at Vidant Medical Center reported an increasing number of work-related injuries and musculoskeletal disorders, frequently resulting from the manual lifting of patients. Direct and indirect costs associated with employee injuries topped $5 million. “It became apparent that we were losing nurses due to injuries,” said Dr. Pories. The hospital tried several ways to prevent staff injuries, including hiring an on-site ergonomist and installing motorized ceiling lifts. Neither strategy led to a significant drop in injuries related to patient handling. In 2011, the hospital came up with a novel pilot program to target employee injuries. They created a 24-member “lift team” consisting of people from various fields who were then trained in safe moving and lifting techniques. Lift-team members came from widely varied backgrounds such as personal training and emergency management. The teams worked in roving pairs, assisting the nursing staff with safe turning, mobilization, bed surface and moisture management compliance for patients who weighed more than 200 pounds, had a Braden score of less than or equal to 18 and/or pressure ulcers. Unlike previously reported studies of lift teams, Vidant Medical Center’s lift team provided 24-hour and weekend coverage. The program was implemented in six pilot units, including cardiovascular intensive care, cardiac intermediate care, medical intensive care, medical intermediate care, surgical intensive care and surgical intermediate care. Program administrators selected the units because of their high incidence of patient-handling injuries among employees and/or hospitalacquired pressure ulcers. In the first year of the program, outcomes improved for both staff and patients. Patient-handling injuries among employees dropped 38.5% from the prior year. At least two of the eight injuries reported would have been avoided had the lift team been involved in the transport of those patients, said researchers. In both cases, clinical staff did not contact the team to help move these patients. One member of the lift team developed a rotator cuff injury over the study period but it was unclear if the injury resulted from her job. Over the same period, patients developed fewer hospital-acquired pressure ulcers, the incidence of which fell by 43%, from 61 in 2011 to 35 in 2012.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

‘The cost of fixing one decubitus ulcer would be in the range of $20,000 to $30,000. If this type of approach can prevent a few decubitus ulcers from developing, then it makes sense that these programs could be cost-effective.’ —Philip Schauer, MD Staff at the hospital reported high rates of satisfaction with the program. In surveys conducted at the one-, six- and 12-month periods, 92%, 95% and 89% of respondents, respectively, said the lift team had a positive effect on their job satisfaction. Philip Schauer, MD, director of the Bariatric and Metabolic Institute at Cleveland Clinic, Ohio, said lift teams like the one at Vidant Medical Center could provide “tremendous benefit” to patients and hospital staff and reduce health care costs at the same time. “The cost of fixing one decubitus ulcer would be in the range of $20,000 to $30,000. If this type of approach can prevent a few decubitus ulcers from developing, then it makes sense that these programs could be cost-effective,” he said. Dr. Schauer also said that the project needs more testing, and additional information on things like lift-team training and financial implications is required before more institutions adopt similar programs. “This study finally calls attention to a very important, rarely discussed and often ignored problem: the challenge of mobilizing severely obese patients.” According to the fiscal analysis performed by the investigators, the lift team cost about $1.3 million in 2012 and resulted in reduced costs of more than $1.5 million when employee injuries and cost of pressure ulcers were taken into account. Investigators said that their calculations were conservative. The study also showed a high turnover rate among lift-team members. In one year, eight team members left their jobs, representing a 24% turnover rate. Half were terminated due to substandard performance and half resigned for personal or academic reasons. In an interview, Dr. Pories said turnover stabilized in 2013. He and his colleagues plan to do followup studies that will address the financial effects of the program and the causes of hospital-acquired pressure ulcers. The program remains in effect in the hospital. “We would now like to cover all units,” Dr. Pories said.

METABOLIC THERAPY jContinued from page 10

patients in each group. The study showed that the term “bariatric surgery” significantly influenced the selection of surgical candidates, the investigators said. Among traditional bariatric surgery patients, young women were overrepresented and diabetes was less prevalent than expected for a severely obese population, said Dr. Rubino. “That’s a result, perhaps, of the fact that the name and focus on weight loss results is more attractive to relatively

healthy young females than older men.” Based on their findings, Dr. Rubino and his colleagues are proposing the creation of a new surgical specialty called GI metabolic surgery—a GI operation with the primary intent to treat diabetes and metabolic disease. The term bariatric surgeryy would be reserved for patients who require surgery to address physical complications of excess weight but have no metabolic disease, said Dr. Rubino. Stacy Brethauer, MD, a bariatric surgeon and researcher at Cleveland Clinic in Ohio, said many programs have adopted both terms: bariatricc and

metabolic surgery. “Over time, some programs may remove ‘bariatric’ from their title. We have to remember that many obese patients don’t have diabetes or metabolic disease and are pursuing the surgery for weight loss. Using both terms is the most inclusive approach and will attract both types of patients,” he said. Dr. Brethauer added that bariatric and metabolic surgeons need to do more to emphasize the metabolic effects of the operations. Currently, less than 2% of eligible patients in the United States have access to bariatric and metabolic surgery.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

‘Watchful Waiting’ for Inguinal Hernia Safe, But Surgery Ultimately Likely

B Y C HRISTINA F RANGOU

ne of the ongoing debates in general surgery is whether to operate on men with asymptomatic or minimally symptomatic groin hernia, or wait. A recent study—and one of the largest—of American men with these types of hernia demonstrated that waiting may be safe, but most patients will end up needing a repair within a decade, usually because of worsening pain. The older a man is, the more likely he is to undergo a hernia repair. “Patients who present to their physicians to have the hernia evaluated, especially if they are elderly, should be informed that they will almost certainly come to surgery eventually,” said lead author Robert J. Fitzgibbons, MD, professor of surgery and chief of general surgery, Creighton University School of Medicine in Omaha, Neb. He presented the findings at the 133rd Annual Meeting of the American Surgical Association. The results of the study come from an updated analysis of one of the landmark, randomized trials in American hernia surgery. Between 1999 and 2004, Dr. Fitzgibbons and his colleagues from five North American centers randomized 720 men with minimally symptomatic inguinal hernias to a regimen of “watchful waiting” or standard tensionfree open repair. In 2006, they reported that watchful waiting was an acceptable option ((JAMA 295:285-292). One-fourth of patients who were being watched ended up needing surgery within the first two years of follow-up but surgical repair could be safely delayed until symptoms increased, the authors said. However, questions remained about what happened to patients after the first two years of watchful waiting. Dr. Fitzgibbons and his colleagues continued to track 254 men originally assigned to watchful waiting. Patients were contacted annually by mailed questionnaire, with follow-up phone and email requests to nonresponders. Using a Kaplan–Meier estimator, investigators calculated that 68% of patients crossed over to surgery within 10 years. Nearly all patients who decided to undergo repair did so because of worsening pain, said investigators. Only 2.4% of patients (n=3) required an emergency operation. Older men underwent surgery more

often than younger patients. The estimated crossover rate to surgery 10 years after diagnosis was 79.35% in men older than age 65 years, and 62% in men younger than age 65. The results confirmed those of another major randomized study, led by Patrick O’Dwyer, MD, professor of gastrointestinal surgery, Glasgow University in Scotland. In 2011, Dr. O’Dwyer and his colleagues reported that 72% of patients who are being “watched” undergo surgery

within 7.5 years (Br J Surgg 2011;98:596599). Moreover, men who underwent surgery reported improvements in their quality of life, whereas men in the watchful waiting group had declining qualityof-life scores. Dr. O’Dwyer and his colleagues concluded that medically fit patients with minimal symptoms should be recommended for surgical repair. “The findings from both studies are almost identical. We now recommend

repair for medically fit patients with asymptomatic inguinal hernia,” said Dr. O’Dwyer in an email interview. Guy R. Voeller, MD, FACS, professor of surgery, University of Tennessee Health Sciences Center, in Memphis, said surgeons in the United States have shifted away from the watchful waiting approach in recent years, particularly after Dr. O’Dwyer’s study was published. This latest study confirms an already widespread practice, he said.

Less pain. Less opioids. OFIRMEV® provides significant fi pain relief1

OFIRMEV re educes opioid consu umption1

Mean pain relief scores after initial dose1

Reduction in morphine consumption1

(Total hip or knee replacement surgery)

(Total hip or knee replacement surgery) 60

1.8 .8

OFIRMEV 1 g (q6h) + PCA morphine (n=49) Placebo Place l b + PCA morphine h (n=52) ( )

P P<0.05 1.2

OFIRMEV 1 g (q6h) + PCA morphine p (n=49) Placebo

–33%

+ PCA morphine (n=52)

Significant improvement over placebo + PCA morphine

Morphine (mg)

Worsening Pain Often Leads to Repair Anyway, Especially in Older Men

Pain relief

0.6

40 30

–46%

20 10

17.8 mg .0

9.7 mg

57.4 mg

38.3 mg

0 0 .25.50.75 1

Time (h) Sinattra et al (Pain Study 1) Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g (q6h) + 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. PP<0.05 at every time point.

Over 6 h P<0 <0.01 01

Over 24 h P<0 <0.01 01

Sinatra et al (Pain Study 1) Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g (q6h) + 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.

• The clinical benefit of reduced opioid consumption was not demonstrated

Indication OFIRMEV is indicated for the management of mild to moderate 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. Reference: 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.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

“Mostly, when patients are sent to a surgeon, they already have symptoms that justify a repair. When you do see the rare asymptomatic person, most of us say, ‘you don’t have to get it fixed now but I will be seeing you in the future.’” Dr. Voeller added that surgeons and primary care doctors should take note of a patient’s age when considering watchful waiting versus repair. “If you have a patient who is a little bit older, and in five years you’re looking at their heart or their lungs being worse, you may want to say that now is

‘If you have a patient who is a little bit older, and in five years you’re looking at their heart or their lungs being worse, you may want to say that now is the time to get it fixed.’ —Guy R. Voeller, MD

From the start. Administer OFIRMEV pre-op, then sched dule q6h CONTINUE WITH OFIRMEV IF:

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the time to get it [the hernia] fixed.” Dr. Fitzgibbons cautioned that the study focused on minimally symptomatic or asymptomatic patients who had already been referred to surgeons because of concerns about their hernia. As such, the results do not apply to the general population of patients with asymptomatic or minimally symptomatic inguinal hernias. “The take-home message is that patients who choose to see their doctor because of concerns about their hernia will almost inevitably come to surgery,” he said.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

Weight Loss Reduces Risk for Colorectal Cancer Diagnosis, Mortality B Y C HRISTINA F RANGOU SAN FRANCISCO—Individuals can lower their risk for colorectal cancer (CRC)— particularly cancers of the colon and especially among men—by increasing recreational physical activity, according to new research. Doing so will also significantly reduce the risk for death in patients who have been diagnosed with the disease.

Excess body weight also negatively affects diagnosis and prognosis. Obese individuals are more likely to be diagnosed with, and more likely to die of, CRC. Moreover, the effect of obesity is independent of treatment complications, meaning that obesity does not appear to negatively affect treatment, but does cause disruptions at a systemic level that treatment cannot overcome. “Counseling patients to achieve a normal body weight or a more healthy body

weight is probably indicated,” said Peter T. Campbell, PhD, a cancer epidemiologist and director of the tumor repository at the American Cancer Society, adding that patients should never lose more than two pounds per week and weight loss in cancer survivors should be achieved through exercise and proper diet. In his presentation of the research at the 2013 Gastrointestinal Cancers Symposium, Dr. Campbell said that the takehome message is that people can mitigate

their risk for CRC by losing weight and engaging in physical activity even while undergoing treatment. In 2010, a large meta-analysis demonstrated that every five-unit increase in body mass index (BMI) is associated with an 18% rise in risk for CRC (Obes Rev 2010;11:19-30). In other words, an individual with an obese BMI [≥30] has about a 40% higher risk for CRC compared with a person with a BMI in the lower range of normal [18.5-25], Dr. Campbell said, adding that the studies leave no question that “obesity is convincingly associated with colorectal cancer incidence.” However, the relationship between weight and CRC is not entirely straightforward. Results from the same study show that the association is stronger in men than in women and stronger for cancers that occur in the colon rather than the rectum. Furthermore, a high BMI appears to correlate only with a higher risk for tumors that display the more common microsatellite-stable phenotype, Dr. Campbell said. In a study of 1,794 case participants and 2,684 unaffected sex-matched siblings, each increase in BMI, modeled in 5 kg/m2 increments, was associated with an increased risk for microsatellite-stable tumors (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.24-1.54) and microsatellite instability (MSI)-low tumors (OR, 1.33; 95% CI, 1.04-1.72). No relationship was found for MSI-high tumors (OR, 1.05; 95% CI, 0.84-1.31), according to the study published by Dr. Campbell and his colleagues in 2010 in the Journal of the National Cancer Institute (102:391-400). More recently, the same research team confirmed that BMI is not only linked to risk for CRC but also to prognosis. In the Cancer Prevention Study II Nutrition Cohort—an ongoing, prospective study that includes regularly updated lifestyle and outcome data from more than 2,200 CRC survivors—patients who reported having an obese BMI several years before their cancer diagnosis had a higher risk for death (approximately 30%) from all causes, over the study period. They also had a 35% increased risk for death from CRC and a 68% increased risk for death from cardiovascular disease ((J Clin Oncol 2012;301:42-52). The study also showed that an individual’s BMI after diagnosis of cancer had no bearing on their long-term mortality risk, possibly due to the effects of both the disease and its treatment on a person’s weight. These findings were reinforced in January with the publication of a study that examined the effects of BMI in more than 25,000 patients with stage II and III colon carcinoma with the Adjuvant Colon Cancer Endpoints (ACCENT) database.

In the News

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‘The take-home message

is that people can mitigate their risk for CRC by losing weight and engaging in physical activity, even while undergoing treatment.’ —Peter T. Campbell, PhD Obesity—as well as underweight status— was independently associated with inferior outcomes in patients with colon cancer who received treatment in adjuvant chemotherapy trials (Cancer 2013 Jan 10. [Epub ahead of print]). Dr. Campbell said several factors could explain the relationship between obesity and poorer survival rates, including fatty acid synthase expressed in colon tumor tissue and the systemic effects of obesity. He noted that treatment did not appear to play a role. “We think, based on the evidence from our clinical colleagues, that it is not related to suboptimal treatment or surgery-related complications.” Physical activity levels also play a major role in CRC development. Many studies in the United States have consistently found that adults with higher levels of physical activity—in intensity, duration or frequency—can reduce their risk for developing colon cancer by 30% to 40% relative to those who are sedentary, regardless of BMI. A meta-analysis published in 2009 examined 14 prospective studies and found that the most physically active men experienced a 20% reduction in the incidence of colon cancer compared with those who were least active. In women, the effect was similar at about 14% (Colorectal Diss 2009;11:689-701). In a study published in the March edition of the Journal of Clinical Oncology, Dr. Campbell and his colleagues found that people who met the public health recommendation of at least 150 minutes of physical activity per week had a lower risk for all-cause and cardiovascular mortality. All 2,293 patients in the study were diagnosed with invasive, nonmetastatic CRC between 1993 and 2007. Analysis showed that those who completed at least 150 minutes of moderate-intensity activity per week had a 28% reduced risk for mortality compared with those who performed less than 60 minutes per week of moderate physical activity. Clinicians who treat cancer patients said they are emphasizing the importance of maintaining a healthy body weight and increasing physical activity to help patients manage their risk for recurrence. Frank Sinicrope, MD, professor of medicine and oncology at Mayo Clinic, Rochester, Minn., and the lead author of many studies looking at cancer and

obesity, said he counsels patients with a BMI of 30 kg/m2 or higher to consume nutrient-rich foods such as fruits, vegetables and whole grains; to reduce their red meat consumption; and to increase physical activity. “Obesity appears to be a source of chronic inflammation that can adversely affect multiple organ systems and, as such, contributes to cardiovascular disease and cancer, among others,” he said. James C. Cusack Jr., MD, associate professor of surgery at Harvard Medical School, Boston, said he and his colleagues are increasingly working with

their patients to help them achieve and maintain a healthy weight before and after surgery. He said that patients rarely have time to make significant changes in the period between diagnosis and surgery, but he does encourage them to participate in a programmatic weight loss and exercise program during neoadjuvant therapy to improve their surgical outcomes and their overall likelihood of surviving the disease. Surgeons also work more closely with patients to help them modify diet and lifestyle in the long term, he said. Recent data suggest that increased activity

levels and weight loss after surgery may improve the likelihood of surviving CRC, providing “a strong rationale for the surgeon to initiate the discussion of modifying diet and lifestyle for the longterm benefit of the patient.” Dr. Cusack and his colleagues are expanding their hospital’s weight loss program for preoperative bariatric surgery patients to include patients recently diagnosed with colon or rectal cancer. Cancer patients should not lose more than two pounds per week and any weight loss should be achieved through exercise and proper diet.

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‘The other woman was lying in bed looking like she had died and my patient was sitting with her legs crossed Indian style. All [that] the lady with the open gallbladder said was “once my surgeon gets in here, he’s dead.”’

LAP CHOLE

jcontinued from page 1 impressive achievement that he recalls with matter-of-fact modesty. “I didn’t think it was such a big deal,” Dr. McKernan told General Surgery News in a phone interview. “You’re just taking modern technology and doing the same operation. The reason I remember the date is it’s my son’s birthday.” In the 1970s, Dr. McKernan became adept at using scopes during a year of urology training and then surgical residency at Carraway Methodist Medical Center in Birmingham, Ala. After residency, Dr. McKernan had a choice: He could go work in research and development at Walter Reed Army Medical Center in Washington, D.C., using his PhD in pharmacology to treat burn injuries sustained in Vietnam, or move to a small town in Alabama called Jasper and use his surgery training at the local medical center. “I chose the little town,” Dr. McKernan said. “There was nobody there, no urologist, no specialties; there was nothing. So I wound up doing what my partners didn’t want to do, which meant I did all cardiac pacemakers, all gynecological and vaginal work, all colonoscopies, and laparoscopy too.” Dr. McKernan worked at Walker County Medical Center from 1977 to 1983, and later moved to Marietta to work at Promina Kennestone Hospital, which had the seventh busiest emergency room in the United States. “We did it all,” he said. “I was the only general surgeon that had laparoscopy training, but of course I never used it because there were 20 gynecologists there.” In those days, however, gynecologists weren’t operating with laparoscopes; they were just diagnosing with them. “They’d look inside a patient, determine something was wrong and then make a big incision,” Dr. McKernan recalled. Promina Kennestone Hospital is where Dr. McKernan met William Saye, MD, a gynecologist with whom he performed the first laparoscopic cholecystectomy. The two became friends and would assist each other in the operating room. “If I had a problem at night, I’d call up Saye to help me operate on a spleen and I’d help him do a Cesarean section,” Dr. McKernan recalled. Dr. Saye became interested in operative laparoscopy, and the pair travelled to Nashville, Tenn., to learn from James Daniell, MD, an obstetrician/gynecologist who was teaching gynecologists how to take out ovaries with a laparoscope. “The second I saw that, I said, ‘We can take a gallbladder out with this,’” Dr. McKernan said. Dr. McKernan was counseling the

—J. Barry McKernan, MD, PhD

J. Barry McKernan, MD, the first surgeon in the United States to remove a gallbladder laparoscopically. minister’s wife about her options for her upcoming cholecystectomy. He described the standard open method, which would involve making a big incision under the ribs. He also told her about a new but untested procedure, which involved creating several small holes in the abdomen to remove a diseased gallbladder. She

wanted the minimally invasive procedure. Dr. McKernan sent her to another surgeon for a second opinion. The other surgeon told her that laparoscopic cholecystectomy was experimental and no one had ever done it in humans (at that point, success with the procedure in Germany and France was not widely known [see “The First Lap Chole in Europe: A ‘Criminal’ Is Vindicated,” June 2013, page 7]). The minister’s wife recounted the visit to Dr. McKernan, noting that the other surgeon had said, “there’s no way he can do this.” Dr. McKernan agreed that the surgeon might be right, and that if something did go wrong, he’d have to switch to the open

procedure. “Fairly, I’d say there’s a 10% chance we can do this procedure,” Dr. McKernan told her. Despite his caution, Dr. McKernan’s patient wanted the new procedure. Dr. Saye, however, would not participate until Dr. McKernan wrote the malpractice company to make sure that they would be covered. “I wrote them that I did laparoscopy and cholecystectomy; my patient wanted a laparoscopic cholecystectomy; and that I wanted to check to see if the procedure was covered. Some bureaucrat in St. Paul, Minn., read my letter and wrote me back saying the procedure would be covered,” he recalled, as though

Laparoscopic Cholecystectomy: McKernan’s Two-Handed Technique (selected steps) From: Laparoscopy and the General Surgeon. McKernan and Laws. 1991.

1. Trocar positions.

2. Cystic duct separated from surrounding tissue.

3. Ligation of the cystic duct remnant to the gallbladder.

4. Placement of Endoloop ligature at the cystic duct– common duct junction.

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still not quite believing his luck. And before he could perform the procedure, Dr. McKernan had to purchase the necessary instruments, because the Marietta Surgery Center did not have them. On June 22, five people gathered in the operating room: Drs. McKernan and Saye, a scrub nurse, a circulating nurse and an anesthesiologist. After administering general anesthesia to the patient, Dr. McKernan made the first incision, placing a tube that insufflated the abdomen with carbon dioxide. He made four additional tiny incisions through which he inserted the instruments, including a laparoscope fashioned with a camera that broadcast the operation on a monitor and provided Dr. McKernan with a good visual of the inside of the abdomen, and an Argon fiber laser to cut the gallbladder free from the liver. The gallbladder was swollen with large stones, so, in the end, Dr. McKernan had to pull it out through a small suprapubic incision. It took 45 minutes to get the gallbladder surgically free, and Dr. McKernan had

caught the entire procedure on videotape. When Dr. McKernan returned to the hospital the next morning to visit his patient, he was immediately struck by the difference between the minister’s wife and another patient who was sharing the hospital room, having undergone an open cholecystectomy the day before. “The other woman was lying in bed looking like she had died and my patient was sitting with her legs crossed Indian style,” Dr. McKernan said. “All [that] the lady with the open gallbladder said was ‘once my surgeon gets in here, he’s dead.’” Initially, another surgeon, Eddie Joe Reddick, MD, received credit for performing the first laparoscopic cholecystectomy in the United States. In 1988, Drs. McKernan, Reddick and Saye had met over drinks at a gynecology meeting in Augusta, Ga., where Dr. Reddick was conducting a seminar on laser hemorrhoidectomy. Dr. McKernan revealed that he had plans to remove a gallbladder laparoscopically, which sparked Dr.

5. Gallbladder dissected free from liver bed.

7. Gallbladder opened with “S” retractors placed within gallbladder to enhance stone removal.

Reddick to attempt the same. Dr. Reddick successfully completed his first laparoscopic cholecystectomy in September 1988, three months after Dr. McKernan had performed his first. Dr. Reddick did much to publicize his accomplishment. “Dr. Reddick was a flamboyant, entrepreneurial man,” recalled John Hunter, MD, Mackenzie Professor and Chairman of Surgery, Department of Surgery, Oregon Health & Science University, Portland. “He was not shy about telling people what he had done.” Dr. Reddick and his partner, Douglas O. Olsen, MD, FACS, a general surgeon practicing in Nashville, quickly published their results in Surgical Endoscopyy (1989;3:131-133), but more notably, they presented a videotape of the procedure at the annual meeting of the American College of Surgeons (ACS). “It was a crazy time,” said Michael Kavic, MD, professor of surgery at Northeastern Ohio Universities Colleges of Medicine in Rootstown, Ohio,

6. Gallbladder engorged with stones preventing removal through the periumbilical incision.

8. Clips and sutures inspected.

‘I was getting all the referrals for gallbladder operations, and [other surgeons] were saying, ‘you can’t do this, you’re taking our practice, and we don’t believe in this procedure.”’ —Edward Felix, MD and founding member of Journal of the Society of Laparoendoscopic Surgeons. “Drs. Reddick and Olsen had a booth at ACS in 1989 and had a videotape running on a closed loop. People wondered what it was all about.” Using video provided almost instant communication for surgeons, and had a much greater impact than publishing in a journal, Dr. Kavic said. “Everyone at the meeting could see what they had done. It was when I first saw the procedure.” Across the country, in California, general surgeon Edward Felix, MD, had been performing oncologic surgical procedures along with the occasional open cholecystectomy in his private practice. He recalls going home one night in 1988, and tuning the channel to CNN to see news of Dr. Reddick’s laparoscopic cholecystectomy. “I thought, ‘wow, look at what those guys did,’” recalled Dr. Felix, director of bariatric surgery, Clovis Hospital, Fresno, Calif. “Dr. Reddick got famous quickly. He was on TV almost within minutes of doing the procedure.” But it was Dr. Reddick’s dream to be involved in country music. In the mid1990s, he left surgery and became a country music producer for several years. Eventually, he returned to surgery. He went into private practice and kept a low profile, Dr. Hunter said.

A Procedure’s Rise in Popularity Drs. McKernan, Saye, Reddick and Olsen were the first to teach laparoscopic cholecystectomy. They designed weekend courses in animal labs, which involved training in both laparoscopy and lasers. Almost half the time was spent on laser safety and teaching surgeons how to use the KTP or YAG lasers. “In the beginning, we didn’t call these [operations] laparoscopic cholecystectomies; we called them laser cholecystectomies,” said Robert Sewell, MD, a general surgeon at the Master Center for Minimally Invasive Surgery in Southlake, Texas, and an early pioneer of the technique. “There was a fear that using electrocautery put patients at a high risk of injury.” Dr. Sewell added, “Physicians would leave training courses and have to see LAP CHOLE page 18

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jcontinued from page 17 convince their hospital that they needed to spend $150,000 on new lasers. Some hospitals bought multiple lasers.” During procedures, there was a laser safety officer as well as circulating and scrub nurses. “Everyone was wearing these big laser goggles and the lights were turned down low so the room had a surreal glow to it,” Dr. Sewell said. “The whole room erupted in applause during those first few weeks of courses.” Using lasers, however, meant that operations were slow. The lasers were not very effective at cutting tissue. Frederick Greene, MD, remembers seeing a billboard in Atlanta that read, “Come get your laser laparoscopic cholecystectomy.” “Soon, though, it became obvious that if you used caution and CO2 insufflation, you could use electrocautery and lasers were phased out,” said Dr. Greene, former chairman of the Department of Surgery at Carolinas Medical Center in Charlotte, N.C. Dr. Sewell also noted that “within a couple of years, those lasers became nothing more than big paperweights in the operating room once we figured out it was safe to use electrocautery.” Many surgeons who took classes went home to set up their own training courses. Dr. Sewell was introduced to the technique after watching his first partner, Robert Waddell, MD, perform a laparoscopic cholecystectomy in December 1989. “Dr. Waddell jumped into this procedure silently,” Dr. Sewell recalled. “He went to one of Dr. Reddick’s courses in Nashville, came home to Fort Worth, Texas, and began collaborating with gynecologists at the hospital. As soon as I saw this, I thought, ‘well, this changes everything. I’ve got to do this!’” Although Dr. Sewell had no training at the time, Dr. Waddell proctored his first few procedures. Their hospital requested that surgeons receive some kind of formal training, so Drs. Sewell and Waddell set up a course. “Dr. Waddell had done maybe six to 10 laparoscopic cholecystectomies at that point and I had done two or three.” Dr. Hunter learned the technique in 1989, from George Berci, MD, senior director of Minimally Invasive Endoscopic Research at Cedars-Sinai Medical Center, in Los Angeles, and the two taught courses together every month starting in January 1990. “We made sure to have no more than 12 students per course so we could make sure each surgeon did three laparoscopic cholecystectomies, while other courses only provided surgeons with the opportunity to do one and sometimes to just watch.” When Dr. Felix saw surgeons were

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

starting to give courses on laparoscopic cholecystectomy, he was eager to learn as well. Once his wife had given birth, he ventured to the South to attend a class. “I went from doing virtually no gallbladders to 300 to 400 within the first year [of learning the new technique],” he said. “It was like a firestorm had hit. The procedure spread across the country in a year or two, and by 1991 to 1992, practically every surgeon in the country was doing a laparoscopic cholecystectomy.” During these early years, industry was instrumental in pushing the revolution forward. In 1989 and 1990, US Surgical and Ethicon, the two major equipment companies competing for supremacy in the laparoscopic market at the time, developed and sponsored training courses, approaching many of the pioneers to teach.

referrals for gallbladder operations, and [other surgeons] were saying, ‘you can’t do this, you’re taking our practice, and we don’t believe in this procedure.’” At the time, it was a radical idea that by eliminating a large incision you could improve a patient’s recovery. “But in truth, laparoscopic cholecystectomy was not anything new; it was the same operation done through a different access point,” Dr. Kavic said. Still, early on, the procedure was associated with a range of complications. Problems arose because many of the surgeons performing laparoscopic cholecystectomy were not well trained. Because training was only available through private weekend courses, a surgeon may have only performed the procedure once on a pig before attempting it on a patient.

‘We have spent the better part of two decades discussing the technology and techniques, but never a way to evaluate the expertise of a surgeon.’ —Robert Sewell, MD “We all got to know one another through industry,” Dr. Sewell said. “Companies like Ethicon and US Surgical became the driving force behind laparoscopic training.” It took about a year for enthusiasm for the procedure to ramp up, and by that time, the demand for learning laparoscopic cholecystectomy far outstripped the availability of training courses and instruments. “You could wait six months to get into a course. They were all booked solid,” said Dr. Sewell, adding that “for a while, surgeons were hard-pressed to find a set of laparoscopic instruments in the United States. I had to wait four to five months for the appropriate tools.” (See the next column for more on laparoscopic technologies.)

The Wild West Many surgeons who championed the technique experienced harsh criticism and resistance from those who deemed the procedure too radical and dangerous. The academic community wanted solid proof that laparoscopic cholecystectomy was better than open using double-blind randomized studies. But Dr. Felix noted, “It would have taken years to prove the efficacy of the technique, and the procedure would have become available in 50 years, not 10.” Dr. McKernan felt the resistance was not due to “fear of the unknown, but fear of losing the known. Suddenly, you’re not the expert anymore.” This viewpoint rang true for Dr. Felix, who experienced staunch resistance from his colleagues. “In 1990, general surgeons in Fresno were threatening me because I was taking their business,” Dr. Felix recalled. “I was getting all the

As a result, there were some initial problems and complications, Dr. Kavic said. Along the same lines, there was no credentialing available. “In a small hospital like ours, if surgeons had an excellent reputation, they could get privileges to do this new procedure as long as they were being supervised by someone with experience in laparoscopy,” Dr. Sewell said. “It was a bit sketchy, but surgeons argued that if you got into trouble, you could always convert to an open operation.” Dr. Berci agreed that it was important for surgeons to have proper and rigorous training and for institutions to have a system to evaluate how well they performed the procedure ((Am J Surgg 1990;159:273). Even today, Dr. Sewell believes that the issue of quality assurance in laparoscopic cholecystectomy should be better defined. “We have spent the better part of two decades discussing the technology and techniques, but never a way to evaluate the expertise of a surgeon.”

snowball effect. I’m very proud that I was one of the people who helped trigger this change.” In May 1990, SAGES issued guidelines in its journal, Surgical Endoscopy, on the clinical applications of laparoscopic cholecystectomy and also endorsed the procedure. By 1992, a National Institutes of Health (NIH) Consensus Statement recommended laparoscopic cholecystectomy as a legitimate tool to treat cholelithiasis (Surg Clin N Am 2008;88:1295-1313). In 1993, Dr. Greene, who was then the president of SAGES, started a series of courses, along with Jeffrey Ponsky, MD, from Cleveland, at Ethicon’s new training facility in Cincinnati to teach residents the technique. During this time, a series of studies emerged that found the technique to be more effective and safer than open cholecystectomy (Surg Laparosc Endosc 1991;1:2-7; Surg Endoscc 1992;6:169176), and many U.S. surgeons were invited to teach the procedure around the world. By 1995, 80% of gallbladders in the United States were being removed laparoscopically (Surg Clin N Am 2008;88:1295-1313). Reminiscing, Dr. McKernan recalled, “It was a fun time because for about six months, no matter what we did, it had never been done before.” It is also important to note that in those early days of laparoscopic cholecystectomy, there were probably 75 to 100 “cowboys” in the United States who openly blazed the trail, said Dr. Sewell, adding that “there were likely hundreds more who worked in more obscurity and never received any credit, but were equally important in perpetuating the transition of general surgery into the laparoscopic era.” Dr. Sewell believes the introduction of laparoscopic cholecystectomy changed general surgery. “Laparoscopic cholecystectomy represented a true paradigm shift,” he said. “It soon became clear that laparoscopy was the direction surgery was going.”

Growing Acceptance Although many academic units were initially reluctant to embrace laparoscopic cholecystectomy, and some were flatout against it, a few academic surgeons and institutions took a different stance. “The SAGES [Society of American Gastrointestinal and Endoscopic Surgeons] leadership immediately saw thee enormous potential of the procedure,”” said Dr. Hunter. Dr. Berci, emeritus clinical professorr of surgery at the University of California and the University of Southern California, Los Angeles, agreed. “We [att SAGES] developed a group of surgeons interested in leadership and this had a

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Every matrix has a story. Ours is based on outcomes. As demonstrated in peer-reviewed publications:

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Surgeons’ Lounge

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Coverage of the 24th Annual International Colorectal Disease Symposium All articles by Yaniv Cozacov, Clinical Fellow, Minimally Invasive and Bariatric Surgery, Cleveland Clinic Florida

The Watch-and-Wait Strategy Rodrigo Perez, MD, explained the concept of the watch-and-wait strategy in regard to rectal cancer patients undergoing chemoradiation therapy (CRT) reaching complete cancer remission (clinical or radiological, not pathologic).

Welcome to the July issue of The Surgeons’ Lounge. This month, we bring you the final part of our coverage of the 24th Annual Jagelman/34th Annual Turnbull International Colorectal Disease Symposium, hosted by Steven Wexner, MD, from Cleveland Clinic Florida in Weston. It is always our pleasure to bring you annual updates in the diagnosis and treatment of colorectal diseases from the leaders in this field. Sincerely, Samuel Szomstein, MD, FACS Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Radical surgery has always been the influence the rates of complete tumor absence of cancer cells also suggests CRT completion and also may reflect mainstay of treatment for rectal cancer regression. Another factor that may influthe possibility of lymph node steril- potential interruption of ongoing radiawith appropriate total mesorectal exci- ence tumor regression following neoadization as a result of CRT. tion-related tumor necrosis. sion. Additional therapy in the form of juvant therapy is the time lapse between • The overall number of recovered Dr. Perez explained that the strategy CRT in selected patients considered at completion of treatment and assessment nodes is significantly decreased in is to assess tumor response at least eight a higher risk for local disease relapse was of response. This was first suggested by patients after neoadjuvant therapy. weeks after CRT completion, includput in place. data from patients with anal cancer who This effect has also been shown to be ing clinical assessment with digital rectal Postoperative radiation (adjuvant) exhibited a significant increase in tumor time dependent because longer inter- examination, rigid proctoscopy and carcicame first and was found to improve local response simply by waiting eight weeks val periods between CRT comple- noembryonic antigen levels in combinadisease control, but at a considerably high after completion of therapy instead of tion and surgery were associated with tion with radiological assessment, mainly cost in terms of toxicity and long-term four weeks. This is where the relativefewer recovered nodes. performed to rule out residual extralumicomplications. Preoperative radiation ly new concept of the “watch-and-wait” In this setting, patients with apparent nal disease. Only patients fulfilling these (neoadjuvant) improves local disease con- strategy comes into play (Figure). Other complete clinical tumor regression would stringent criteria have been considered trol and significantly decreases immediate retrospective studies have indicated that be ideal candidates for alternative strate- for this nonoperative approach (watch and long-term toxicities. Chemotherapy, longer interval periods were associated gies, including not undergoing immediate and wait). Patients with any small residwhen added to the former mix, is benefi- with increased rates of complete tumor surgery and rigorous, close observation. ual nodule or excisable scar are managed cial in terms of local disease control. regression. But are patients being put at risk by by a full-thickness transanal excision priFurthermore, the benefits of neoadjuTherefore, the degree of tumor down- leaving microscopic residual disease with- marily as a diagnostic (or eventually as a vant chemoradiation were not restrict- staging is time dependent, suggesting that in the rectum or in perirectal nodes? Clin- therapeutic) approach. ed to long-term local disease control, but the longer the wait, the more successful ical assessment alone has been shown to In a retrospective analysis of patients could in actuality lead to variable degrees the tumor regression, and CRT seems have quite disappointing sensitivity and managed by this approach, patients with of tumor regression, by either prima- to exert significant effects in perirectal specificity rates in previous retrospective complete “clinical” response did no worse ry tumor reduction in size (downsizing) nodes in addition to the primary tumor, studies. However, some of these studies than patients managed by radical surgery or the reduction of the depth of penetra- as follows: included tumor response assessment per- and complete “pathological” response tion and possible perirectal node steriliza- • Tumors treated by neoadjuvant CRT formed at six weeks from CRT comple- in terms of survival. Late local relapses tion (downstaging). With these advances, have consistently shown decreased tion, possibly too early, and reflecting the occurred in approximately 10% of patients several reports have shown up to 42% rates of stage III or node-positive detection of residual disease in the setting of the watch-and-wait group, and at a complete pathologic tumor regression foldisease. of ongoing necrosis. Studies also have considerably longer interval when comlowing neoadjuvant treatment. • Rates of micrometastases among peri- detected residual microscopic nodal dis- pared with systemic relapses. AdditionHowever, there is the question of rectal nodes seem to be decreased by ease in patients with complete pathologic ally, patients with exclusive local relapse whether these complete pathologprimary tumor regression (ypT0). Again, were all amenable to salvage resection. neoadjuvant CRT. ic responses could be predicted without • The observation of residual mucinous these studies included patients managed In a retrospective review, there was no having radical surgery or if it is possible deposits among lymph nodes in the by radical surgery after six weeks from continued ON PAGE 22 to solely rely on clinical and radiological evaluations. On one hand, comBaseline pretreatment Tumor present at 6 weeks No tumor at 16 weeks plete tumor regression is assured with radical resection but on the other, it is exposing patients to a considerably morbid procedure, leading to variable rates of urinary, sexual and fecal dysfunctions. Also, the requirement for temporary or permanent stomas and the expected procedure-related mortality are substantial. Several other factors come into play considering the degree of tumor regression. Both radiation doses Figure. The watch-and-wait strategy in patients with distal rectal cancer and complete clinical response and chemotherapy regimens may

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survival compromise in patients with initial suspicion for complete “clinical” response who underwent delayed surgery for early tumor regrowth. The addition of chemotherapy cycles during the radiation therapy (RT) and the “resting” period between RT and surgery with a modest increase in RT dose (from 50.4 to 54 Gy) has led to a significant increase in complete clinical response rates to more than 50% of patients. Moreover, assessment of tumor response may further improve its accuracy with the combination of different radiological modalities such as positron emission tomography/ computed tomography and magnetic resonance imaging brought together in a single radiological study as well as using individualized intervals between CRT completion and the assessment of tumor response for different groups of patients. Treatment of rectal cancer has become increasingly complex and truly individualized. In this setting, a wide range of alternatives will probably offer optimal oncologic results with minimal unnecessary morbidity instead of a one-size-fits-all treatment strategy.

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Using Genetics for Personalized Treatment Of Colorectal Cancer Matthew Kalady, MD, from the Digestive Disease Institute at the Cleveland Clinic in Ohio, reported that individualized treatment decisions for colorectal cancer (CRC) based on genetic or molecular information are becoming more and more prevalent. Specific mutations, gene polymorphisms, chromosomal aberrations and even combinations of gene expression levels in the form of gene signatures have been reported as unique ways to characterize distinct subsets of patients with CRC. Dr. Kalady said that the paradigm has shifted from “If you’ve seen one colorectal cancer, you’ve seen them all” to “If you’ve seen one colorectal cancer, you’ve seen that one colorectal cancer.” According to Dr. Kalady, few genetic or molecular markers have been adopted into clinical practice in CRC. KRAS oncogene mutations and tumor microsatellite instability (MSI) have been found to have both prognostic and predictive value. MSI also is important in identifying patients and families with Lynch syndrome. Recently, mutation in the BRAF oncogene was found to be prognostic and predictive, although not yet routinely used in practice. Dr. Kalady also stated that

gene expression signatures were among the new emerging biomarker platforms.

patients who are unlikely to respond. Furthermore, he said that the National Comprehensive Cancer Network (NCCN) currently recommends determining KRAS gene status for patients with suspected or proven metastatic or synchronous colorectal adenocarcinoma, as this would help to target treatment.

KRAS S in Colorectal Cancer The KRAS S gene product is an important signal transducer in several signaling pathways and mutation in this gene could result in abnormal cell growth and proliferation. Dr. Kalady said that mutation of the KRAS S gene occurs in approximately 40% of CRCs, and that the most common sites of mutation are in codons 12 and 13 of exon 2. Several studies have noted a lack of response to CRC treatment due to KRAS mutation. Epidermal growth factor receptor (EGFR) inhibitors (cetuximab and panitumumab) are generally used after failure of first-line chemotherapy. Their effectiveness in this situation has been proven in randomized controlled trials. Dr. Kalady noted that KRAS S mutation is considered a predictive biomarker, helping to select

BRAFF in Colorectal Cancer The BRAF F gene encodes a downstream effector of KRAS S and is involved in the same pathway as described above. According to Dr. Kalady, approximately 15% of CRCs have a BRAF F mutation, yielding a poorer prognosis for the patient. BRAF F has not been used routinely as a biomarker in clinical practice. It has been recommended, however, by the NCCN to test for BRAF F mutation status in patients who are being considered for anti-EGFR therapy with a tumor that is KRAS S wildtype.

MSI in Colorectal Cancer Microsatellites are short tandem repeating DNA sequences, exist throughout the human genome and are prone to mistakes

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large cohort of a Phase III trial was analyzed for disease-free survival (DFS) according to MSI (Bertagnolli et al. J Clin Oncol 2009;27:1814-1821). Patients were randomized to receive adjuvant 5-FU with or without irinotecan. Study authors reported a nonstatistically significant trend toward improved DFS in MSI patients treated with irinotecan, suggesting that tumor MSI status may be predictive of response to irinotecan in stage III colon cancer. Conversely, Tejpar et al reported on another trial that randomized patients with stage II and III disease, and concluded that MSI-H was not

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The relationship between MSI status and response to chemotherapy has been controversial. Two early studies demonstrated no difference in outcome with 5-FU adjuvant therapy based on MSI status. However, the majority of evidence now supports MSI as a prognostic marker, Dr. Kalady said. (The seminal paper on this topic was published in 2003 by Ribic et al [N Engl J Medd 2003;349:247257] and then later another study was published by Sargent et al [[J Clin Oncol 2010;28:3219-3226]. A small retrospective study of stage III patients with colon cancer with MSI suggested that outcomes were improved with FOLFOX (leucovorin, 5-FU and oxaliplatin) therapy compared with 5-FU alone. Additionally, a

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Multiple studies have demonstrated MSI-H CRCs have a better prognosis than microsatellite-stable tumors. Because of the strong favorable prognostic value of MSI in colon cancer and the lack of benefit from fluorouracil (5-FU) adjuvant therapy, the NCCN recommends that CRC patients with stage II disease should be considered for MMR testing.

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MSI as Prognostic Marker

associated with any survival advantage when treated with irinotecan (Oncologist 2010;15:390-404). Based on the current data, Dr. Kalady said that no definitive conclusions could be drawn regarding the effect of oxaliplatin or irinotecan-based chemotherapy for patients with MSI-H CRC.

Dr. Kalady concluded his presentation by stating that, despite increasing knowledge about the genetics of CRC, few genetic tests have been validated and adopted into clinical practice. KRAS mutation analysis and MSI are now used in clinical care and are recommended by the NCCN guidelines. Genetic signatures are being introduced, but their value in prediction models is unsupported. Medicine will continue to move toward a more personalized approach, but well-designed, adequately powered studies are needed to evaluate true prognostic and predictive uses of different markers in the future.

. 352

MSI-H tumors are associated with distinct histologic characteristics such as tumor-infiltrating lymphocytes, mucin and Crohnâ&#x20AC;&#x2122;s-like reaction. Recognizing these features may trigger further examination of the tumor to determine MSI status, Dr. Kalady said. He suggested that identification of MSI in a CRC should arouse suspicion for Lynch syndrome and that this information should be viewed in the context of the patientâ&#x20AC;&#x2122;s age, location of tumor and family history. He further noted that the NCCN guidelines recommend that patients who are aged less than 50 years undergo MMR protein testing due to an increased likelihood of Lynch syndrome.

Several studies have noted a lack of response to CRC treatment due to KRAS mutation.

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in DNA replication secondary to misalignment of DNA synthesis factors, Dr. Kalady said. Specialized mismatch repair (MMR) proteins repair these DNA mismatches. However, loss of MMR function results in an accumulation of DNA transcription errors and a variable number of nucleotide repeats in the tumor relative to surrounding normal tissue. These tumors are known as microsatellite unstable, or microsatellite instability-high (MSI-H). Dr. Kalady reported that approximately 20% of all CRCs are MSI-H, and of these, about 80% arise through loss of the MMR function by silencing of the MLH1 gene by promoter methylation, whereas the remaining 20% arise due to hereditary loss of MMR function (as in Lynch syndrome).

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0OSTGRADUATE #OURSE #ONTROVERSIES IN #ANCER #ARE 3ATURDAY &EBRUARY 0- n 04HIS COURSE WILL ENTAIL A CASE BASED DISCUSSION OF HOT TOPICS AND CURRENT CONTROVERSIES IN THE MANAGEMENT OF VARIOUS CANCERS !TTENDEES WILL UNDERSTAND THE PRINCIPLES IN THE MANAGEMENT OF CARCINOID AND OTHER NONFUNCTIONAL NEUROENDOCRINE TUMORS OF THE GASTROINTESTINAL TRACT DISCUSS OPTIONS FOR MODERN MANAGEMENT OF COLORECTAL CANCER AND COLORECTAL HEPATIC METASTASES REVIEW SALIENT SCIENCE AND CLINICAL MANAGEMENT OF GASTROINTESTINAL STROMAL TUMORS OUTLINE THE SIGNIFICANCE AND MANAGE MENT OF INCIDENTAL PANCREATIC NEOPLASMS REVIEW THE BEST PRACTICE APPROACH TO GALLBLADDER CANCER DISCUSS CURRENT CONTROVERSIES IN BREAST CANCER AND UNDERSTAND CONTINUED CONTROVERSY OVER MANAGEMENT OF MELANOMA 4HE TOPICS WILL COVER 3O THE ENDOSCOPIC BIOPSY SHOWS ITS CARCINOIDxNOW WHAT #OLORECTAL CANCER AND SYNCHRONOUS HEPATIC METS OH MY 7HEN NEOADJUVANT THERAPY FOR COLORECTAL CANCER WORKS TOO WELL 7HAT S THE GIST WITH ')34 0ANCREATIC )NCIDENTALOMA 4HE 2ADIOLOGIST SAYS IT MIGHT BE A GALLBLADDER CANCER "REAST #ANCER 7HEN )S %NOUGH %NOUGH -ODERN -ELANOMA -ANAGEMENT

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Mental Conditioning in Surgical Education In his presentation, Raul Rosenthal, MD, department chair, Bariatric and Metabolic Institute at Cleveland Clinic Florida, Weston, discussed mental conditioning, or mental training in surgical education—a concept derived from the worlds of sports and aviation. The goal of mental training is to enhance performance and achieve maximal dexterity and preparedness during action time. This allows for speed response, meaning “simply being good when it counts” (Figure 1). Athletes execute complex muscle movements—which

involve several motion sequences— requiring high levels of deftness and cognitive function. Additionally, they must perform at the highest level with minimal time to react and cognitively process their responses under stressful conditions. For athletes, mental training Figure 1. The goal of mental training.

works by optimizing their movements and reducing cognitive interference. The way in which athletes undergo mental training is by systematically repeating a movement in their imagination, without actually performing it. The way a complex movement, or a series of motions, are mentally processed, is first to be broken down into the mainstay of nodal points (Figure 2). For example, if a soccer player is to kick a ball, he or she would first break down the sequence into selecting the target, selecting which foot to kick with, approaching the ball and then kicking it. In the same way, when applied to surgery, a procedure is to be described in detail, the nodal points extracted, and then the trainee can imagine each mental point separately until the whole procedure is mentally processed.

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It has been shown that pilots who regularly undergo a series of simulated training enhance their proficiency under stress and are able to master abnormal situations. In aviation, the nodal points exist in the form of a checklist. In normal and abnormal situations, the pilots are going through processes for takeoff and landing. It has been shown that pilots who regularly undergo a series of simulated training enhance their proficiency under stress and are able to master abnormal situations. This proficiency declines over time, so pilots need to train regularly to retain it. Aviation safety is measured by accidents per 1 million flights. The number of fatal accidents is more than three per 1 million when the aviation company does not appropriately select their pilots, does not have internal training for pilots, has no homogeneity of staff and does not conduct training on simulators. However, when

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using a functional MRI imaging study to record both actual and ideomotoric movements. Dr. Rosenthal summarized the following: â&#x20AC;˘ Additional mental training is effective. â&#x20AC;˘ Mental training can be learned easily by surgeons in two hours. â&#x20AC;˘ Cognitive rehearsal is cheaper than practical training. â&#x20AC;˘ Once a surgeon has the necessary skills, he or she can carry out mental training on his or her own. â&#x20AC;˘ Mental training can be transferred Figure 2. Complex movement is broken down into the mainstay of nodal points. all of these factors are implemented, the number of fatalities drops to 0.2 per million, an important distinction when one considers that approximately 10 million flights are made in the United States every year. So how can mental training be used in surgery? It can reduce the stress potentials by optimizing movement and operating room performance. Mental training is performed in four different training sessions: 1. External observation training: The trainee observes a role model performing the movement that the trainee wishes to learn. 2. Subvocal training: The trainee conjures up a clear visual image of the movement through external or internal self-talk. 3. Internal observation training: The trainee visualizes himself or herself, or another person from the outer perspective performing the movement he or she wants to practice. 4. Ideomotoric training: The trainee imagines the movement from the inner perspective, visualizing the execution of the movement and trying to feel as many sensory aspects of the process as possible. Ideomotoric training relies on the fact that, regardless of whether a person actually performs a muscular movement or imagines himself or herself doing so, the brain will register it the same. For example, if a person lies still and moves an index finger, under functional magnetic resonance imaging (MRI) the frontal cortex would enhance (the frontal cortex is responsible for planning of the movement) and the motor cortex in the region innervating the index finger also would enhance. In the same manner, if a person were to lie still but only imagine moving his or her index finger, the brain will enhance in the same pattern as if the finger was moving. This is the core of mental training, where complex movements in both cases are recorded by the brain and retained as muscle memory. Roth et al showed this

easily to other procedures. â&#x20AC;˘ Mental training cannot replace practical training. â&#x20AC;˘ Mental and practical training should be combined, as it occurs in sports, and should be viewed as a relevant and valuable part of surgical training.

khorty@mcmahonmed.com.

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Infertility After Ileal Pouch–Anal Anastomosis Tracy Hull, MD, from the Cleveland Clinic, in Ohio, presented the broad issues of infertility in female patients with ileal pouch–anal anastomosis (IPAA). Studying infertility after IPAA is quite challenging. The literature is mostly retrospective; definitions of infertility are not always clear; and patients are different ages before and after the IPAA, which also affects fertility. Sometimes patients have undiagnosed infertility issues even before undergoing an IPAA procedure. These questions are

important in order to advise patients, especially when contemplating whether to do an ileostomy and defer IPAA until the patient has completed her family. To investigate the effects of an IPAA procedure on fertility, researchers analyzed seven studies, which included 945 participants. They found that before the procedure, 12% of patients were infertile,

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whereas afterward the infertility rate was 26%. Patients with familial adenomatous polyposis (FAP) showed no difference in fertility when ileorectal anastomosis (IRA) was compared with IPAA. Gorgun et al found that only patients with intraoperative transfusions had difficulty conceiving after undergoing an IPAA procedure (P=0.023), P and the findings also showed that infertility rates were higher after surgery in patients between the ages of 30 and 39 years.

Among pregnant women who have had IPAA, pouch function may decrease during pregnancy, causing increased stool frequency and fecal incontinence, but should return to pre-pregnant function after delivery. Infertility may be caused by pelvic dissection leading to adhesions and tubal obstruction. Cornish et al found that tubal factors were responsible for an 80% infertility rate in IPAA patients compared with 30% in a control group. Among 21 patients who underwent a hysterosalpingography after IPAA, onethird were found with normal tubes, whereas 52% had a single tube occlusion and 48% were found with uterine tubes adherent to the pelvic floor. Hull et al compared laparoscopic surgery with open surgery in 40 patients and found significantly fewer incisional, abdominal and adnexal adhesions in the laparoscopic group. Furthermore, the adhesions in the laparoscopic group involved mainly the ports and extraction site. Similarly, Indar et al from Mayo Clinic reported that of 34 patients who underwent a laparoscopic IPAA procedure, 50% of patients had no adhesions at all and 71% had no adnexal adhesions. None of the patients in the group was found to have bilateral adnexal adhesions. Among pregnant women who have had IPAA, pouch function may decrease during pregnancy, causing increased stool frequency and fecal incontinence, but should return to pre-pregnant function after delivery. Therefore, the question of whether a vaginal or a cesarean delivery is the safer method is an important consideration. Hahnloser et al from Mayo Clinic monitored 232 pregnant women who underwent IPAA. Twentyseven percent of the subjects elected to have a cesarean delivery. The researchers found no significant differences in pouch complications or functional problems when they compared cesarean with vaginal delivery. Lepisto et al compared 160 patients, post IPAA, with a control group of 160 women post appendectomy. Nineteen of the IPAA patients underwent vaginal delivery and 21 had cesarean delivery. In the control group, 40 participants had a vaginal delivery and 13 had a cesarean delivery. The results showed that the

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control group had greater fecal incontinence than the IPAA group (P=0.064), and the authors concluded that recommending a cesarean delivery for patients with IPAA should be based only on obstetric indications. In a study of ulcerative colitis, Ravid et al mailed questionnaires to pregnant women with an IPAA to assess them for chronic ulcerative colitis. Of respondents, 29 patients had 49 deliveries (25 vaginal, 24 cesarean). There were two pouch-related complications during the pregnancies and four pouchrelated complications postpartum. All were treated nonsurgically. Stool frequency and day and night incontinence increased during pregnancy for most patients, but after delivery, pre-pregnancy function was restored in 83%. Five patients (17%) had some degree of permanent deterioration in pouch function. Of these, three had vaginal and two had cesarean deliveries. Multiple births and birth weight were not found to adversely affect subsequent pouch function. The researchers concluded that there was no difference in fecal incontinence or incontinence scores before and after pregnancy (vaginal vs. cesarean delivery). Remzi et al asked patients who had at least one live birth after IPAA to return for a comprehensive assessment. They were administered questionnaires as well as anal sphincter integrity (endosonography) and manometric pressure measurements. Anal sphincter physiology also was evaluated with electromyography, and pudendal nerve function was examined by nerve terminal motor latency technique. The researchers compared 20 vaginal deliveries with 60 cesarean deliveries and found significant differences in anterior sphincter defects: 50% for vaginal delivery patients and 13% for cesarean patients (P=0.012). There were no functional differences between groups at follow-up. The researchers concluded that recommendations for vaginal delivery should be made cautiously. In summary, there are no established recommendations due to the wide disparity in the literature. Vaginal delivery places all women at risk for a sphincter injury. Cesarean delivery rates remain high in IPAA patients, as long-term effects of occult sphincter injury or pudendal nerve injury associated with vaginal delivery are unknown. Vaginal delivery appears safe in the short term but it is unknown if any impairment in sphincter muscle integrity occurs in the long term, causing concern about effects on the anal musculature after vaginal delivery. Dr. Hull concluded that cesarean delivery among patients post IPAA probably would be a safer method than vaginal delivery.

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income and reveling in the technical performance of an operation, we have all made, and will continue to make, generous sacrifices of our time and personal comfort in the service of our patients. Many of us have shared the view that CMS surveys result in more particular and yet arbitrary citations than those generally issued by The Joint Commission (TJC)â&#x20AC;&#x201D;formerly the Joint Commission on Accreditation of Healthcare Organizations ( JCAHO)â&#x20AC;&#x201D;which has tended to take a self-improvement approach, establishing guidelines rather than specific approaches to satisfy established standards. This theme is expressed in TJCâ&#x20AC;&#x2122;s mission â&#x20AC;&#x153;to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.â&#x20AC;? Historically, JCAHO accreditation paved the way for CMS accreditation. Although our hospital received exemplary ratings from TJC approximately two years ago, subsequent CMS survey citations seemed contradictory to our favorable TJC rating. The CMS survey of our surgery center preceded that of the main hospital and led to citations for doublegloving during operations and for using any sort of extension cord even with hospital standard mobile plug towers. This led to the disappearance of all extension cords despite the fact that there were no substitute long cord options for frequently used operating room (OR) equipment. We wondered if we were required to move the OR table over to the wall outlet in order to use a lighted, rigid proctosigmoidoscope, one of the more ancient instruments in use and never associated, to my knowledge, with setting patients, drapes or staff on fire or

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

electrocuting anyone after more than 50 years of use! The double-gloving citation was unintelligible until the main hospital survey clarified that the under-glove could not be regarded as sterile once the outer glove was removed. Of course, anyone who has double-gloved for an operation and changed the outer glove when a hole developed in it knows that a major reason for double-gloving is the risk for single-glove failure.

instructed the circulator to pull out a few hairs that strayed d from my cap! On that occasion (and many others), loose straands have been gently tucked baack under the cap during a lon ng case by kinder OR stafff. Conversely, what holds th he bouffant in place on th he near-bald male surgeon? The question of wheth h-

We must find the character and conviction to creatively eatively reinvigorate the culture of surgery, our guild, andd find meaningful connections with the other professionals onals whose scope of work overlaps our own. Regarding the surgeonâ&#x20AC;&#x2122;s cap, deeper investigation into the recommendations by the Association of Operating Room Nurses (AORN) on head coverings in the OR (that formed the basis of the CMS directive), revealed no convincing evidence that hair or scalp exposure in the OR constitutes an infection risk for patients (2010 Perioperative Standards and Recommended Practices. Aseptic Practice. Recommended Practices for Surgical Attire, Recommendation II: â&#x20AC;&#x153;Personnel should cover head and facial hair, including sideburns and necklines, when in the semi-restricted and restricted areas of the surgical suite,â&#x20AC;? page 69. AORN, Inc.). Whether data support the necessity of a hat at all, common sense would dictate that keeping hair out of the operative fieldâ&#x20AC;&#x201D;and out of the operatorâ&#x20AC;&#x2122;s eyesâ&#x20AC;&#x201D;is reasonable. Even a short-order cook knows that. The question is â&#x20AC;&#x153;how?â&#x20AC;? No systematic comparison was made among cap styles to ascertain whether the sanctioned bouffant style more effectively decreases patient exposure to a surgeonâ&#x20AC;&#x2122;s hair, dandruff or scurf (flakes of exfoliated epidermis) than other hat styles. Nor has the â&#x20AC;&#x153;one hat fits allâ&#x20AC;? standard been evaluated. Long hair slips out of bouffants. I can attest to this personally since during my training, a scrub nurse once

er we wear a traditional surgeonâ&#x20AC;&#x2122;s urgeonâ&#x20AC;&#x2122;s cap or a bouffant bonnet is not just about cap style. Will we choose to step up to the plate and wear the hat of the leader or don the hat of the subordinate? Will weâ&#x20AC;&#x201D;through our thoughtful dedication to patient careâ&#x20AC;&#x201D;set the example in the OR, or resign ourselves to being recalcitrant employees who bitterly swallow whatever pill we are administered for fear of diminishing our earnings? Greed; loss of autonomy; preferring to circumvent policies rather than authoring and being the custodians of them; longstanding indulgence of a â&#x20AC;&#x153;boys will be boysâ&#x20AC;? perception of surgeonsâ&#x20AC;&#x2122; demeanors; failure to reckon with our human limitations so that we become resentful of our demanding work; and loss of connection with the sacred intention that inspired us to pursue our calling to be doctors: These are the ways we undermine ourselves personally and professionally and diminish our financial value when we withdraw from the system. We sacrifice our integrity and our credibility when we disengage and sidestep meaningless policies ratther than challenging and reshaping them to reflect our expertise and values. We fuel the characterization of surgeon ns as disruptive, childish and disagreeaable, and justify the ever-intensifying micromanm agement of our performance aand policing by administrators, nurses, and nearly

â&#x20AC;&#x2DC;We sacrifice our integrity and ou our credibility when we disengage and sidestep meaningless policies rather than challenging and reshaping them to reflect our expertise and values.â&#x20AC;&#x2122;

anyone else inside or outside the hospital. We must find the character and conviction to creatively reinvigorate the culture of surgery, our guild, and find meaningful connections with the other professionals whose scope of work overlaps our own. We must understand that our ability, not only to respond to pointless legislation but also to assume our appropriate place in the determination of sound surgical practices, will serve us well. It will enhance our gratification by deepening our connection to our calling and make us value our work and ourselves, so that we stop agreeing to do more and more with less and less. Although the CMS hat initiative at our hospital apparently has not affected many others yet, it will. The cap is a fitting emblem of our specialty and our identity. At the end of the day, whether we figure out that one cap does or does not fit all, I intend to think critically about my value as a surgeon and an educator and to encourage my associates to do the same, and to remember our original, sacred intention that led each of us down this arduous but amazing path. Letâ&#x20AC;&#x2122;s think carefully every day about what hat we choose to wear. â&#x20AC;&#x201D;Dr. Kosinskii is an assistant professor â&#x20AC;&#x201D; of surgery in the division of colorectal surgery at the Medical College of Wisconsin, Milwaukee, and a new member of the editorial advisory board of General Surgery News.

khorty@mcmahonmed.com.

GSN Bulletin Board

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In the News VENTRAL HERNIA jcontinued from page 1

including intraoperative factors, for surgical site occurrences following open ventral hernia repair. Donald E. Fry, MD, executive vice president of Michael Pine and Associates and adjunct professor of surgery at Chicago’s Northwestern University, said the study “will hopefully provide us with some direction on how we are going to be able to optimize outcomes for quite a morbid operation.” More research is needed, he added, to assess all factors that play into infection risk, particularly admission laboratory results. The risk assessment model will require validation at other institutions. Dr. Fry, an expert in risk assessment modeling, said the study represents some of the highest-quality research to address infections in ventral hernia. Previous projects from the Ventral Hernia Working Group, a corporatesponsored group of hernia experts in the United States, and the National Nosocomial Infections Surveillance system identified multiple factors predicting patients at higher risk for surgical site occurrences or infections. These risk assessment tools, however, were incomplete, said Dr. Liang. They were not based on direct patient data, not specific to ventral hernias or failed to provide adequate stratification of

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2013

The presence of hernia patients. The presence of a class Dr. Liang and his 4 wound significanta class 4 wound colleagues set out ly increased risk for sursignificantly to create a prognosgical site occurrence, with tic ventral hernia risk an odds ratio of 8.7 (95% increased risk score based on direct confidence interval [CI], for surgical site patient data. They con3.7-24.1; P<0.001). Investiducted a retrospective assigned nine points occurrence, with an gators study of 888 patients to the presence of a class 4 odds ratio of 8.7. wound, making it the most who underwent open ventral hernia repair at important factor in the Vena single institution between 2000 and tral Hernia Risk Score. (In the Nation2010. Their study examined all surgi- al Nosocomial Infection Surveillance risk cal site occurrences to ensure all wound index, a class 4 wound is worth only one complications were captured. point, making it the same as the AmeriSurgical site occurrences were defined can Society of Anesthesiologists' score 3.) as surgical site infections; formations of Three other variables were found to siga seroma, hematoma or fistula; or wound nificantly increase ventral hernia risk: the dehiscences. creation of skin flaps, incidental or conIn all, one-third of the patients devel- comitant hernia repair and the implantaoped 415 unique surgical site occurrenc- tion of mesh. Each of these variables was es. The most common occurrence was a worth two points in the risk score. surgical site infection (21.6%), followed by The investigators grouped patients into seroma (12.1%), wound dehiscence (7.1%), three categories based on their risk score: hematoma (3.0%) and fistula (1.4%). Class I, zero points; Class II, 2 to 4 points; The investigators conducted a multivar- and Class III, three or more points. Nearly iate analysis using internal resampling to 80% of patients categorized as Class III in identify independent risk factors for sur- the study developed a surgical site occurgical site occurrences. Their methodology rence, compared with 49.6% of patients in ensured greater external validity and appli- Class II and 17.8% in Class I. cability of the model to external data sets. Dr. Liang said he and his colleagues Each risk factor was assigned a numeric now use the risk score in their assessvalue based on the odds ratio, and a clini- ment of patients with ventral hernia. They cal risk score for each patient was calculat- employ preoperative and intraoperative ed based on these factors. techniques to reduce the risk in patients

likely to develop a surgical site infection or an occurrence. Patients are encouraged to lose weight, stop smoking and improve diabetes control. In patients with wound class 4, surgeons attempt to reduce the pathology and stage repairs rather than perform singlestage repairs. They avoid use of skin flaps whenever possible, Dr. Liang said. They carefully select mesh, “as the mesh will invariably come into contact with bacteria in complicated ventral hernia repair.” Some patients should be considered for watchful waiting instead of surgery, Dr. Liang said. The authors used a receiver operating characteristic analysis to compare the Ventral Hernia Risk Score with the risk assessment tools from the Ventral Hernia Working Group and the National Nosocomial Infection Surveillance system index. The analysis showed the Ventral Hernia Risk Score for accurately predicting surgical site occurrence exceeded other tools. The investigators are organizing follow-up studies to externally validate their results. Dr. Liang disclosed that he receives a LifeCell research grant and unrestricted educational grants. Dr. Fry disclosed that he is on the speakers’ bureau for Merck, and has served as a consultant for Ethicon.

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REPORT Optimizing Patient–Ventilator Interaction: Proportional Assist Ventilation and Patient–Ventilator Synchrony Part 2 of a 2-Part Series echanical ventilation (MV) successfully extubated.2 The evalFaculty is a potentially lifesaving uation of objective and clinical intervention but is associated criteria (eg, respiratory pattern, Sanford Levine, MD with a number of complicaadequate gas exchange, hemoAdjunct Professor of Surgery tions such as pneumonia and dynamic stability, and comfort) Department of Surgery and tracheal stenosis.1 Early weanshould be used to determine SBT Pennsylvania Muscle Institute ing or liberating the critically ill success.2 Weaning failure, defined University of Pennsylvania patient from mechanical supas either the failure of a SBT or the School of Medicine port is an important clinical need for reintubation within hours Philadelphia, Pennsylvania goal because liberation results following extubation, after a sinin spontaneous breathing and gle SBT is relatively common and Catherine S. Sassoon, MD Professor of Medicine extubation.2 Weaning delays occurs in approximately 25% to are common in the ICU and may 42% of patients.6-8 Weaning failure University of California, Irvine result from patient– ventilator has a complex, multifactorial pathoDivision of Pulmonary and asynchrony (occurring in 24% physiology that may have psychoCritical Care Medicine VA Long Beach Healthcare System of patients and in ≥10% of their logical, pharmacologic, medical, Long Beach, California breaths), which may prolong and physiologic components. 2 ventilation up to 17 days and Length and difficulty of weaning exposes patients to discomfort attempts may be simple (successand increased risk for complications.2-4 Weaning delays ful first attempt), difficult (3 SBTs or as long as 7 days with prolonged MV are associated with a high cost of from initial attempt), or prolonged (failure of 3 weaning care and higher 6-month mortality rates.2,5 attempts or requiring 7 or more days of weaning after A spontaneous breathing trial (SBT) is the major the first SBT).2 A failed SBT should prompt the clinidiagnostic test used to determine if a patient can be cian to look for reversible contributing etiologies and to

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REPORT place the patient on a nonfatiguing mode of MV (either assist -control or pressure support ventilation [PSV]).2,6 Approximately 15% of MV patients require prolonged weaning and a tracheotomy may be considered if patients continue to fail to wean after 14 days.2,9 Some patients may not be able to wean or fail weaning trials and SBTs because of the sedation level. Depth of sedation in MV was found to be associated with patientâ&#x20AC;&#x201C;ventilator asynchrony and complicates weaning, impairs respiratory drive, and leads to muscle weakness.10,11 Despite the association of sedation with poor outcomes and prolonged MV, sedation may be employed in the clinical treatment of asynchrony; as demonstrated by Pohlman and colleagues, 42% of ICU patients required additional sedation due to patientventilator asynchrony.12,13 Heavy sedation affects the process of discontinuing ventilator support, underscoring a need to consider consciousness and discontinuation of sedation as part of a weaning protocol.14 Kress and colleagues demonstrated that daily interruptions of sedative infusions reduce the duration of MV and ICU length of stay.15 More recently, a no-sedation protocol was found to be associated with a decrease in ventilator days in critically ill patients.16 Earlier liberation from the ventilator is significant because MV can cause rapid and profound disuse atrophy and weakness of the diaphragm, called ventilator-induced diaphragmatic dysfunction (VIDD).17-20 Using a combination of 18 to 69 hours of complete diaphragmatic inactivity and MV, Levine and colleagues demonstrated marked atrophy of slow- and fasttwitch respiratory muscle fibers.18 To minimize the risk for VIDD, it is important to deliver appropriate partial ventilatory support that facilitates intermittent diaphragmatic contractions.19,21

From PSV to Proportional Assist Ventilation PSV is currently one of the most commonly used partial ventilatory assist modes.22 It reduces workload on respiratory muscles by generating a constant pressure that complements patient effort throughout the inspiratory period.23,24 Compared with earlier ventilatory modes, PSV gives patients more control over when to end inspiration, as the fixed level of inspiratory muscle unloading and patient triggering of the ventilator results in applied pressure (Paw ) rising to a preset level regardless of patient effort.25 However, asynchrony can still occur with PSV because patient conditions are constantly changing and flow demands vary from breath to breath.26,27 Care must be taken with PSV to avoid both insufficient support, leading to increased respiratory muscle load, and excessive support that may result in delayed cycling and other adverse effects (eg, dynamic hyperinflation, intrinsic positive end expiratory pressure [auto-PEEP]).28,29 Proportional assist ventilation (PAV) is designed to amplify patient efforts in a proportional manner without volume or pressure targets, thus optimizing patientâ&#x20AC;&#x201C;ventilator synchrony.30,31 PAV delivers ventilatory assistance based on the patientâ&#x20AC;&#x2122;s respiratory effort, which is clinically valuable because inspiratory effort is variable and, therefore, the level of assistance should vary with it.22,25 PAV is advantageous because 2

it eliminates the need for clinicians to set traditional ventilator parameters (ie, tidal volume, flow rate, inspiratory time, and respiratory rate); the only clinician-determined setting required with PAV is percent support.24,32,33 The necessity for the measurements of respiratory elastance (or compliance) and airway resistance, however, had been an obstacle to widespread clinical use of conventional PAV.31,34-37 More recently, the PAV+ software option was introduced which automatically measures the patient respiratory elastance and airway resistance. The PAV+ software estimates resistance and compliance every 4 to 10 breaths.38 The PAV+ software option has greatly helped to extend the usefulness of PAV technology from research to clinical settings.

Benefits of PAV PAV was demonstrated, in early pathophysiologic studies, to decrease work of breathing (WOB), increase tidal volume, and decrease peak Paw in intubated patients without chronic obstructive pulmonary disease (COPD) during weaning from MV.39,40 Similarly encouraging results were found for PAV in intubated COPD patients including improved minute ventilation, decreased dyspnea, and reduced WOB.39,41 Many studies have shown that PAV allows for improved adaptation of the ventilator to the changing flow demands of the patient, thus improving synchrony between patients and ventilator.42,43 PAV also has been shown to significantly reduce peak inspiratory pressure over a 24-hour period.44 Greater muscle effort is required, and more pronounced patient discomfort has been observed in response to added respiratory load during PSV compared with PAV.22 A retrospective analysis of data from a previous randomized controlled trial demonstrated that PAV+ is associated with fewer interventions in terms of ventilator settings and sedative dose changes compared with PSV.45 A randomized study in the ICU setting demonstrated PAV+ to be an efficient mode of ventilatory support compared with PSV.43 Patients were randomized to receive either PSV (n=100) or PAV+ (n=108) for 48 hours unless patients met predefined criteria for switching to controlled modes or for breathing without assistance.43 Failure rate was significantly lower with PAV+ than with PSV (11% vs 22%, respectively; P=0.040), and the proportion of dyssynchronies was significantly lower in the PAV+ group (5.6% vs 29% respectively; P= 0.001).42 The probability of remaining on spontaneous breathing, instead of switching to CMV, was significantly increased with PAV+ when compared with the PSV group (P= 0.041; Figure).43 The ventilating pressure remained below 30 cm H 2O in 98.2% of measurements in PAV+. This is clinically important because it is recommended that static end-inspiratory airway pressure (Pplat) be maintained below 30 cm H2O to minimize risk for ventilator-induced lung injury.43,46 Short-term respiratory load compensation in critically ill patients may be more efficient during PAV+ than during PSV.32 Kondili and colleagues examined an index of neuroventilatory coupling (the VT to pressure-time ratio product of the diaphragm) of each breath for patterns of respiratory load compensation in response to added mechanical respiratory load in 10 critically ill patients on MV. With PAV+, this

REPORT

Cautions When Using PAV Despite favorable effects that have been demonstrated with PAV and PAV+ (collectively, PAV hereafter), it has limitations. Because the assist varies directly with the intensity of patient effort, and the patient’s respiratory muscles drive the ventilator, PAV must be used with caution in patients with very low respiratory efforts (eg, depression of ventilation, central apneas).25 PAV requires an intact, responsive central controller to maintain an adequate pCO2 and pH. Although patients with altered respiratory drive may be ventilated adequately with PAV, they may have trouble triggering the ventilator.25 PAV is contraindicated if the patient’s central ventilatory drive is unstable due to excessive sedation, central depression of ventilation (eg, brain injury), or central apnea.25 The clinician must correct causes of inefficient drive or switch to a mode with a set rate in the presence of very low respiratory efforts or apnea.2,25 Patient comfort is an important clinical consideration with PAV, as it is with PSV.49.50 Air leaks have been associated with patient–ventilator asynchrony, particularly in noninvasive ventilation, and should be part of the differential when troubleshooting respiratory distress in a patient receiving MV.51 The ability of PAV to compensate for leaks must be evaluated before use as it may vary between ventilator models.33 PAV use may be limited by leak sensitivity, excessive pressure potential (ie, the runaway phenomenon), and the consequences of dynamic hyperinflation.37,52 Reducing the magnitude of dynamic hyperinflation should be a priority. Bronchodilators or corticosteroids may be used, and external positive end expiratory pressure (PEEP) could be used to counterbalance auto-PEEP.37 Care must be taken, especially in critically ill patients, to avoid treating the lung as if elastance and resistance are linear; alinearity of pressure–volume and pressure– flow relationships may cause volume-assist or flow-assist to be set inappropriately.37 PAV is better suited for responding to changing lung mechanics compared with PSV; however, PAV

is similar to other ventilatory modes in that it does not compensate for or overcome the effects of auto-PEEP.33 PAV+ software is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight is at least 55 lb or 25 kg. Patients must be intubated with endotracheal or tracheostomy tubes with an internal diameter of 6 to 10 mm. Patients must have satisfactory neural-ventilatory coupling along with a stable, sustainable inspiratory drive.38

More Tips for Using PAV+ Although PAV+ has been associated with fewer required manipulations of ventilator settings relative to PSV, clinicians generally must individualize ventilatory support based on patient comfort.25,45 A basic PAV application principle is to set PAV at 70% assist, a support level at which distress is uncommon, and to make initial adjustments based on respiratory frequency, using PEEP to overcome auto-PEEP and reducing support gradually (based on patient comfort and with a goal of moving toward a SBT).37 The manufacturer also recommends caution when choosing support values higher than 80%, which may be uncomfortable for the patient.2,25,38 Data monitored and displayed by the PAV+ software include lung compliance and elastance, auto-PEEP, airway resistance, estimated total resistance, spontaneous inspired VT, and normalized rapid shallow breathing index.38 WOB is displayed with PAV+ in the form of a bar graph, with the sum being 100% of the work and the respective work by the patient and ventilator partitioned based on percent work setting and patient variables.25,38 Having multiple patient data readily available through the PAV+ screen display can aid in clinical decision-making that potentially may reduce delays in liberation of patients from MV as a consequence of improved synchrony.

Probability of Remaining On Spontaneous Breathing

index remained relatively independent of load, in contrast to PSV, and the magnitude of load-induced VT reduction and breathing frequency increase was significantly smaller with PAV+ than during PSV.32 Transdiaphragmatic pressure was measured breath-by-breath, per minute, and per liter of ventilation; these values were significantly lower with PAV+ than those with pressure support ([PS]; 5.13±3.7 vs 6.13±3.4 cm H2O; 120.9±78 vs 165.6±77.5 cm H2O/min; and 18.71±15.1 vs 24.36±16.4 cm H2O/L, respectively).32 Some evidence suggests that sleep architecture may be improved with PAV compared with PSV. In a small randomized crossover clinical study that evaluated PAV in 13 patients during weaning from MV, patients receiving PSV had more sleep disruptions per hour (16 compared with 9 in the PAV group; P<0.02) and overall sleep quality was improved in the group receiving PAV.47 Fewer asynchronies were detected per hour in the PAV group (23.7±15.4 vs 52.9±59.2; P=0.0001); this correlated with the number of arousals per hour (P<0.05).47 In a study that evaluated sleep architecture in critically ill patients receiving PAV+, sleep quality was not adversely affected by PAV+ despite the large number of brief end-inspiratory occlusions.48

1.0

0.9 0.8

0.7 0.6

PS PAV+

Log-rank P=0.041

0.5 0

Hours After Randomization Patients at risk, n PS

100

PAV+

108

101

Figure. Kaplan–Meier estimates of probability of remaining on spontaneous breathing (assisted or unassisted) in patients randomized to PS and PAV+. PAV+, proportional assist ventilation with load adjustable gain factors; PS, pressure support Reprinted with permission from Xirouchaki N, et al. Intensive Care Med. 2008;34(11):2026-2034.

REPORT Conclusion PAV is designed with the aim of improving airflow and phase synchrony between patient and ventilator. In addition to being a user-friendly ventilatory mode, PAV has demonstrated efficacy in reducing the frequency of sedative dosing changes, improving respiratory muscle function, reducing peak pressures, and reducing WOB by shifting the

determination of the most appropriate breathing pattern to the patient, thus potentially resulting in a more timely liberation from the ventilator. PAV+, with its capability of automatically measuring respiratory compliance and airway resistance, has greatly helped to extend the usefulness of PAV technology from research to clinical settings.

References 1. Lermitte J, et al. Contin Educ Anaesth Crit Care. 2005; 5(4):113-117.

27. Tokioka H, et al. Anesth Analg. 2001;92(1):161-165.

2. Boles JM, et al. Eur Respir J. 2007;29(5):1033-1056. 3. Thille AW, et al. Intensive Care Med. 2006;32(10):1515-1522.

29. Leung P, et al. Am J Respir Crit Care Med. 1997;155(6): 1940-1948.

28. Sinderby C, et al. Chest. 29(2):329-342.

4. Kollef MH, et al. Crit Care Med. 1997;25(4):567-574.

30. Sinderby C. Am J Respir Crit Care Med. 2003;168(7):729-730.

5. Seneff MG, et al. Crit Care Med. 2000;28(2):342-350.

31. Delaere S, et al. Intensive Care Med. 2003;29(6):949-954.

6. Esteban A, et al. N Eng J Med. 1995;332(6):345-350.

32. Kondili E, et al. Intensive Care Med. 2006;32(5):692-699.

7. Vallverdu I, et al. Am J Respir Crit Care Med. 1998;158(6): 1855-1862.

33. Kacmarek RM. Respir Care. 2011;56(2):140-148.

8. Esteban A, et al. Am J Respir Crit Care Med. 1999;159(2): 512-518.

35. Ambrosino N, et al. Thorax. 2002;57(3):272-276.

9. Masoudifar M, et al. Adv Biomed Res. 2012;1:25. 10. de Wit M, et al. J Crit Care. 2009;24(1):74-80.

37. Georgopoulos D, et al. Int J Intensive Care. 2007; Autumn:74-83.

11. Epstein S. Respir Care. 2011;56(1):25-38.

38. Data on file, Covidien.

12. Kollef MH, et al. Chest. 1998;114(2):541-548.

39. Grossbach I, et al. Crit Care Nurse. 2011;31:30-44.

34. Jolliet P, et al. Crit Care. 2006;10(6):236. 36. Thille A, et al. Clin Pulm Med. 2007;14(6):350-359.

13. Pohlman M, et al. Crit Care Med. 2008;36(11):3019-3023.

40. Navalesi P. Crit Care. 2011;15(181):1-2.

14. Girard TD, et al. Lancet. 2008;371(9607):126-134.

41. Ranier VM, et al. Anesthesiology. 1997;86(1):79-91.

15. Kress JP, et al. N Eng J Med. 2000;342(20):1471-1477.

42. Mitrouska J, et al. Eur Respir J. 1999;13(4):873-882.

16. Strom T, et al. Lancet. 2010;375(9713):475-480.

43. Xirouchaki N, et al. Intensive Care Med. 2008;34(11): 2026-2034.

17. Hermans G, et al. Crit Care. 2010;14(4):1-10. 18. Levine S, et al. N Eng J Med. 2008;358(13):1327-1335. 19. Sassoon CS, et al. Am J Respir Crit Care Med. 2004; 170(6):626-632. 20. Vassilakopoulos T, et al. Am J Respir Crit Care Med. 2004;169(3):336-341. 21. Vassilakopoulos T, et al. Crit Care. 2006;10(1):204. 22. Grasso S, et al. Amer J Respir Crit Care Med. 2000; 161(3 Pt 1):819-826. 23. Prinianakis G, et al. Intensive Care Med. 2003;29(11): 1950-1959. 24. Brochard L, et al. Am J Respir Crit Care Med. 1994; 150(4):896-903.

44. Fisher DF. Presented at: 42nd Annual Meeting of the American Burn Association; March 9-10, 2010; Boston, MA. 45. Xirouchaki N, et al. Intensive Care Med. 2009;35(9): 1599-1603. 46. The Acute Respiratory Distress Syndrome Network. N Eng J Med. 2000;342(18):1301-1308. 47. Bosma K, et al. Crit Care Med. 2007;35(4):1048-1054. 48. Alexopoulou C, et al. Intensive Care Med. 2007;33(7): 1139-1147. 49. Prinianakis G, et al. Eur Respir J. 2004;23(2):314-320. 50. Vignaux L, et al. Intensive Care Med. 2009;35(5):840-846.

25. Davies J. Essential Practices in Respiratory Care. 2011.

51. Santanilla JI, et al. Emerg Med Clin North Am. 2008; 26(3):849-862.

26. Beck J, et al. App Technol Mech Ventilation. 2011:1-5.

52. Passam F, et al. Respiration. 2003;70(4):355-361.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Covidien, 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 ÂŠ 2013, 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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Disclosures: Drs. Levine and Sassoon reported no relevant financial disclosures.

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REPORT July 2013

Improving Outcomes in Open Colorectal and Gynecologic Procedures Using the LigaSure Impact™ Instrument Faculty: Robert E. Bristow, MD, MBA Professor and Director Division of Gynecologic Oncology Department of OB/GYN UC Irvine Medical Center Orange, California Warner Huh, MD Professor Margaret Cameron Spain Endowed Chair in Obstetrics/Gynecology Division of Gynecology Department of OB/GYN University of Alabama at Birmingham Birmingham, Alabama Raffaele Bruno, MD Assistant Clinical Professor in OB/GYN Boston University School of Medicine Boston, Massachusetts Director of Section of General Gynecology and Reconstructive Pelvic Surgery Department of Gynecology Lahey Clinic Foundation, Inc. Burlington, Massachusetts Laurence Sands, MD Professor of Clinical Surgery University of Miami Miller School of Medicine Miami, Florida Eduardo Garcia-Granero, MD Professor of Surgery Head of Section Coloproctology Unit Hospital la Fe University of Valencia Valencia, Spain Paris Tekkis, MBBS, FRCS Professor of Colorectal Surgery Imperial College of London The Royal Marsden Hospital London, United Kingdom Aneel Bhangu, MBChB, MRCS Imperial College of London The Royal Marsden Hospital London, United Kingdom Distributed by McMahon Publishing

Introduction Recent advances in open and laparoscopic surgery have enabled surgeons to perform complicated procedures across surgical specialties, including gynecology and gastroenterology, with improved efficiency while optimizing clinical outcomes.1,2 Although a variety of conventional techniques, including clips, sutures, staples, and energy-sealing devices, have been used for vessel ligation in gynecologic and colorectal procedures,3,4 these methods may present a number of challenges including prolonged operating time, increased risk for blood loss, and increased costs. For example, the use of sutures can be time-consuming given the need to clamp, cut, and ligate the vessel.5 For gynecologic surgeons, procedures, including hysterectomies, are optimized by using surgical instruments that enhance access and visibility when ligating vessels, while minimizing blood loss.4 Raffaele Bruno, MD, assistant clinical professor in obstetrics and gynecology at Boston University School of Medicine, whose practice comprises mainly pelvic organ prolapse and uro-gynecology, indicated that when he was in training, vessel ligation was limited to clamps and suture ties, and basic bipolar instrumentation. Warner Huh, MD, professor in the Division of Gynecologic Oncology at the University of Alabama at Birmingham,

recognized the challenges when performing gynecologic procedures and expressed the need for instrumentation that could help him perform the cytoreductive procedures that make up a substantial proportion of his work. “In ovarian cancer, where women have advanced disease, we’re trying to remove as much disease as possible,” he said. For surgeons performing colorectal procedures, such as a laparoscopic colectomy, mobilization and devascularization of the colon and its mesentery are key parts.3 In the past, Laurence Sands, MD, professor of clinical surgery at the University of Miami Miller School of Medicine in Florida and a practicing colorectal surgeon, had used clips and stapler devices, which were found to be cumbersome and more expensive, respectively. Paris Tekkis, MBBS, professor of colorectal surgery at the Imperial College of London, considered scissors, suture ties, and suture ligation the gold standard for attaining hemostatic control in open colorectal surgery; however, he noted that these methods have some serious drawbacks. “They can be timeconsuming and involve leaving foreign material inside the body, which can be a source of infection,” he said. In addition to potentially introducing foreign particles, most of the mechanical methods can be costly for patients and institutions.4 Gynecologic and colorectal surgeons

REPORT face a number of challenges when performing procedures, but they can benefit from new devices that enhance ease of use and visibility, while maintaining hemostasis and containing costs. Surgical technology has evolved to include energy-based sealing devices that are easier to maneuver and ensure secure sealing to minimize blood loss.4 Dr. Sands, a colorectal surgeon for 15 years, is always on the lookout for products that have the potential to advance surgery for both open and laparoscopic procedures. “I think the advances in laparoscopic and open surgical instrumentation have progressed significantly over the years, and the best part is that we no longer need to use suture ties because we have such great vessel-sealing devices,” he said. “I think this is revolutionizing both laparoscopic and open surgery.” Indeed, the prominent use of energy-based sealing devices facilitates the ability to optimize surgical outcomes. “For patients with ovarian cancer, we often do a lot of ancillary surgery like bowel resections, colon resections, splenectomies, and other procedures that would require a vessel-sealing device,” said Dr. Huh. According to Dr. Sands, “Vessel-sealing devices are really well suited for laparoscopic procedures. Every new device that comes out seems to be able to handle a larger blood vessel, provide very good sealing of the blood vessels, and provide a bloodless field. As new devices come out, they get better because they have less thermal spread than they used to,” he concluded. With the availability of LigaSure™ technology, Covidien has provided surgeons with an array of energy-based tissueand vessel-sealing devices that facilitate navigation throughout the respective vessels while ensuring secure sealing and hemostasis. With Covidien’s LigaSure Impact™ instrument, surgeons possess an open vessel-sealing tool that integrates ligation with vessel sealing of up to and including 7 mm in diameter, resulting in faster operating times and lower risk for blood loss compared with conventional techniques.5

Dr. Sands presently uses LigaSure™ technology, “for just about every laparoscopic and open procedure that I do,” he said. “I think right now this is one of the best devices out there. The HARMONIC™* scalpel is a good device, and the ENSEAL™*, which is used for both open and laparoscopic procedures, is a good hemostatic device, but it’s a bit cumbersome and takes more experience to learn to use. One of the benefits of the LigaSure™ [technology] is that you learn how to use the device quickly. I think it’s really going to help our surgical cases; there’s no question about it.” “HARMONIC™* scalpels are an alternative technologyrelated device, but they can only seal vessels as they cut,” noted Dr. Tekkis. “The LigaSure Impact™ [instrument] is our preferred device, as it is versatile and reliable, allowing for a wide range of hemostatic maneuvers and dissection techniques with speed and reliability.” Dr. Tekkis and his colleague, Aneel Bhangu, MBChB a colorectal fellow at the Royal Marsden Hospital in London, have used the LigaSure Impact™ instrument in more than 100 exenterative procedures for advanced rectal cancers. They also turn to the LigaSure Impact™ instrument for resections in inflammatory bowel disease and other colonic resections.

The LigaSure Impact™ Instrument With the LigaSure Impact™ instrument, the ForceTriad™ energy platform with proprietary TissueFect™ sensing technology monitors changes in tissue impedance 3,333 times a second, and adjusts energy output accordingly to deliver the appropriate amount of energy for the desired tissue effect (Figure 1). “As energy is forced through that tissue, the tissue resists the flow of electrons, thus generating heat that does the work in electrosurgery, almost like a friction effect,” explained Dr. Bruno. “In real time, it continually changes the energy it delivers to create just enough heat in the tissue to denature the proteins, while at the same time, the pressure [put] on the treated tissue between the jaws of

Figure 1. The LigaSure Impact™ instrument cuts and seals vessels up to and including 7 mm in diameter. 2

REPORT the instrument fuses the vessels and tissue into a monolayer seal.” Once the seal is completed, the cooling cycle begins in which the device automatically stops delivering energy, and an audible sound indicates the end of the cycle.4 “At that point, you can go ahead and pull the trigger on the Impact™ [instrument], which releases a protected blade in the jaws down the middle of the seal, providing proximal and distal hemostasis,” said Dr. Bruno. The appropriate amount of pressure along with the delivery of electrical energy will consistently create reliable burst strength seals.4 In turn, these burst strength seals are able to withstand rupture at 3 times the normal systolic blood pressure.6 The average time to create the seal is 3 to 5 seconds.4 The LigaSure Impact™ instrument features a blade that cuts independently of sealing (Figure 2). With the “LigaSure™ Extend and Max [devices], once you sealed the tissue you had to remove the device and attempt to cut the seal down the middle using a scalpel or scissors. The LigaSure Impact™ instrument has a trigger in the handle that, when pulled, releases the blade through the center of the jaw to cut the seal, so you don’t have to seal the tissue, remove the sealing device, and then cut down the center of the seal,” explained Dr. Bruno. The sealing and cutting features of the LigaSure Impact™ instrument exist independently, so a surgeon can choose only to seal a vessel when dissection is not required. “It is important that I can seal without dividing,” said Eduardo Garcia-Granero, MD, professor of surgery and head of the coloproctology unit at the Hospital la Fe in Valencia, Spain. “I also have a feeling

that the division is more precise and less traumatic.” The surgeon’s ability to lock the jaw of the device before sealing ensures that the instrument is placed exactly where it needs to be. “The main risk is not noticing damage to the bowel, which is a serious complication,” said Dr.Tekkis. “The locking function of the LigaSure Impact™ [instrument] allows its placement to be checked before sealing to ensure that the bowel, blood vessels, or other vital structures are not accidentally caught.” LigaSure™ technology has evolved to provide an innovative device that accounts for earlier challenges with the predecessors. “When you’re using a vessel-sealing device, you want to activate the device without significant tension on the tissue, because if you apply tension while creating the seal, the tissues can tear,” said Dr. Bruno. With the LigaSure™ 5 mm blunt tip instrument, the jaws of the device have been lengthened, and they incorporate grooves to reduce the degree of tissue slippage. “With the grooves and longer jaw in laparoscopy, you’re able to grasp the tissue, minimize the tension, and create the seal,” said Dr. Bruno. “The LigaSure Impact™ [instrument] brings many benefits to our operating environment,” Dr. Tekkis said. “We are often dissecting deep pelvic structures. The pelvis is a confined space, narrower in men than in women. Traditional dissection with scissors and diathermy can be difficult due to this lack of space, leading to increased bleeding, longer operating times, and increasing chance of tumor perforation.” Dr. Tekkis finds the long reach, narrow rotating shaft, and angled jaw of the LigaSure Impact™ instrument

Figure 2. The LigaSure Impact™ instrument sealing an isolated vessel. 3

REPORT beneficial in this setting. “It allows for rapid dissection in these confined spaces, and the rotating curved head allows for a more ergonomic dissection around the rectal planes at the pelvic floor,” Dr. Tekkis said. “The Impact™ [instrument] is [also] lightweight and easy to handle.” Robert E. Bristow, MD, professor and director of the Division of Gynecologic Oncology at the University of California Irvine Medical Center, finds the shape of the instrument enhances its ease of use. “The fact that it has a curvature to it really facilitates our operating deep in the pelvis and in the upper abdomen,” he said. “There’s a curvature to the pelvis that you need to accommodate for.” Dr. Bruno found less blood loss with the LigaSure Impact™ instrument than with the clamp and suture approach. “When you’re doing multiple cases in a day, for instance, 3 or 4 major vaginal surgeries, when you get bleeding with clamp and suture you have to stop and suction the blood. This can become quite fatiguing by the end of the day,” he said. “Because of the ability of the LigaSure Impact™ [instrument] to cut down the center of the seal, thus providing hemostasis both proximally and distally on a blood vessel, you don’t get any bleeding, so there is no stopping and suctioning and reapplying a clamp. This makes the surgery go a bit more comfortably.”

Achieving Hemostasis With the LigaSure Impact™ Instrument

a reliable seal for the type of vessel that you are trying to seal in your surgery.” Other surgeons concur. “A major goal of these devices should be to provide adequate hemostasis,” said Dr. Sands, who is comfortable using the LigaSure Impact™ instrument on the inferior mesenteric artery and vein, and has used it on even larger vessels in the test labs. “The Impact™ [instrument] works fine on the 2 large vessels I deal with. If the vessels are calcified, however, it may be difficult to get a good seal, but that’s probably true with any device out there,” he explained. Dr. Bristow is confident with the LigaSure Impact™ [instrument’s] ability to seal the largestsized vessels for which it is indicated. “It’s very high within the product specifications, up to 7 mm,” he said. Dr. Tekkis also considers reliable hemostasis the most important characteristic of a vessel-sealing device. “The other features are beneficial, but reliable coagulation is the most important. The LigaSure Impact™ [instrument] has become an indispensable tool during our [open] procedures, and I think it would be useful for a range of colorectal procedures where bleeding is problematic,” he said. “This is especially true for deep pelvic surgery and in postradiotherapy tissues, but even in relatively simple colon resections, LigaSure Impact™ [instrument] may have a substantial time-saving role.”

Saving Time and Minimizing Blood Loss

Without question, sealing quality is the most important characteristic of any vessel-sealing device. “If there is any doubt about the security of the seal, everything else can get thrown out the window,” said Dr. Bruno. “We can talk about plume production, lateral thermal spread, and other concerns, but the key thing is the seal—you have to have

The degree to which superior hemostasis results in time savings is immediately apparent to those who use the LigaSure Impact™ instrument, especially when compared with traditional clamping and tying or other energy-sealing devices (Figure 3).4,5,7-9 In addition, the use of LigaSure™ technology has proven to reduce overall blood loss.4

Operative time, min

100

907 75.28

80 4

574

619 53.65

52.5 5

39.1

29.28

309

20 0

LigaSure™

Suturing

Figure 3. Comparison of operative time using LigaSure™ versus standard suturing for hemostasis during vaginal hysterectomy: results from 5 studies. Based on references 4,5, and 7-9.

REPORT Table. Blood Loss Comparison Between LigaSure™ Technology and Ultrasonic Coagulating Shears for Patients Undergoing Colectomy Procedure

LigaSure™, mL

Ultrasonic Coagulating Shears, mL

P-Value

Right colectomy

115

370

0.001

Left colectomy

150

455

0.001

Based on reference 12.

fallopian tubes, is considerably less than [with] traditional clamp and suture,” he said. In vaginal hysterectomy, removal of the ovaries is particularly technically challenging given the narrow, conical shape of the vagina, he explained. “The LigaSure Impact™ [instrument] facilitates this. In plenty of cases we felt more comfortable removing the tubes and ovaries with the LigaSure Impact™ [instrument] than with using traditional clamp and suture,” Dr. Bruno said. “The technology does reduce the time required to do many of these procedures that would otherwise have to be done with clamps, cutting, and suture-ligating pedicles; thus, patients end up spending less time under anesthesia, and I think the more reliable control of the vascular pedicles improves patient safety and reduces blood loss,” he said. Dr. Garcia-Granero agreed, “The LigaSure Impact™ [instrument] shortens the operation time and diminishes the blood loss.” In a study of 100 patients undergoing a colectomy using ultrasonic coagulating shears or LigaSure™ technology, results showed patients experience reduced mean blood loss, as well as reduced operating times (Table).12 The LigaSure Impact™ instrument also provides significant time-saving benefits when compared with other

Seal-Time Comparison 8 7

Mean Seal Time, sec

Dr. Bristow’s initial interest in the LigaSure Impact™ instrument stemmed mainly from a desire to streamline his procedures, including hysterectomies for both benign and malignant indications; division of ovarian vessel pedicles and uterine pedicles and the cardinal ligament; simple and radical hysterectomy for cervical cancer; upper abdominal procedures for metastatic or recurrent ovarian cancer; total omentectomy; blocked splenectomy; and peritonectomy. “I was motivated to see if I could improve the speed and reduce blood loss in the procedures that I perform,” he said, noting that the LigaSure Impact™ instrument has addressed both concerns. “I think sutureless surgery makes a lot of sense,” noted Dr. Bristow. “It offers a greater level of predictability and security of your vascular pedicles than traditional suture surgery. Security of the vascular pedicle division is associated with lower blood loss, and less risk for intraoperative and postoperative hemorrhage, which translates to a lower likelihood of transfusion.” Studies show that LigaSure™ technology plays an intricate role in reducing the operating time for gynecologic and colorectal procedures.4,10,11 In a study of 54 patients with benign pelvic disease, the patients were randomized to undergo vaginal hysterectomy using clamp and suture or the LigaSure Impact™ [instrument] with the ForceTriad™ energy platform. Results showed a 33% difference in operating time with operating time being shortened in the LigaSure Impact™ instrument group (38 vs 57 minutes).10 Additional results showed a 47% difference in the reduction in blood loss for patients in the LigaSure Impact™ instrument group compared with the clamp and suture group (53 vs 100 mL, respectively).10 For patients undergoing abdominal hysterectomy, the results proved to be comparable. In a study of 105 patients randomized for surgery with clamp and suture or the LigaSure Impact™ instrument, there was 30% difference in the operating time (50 vs 35 minutes, respectively), and 34% difference in the amount of blood loss (122 vs 80 mL, respectively). Additionally, results showed a reduction in the hospital length of stay for patients in the LigaSure Impact™ instrument group (2.6 vs 3.5 days, respectively).11 Dr. Bruno has been using the LigaSure Impact™ instrument for approximately 4 years and is now completing a paper comparing the instrument with traditional clamp and suture in vaginal and abdominal hysterectomies. “We have some pretty exciting data. We basically found that the operative time, particularly in vaginal surgery, for both the vaginal hysterectomy and the removal of the ovaries and

6 5 4 3 2 1 0

LigaSure Impact™

Ethicon ENSEAL™ G2

Figure 4. Sealing tissue using the LigaSure Impact™ instrument LF4200 versus the ENSEAL G2™* Super Jaw. From reference 13.

REPORT energy-sealing devices. Recent evidence also has shown the LigaSure Impact™ instrument to be significantly faster in sealing and cutting across different tissue thicknesses when compared with the ENSEAL G2™* Super Jaw (Figure 4).13 To the extent that the new technology increases the speed with which the procedure can be conducted safely, patients spend less time under anesthesia. “It also removes the potential impact of having some sort of foreign body remaining in the abdominal pelvic cavity for an indeterminate amount of time, depending on what type of suture material you use,” said Dr. Bristow.

Thermal Profile Unlike the working blades of some energy-based sealing devices, the jaws of the LigaSure Impact™ instrument are insulated on the outside, which reduces the risk for burns and heat damage to both the surgeon and the patient. Dr. Huh recalled a burn he received working with a HARMONIC ACE during a laparoscopic procedure. “As I pulled it out, the blade touched my gown and my hand and I got burned,” he said. “The problem with the ACE™* is that it has an exposed, active blade. You are more likely to burn yourself inadvertently with other devices than you are with the Impact™ [instrument], where the heat is on the inside of the jaw.” As for the potential of the LigaSure™ Impact instrument to reduce the risk for thermal injury to patients, Dr. Huh feels that rests largely on the skills of the surgeon. “If you use any device inappropriately, you’re going to have an injury.” He estimates he has used the LigaSure Impact™ on roughly 20,000 separate applications over the course of his career and has not been overly concerned with its temperature profile one way or the other. “The earlier sealing devices created enough heat in a second or 2 that you had to pull your fingers away from the jaws of the instrument,” said Dr. Bruno. The LigaSure Impact™ instrument, however, features insulated jaws that confine the energy between the seal plates. “You can put your fingers on the jaws now and not feel any heat. The heat you do feel is primarily from the steam or plume that is generated.” This can be resolved, he noted, by removing the steam with the suction device. Dr. Bristow takes precautions that reduce the risk for self-injury or injury to operating room staff even further. “I never put the Impact™ [instrument] down without closing or relocking the jaws,” he said. “I have no recollection of handling open jaws during a case because as soon as the pedicle is closed, the jaws get closed again and the instrument is set to the side.” Dr. Garcia-Granero is greatly appreciative of the low thermal profile of the LigaSure Impact™ instrument, particularly when he is working near bowel or ureters. “It is essential,” he said. “[The Impact instrument] means to seal and divide without harming critical structures such as the ureters and the nerves of the lateral pelvis. It is important to me to preserve hypogastric nerves and plexus, responsible for the sexual and urinary function of my patients.” 6

For Drs. Tekkis and Bhangu, the lower thermal profile of the LigaSure Impact™ instrument ensures that they can work safely near large arteries, veins, and ureters. “We can progress faster but with the same level of confidence,” they said. “We often need to dissect very close to the ureters. The LigaSure Impact™ instrument jaws allow us to skeletonize the ureter in the ureteric plane while sealing the small bleeding vessels as we proceed.” Dr. Bristow, too, appreciates the LigaSure Impact™ instrument’s cooler temperature profile during gynecologic procedures near such critical structures as the uteroovarian or infundibulopelvic ligament. “It is very important to us, particularly in pelvic operations when we’re operating in close proximity to the ureters, both at the pelvic rim for the ovarian vessels and on the uterine pedicles and the cardinal ligament area, to know that we are not going to get any significant degree of thermal spread from the device that might injure those structures,” he said. “Similarly in the upper abdomen, when we’re doing an omentectomy and are in very close proximity to the greater curve of the stomach, a large degree of thermal spread could weaken the wall of the stomach and lead to potentially catastrophic injury,” said Dr. Bristow. “So having control and predictability of the thermal spread is a key feature in the types of surgery that we do.” Too much heat near the ureter also can result in a catastrophic injury, explained Dr. Bruno. “You could cause enough damage that the ureter is compromised. You may not see the damage initially because the tissue is still intact, but it would break down in several days to a week,” he said. “Then you could have a loss of urine either into the abdomen or through the vagina depending on where the ureter has been injured.” Recent evidence indicates that the Impact instrument is significantly cooler than ENSEAL G2™* Super Jaw (Ethicon Endo-Surgery), with the LigaSure Impact™ instrument cooling faster during multiple applications (Figure 5).13

Minimizing Postoperative Pain According to Dr. Huh, evidence indicates patients may have less postoperative pain when their surgery is conducted with the LigaSure Impact™ instrument than if they had undergone a procedure using sutures. “This is largely due to the inflammatory reaction to the foreign body of the suture,” he said. “You don’t have that sort of foreign body effect when you use any of the energy-based devices.” In conducting a comparison of LigaSure Impact™ instrument to suturing for a paper on open and vaginal hysterectomy, Dr. Bruno and colleagues have been able to provide a somewhat more objective measure of pain in their patients. “We looked at VAS (visual analog scale) pain scores 24, 48, and 72 hours after surgery. Compared with patients in the clamp and suture group, the patients in the LigaSure Impact™* [instrument] group had significantly lower

REPORT Jaw Temperature Cool Down Comparisona LigaSure Impact™

Ethicon ENSEAL™ G2 (Metallic Surface)

Ethicon ENSEAL™ G2 (PTC)

Time, sec Performance based on side view of devices after 6 activations in porcine preclinical model.

Figure 5. Cooling temperatures of the LigaSure Impact™ Instrument LF4200 versus ENSEAL G2™* Super Jaw. a

When compared to Ethicon ENSEAL™* G2 Super Jaw Sealer Divider as part of performance evaluations of sealing time, sealing temperature, sealing cool down time, and handle force closure in porcine in vivo and in vitro models (Covidien Internal Testing, Report No’s. R0027701 and R0031770 performed February 2012 and R0031782 performed July 2012).

PTC, positive temperature coefficient From reference 13.

analog pain scores,” he said, noting that this was only in the group that underwent vaginal hysterectomy. “We think that’s because the main source of pain in the patients [undergoing open hysterectomy] is the abdominal incision, which you don’t have in vaginal surgery.”10

Next Steps in Innovation As advanced as the LigaSure Impact™ instrument is, technological innovation is a series of progressions, and there is always room for improvement. Clinicians may benefit from modifications that could enhance precision control. “At times, the activation button is easily pressed as it is very sensitive,” noted Dr. Sands. “Improvements to the force needed to activate the instrument would be helpful.” Dr. Bristow added, “It would be an advantage if the LigaSure Impact™ instrument’s grip were less bulky.” Additionally, Dr. Sands noted that although the device is not heavy, “lighter is always better so as not to cause surgeon fatigue upon instrument exchange.” Although he considers the current device easy to use, Dr. Sands thinks one improvement could be reducing the number of steps needed to use it. “It’s a multifiring device. Combining some of the steps could make it a little easier to use,” he said. “But for the most part, I think it is really well designed, well suited to what I do. At this point, it’s my mainstay device.”

Training and Financial Implication of the LigaSure Impact™ Instrument According to Dr. Huh, “Covidien has been able to translate the surgeon’s needs into its technology.” “I think LigaSure™ technology, particularly the Impact™ [instrument], is a game changer for open surgery. It has completely revolutionized how I approach my surgeries mainly because of the ease of use, speed, and reliability,” he said. “You rarely come upon a device that changes the paradigm by which you operate, and this is one of those technologies, mainly because people do not have to suture anymore,” Dr. Huh said. “We can use it on almost everything we do. You seal, you cut, and that process takes about 3 to 4 seconds.” Dr. Bruno suggests that surgeons curious about the LigaSure Impact™ instrument but perhaps not convinced that it will truly benefit them, make a side-by-side comparison by using the LigaSure Impact™ instrument on one side of a hysterectomy and their usual technique on the other side. This approach allows the surgeon to see the contrast between the 2 while also providing the opportunity to train with the new device. “If they’re doing an abdominal hysterectomy with bilateral salpingo-oophorectomy, for example, when removing the ovary they may use the LigaSure Impact™ [instrument] on one side and do the rest of the surgery with traditional

REPORT clamp and suture. That way they may periodically inspect the sealed pedicle as the surgery progresses, and can feel confident that the seal is secure and reliable,” he said. Now training others, Dr. Bruno relies on both the LigaSure Impact™ instrument and traditional clamp and suture for vaginal hysterectomies and salpingo-oophorectomies and in abdominal cases to ensure that new surgeons learn both techniques. But his preferred instrumentation is the LigaSure Impact™ instrument because of the time-savings, less pain, and the reliability of the seals it creates. “There’s no guessing about when the seal is complete, the feedback tells you when the seal is complete. Also, there is a troubleshooting mechanism that tells you if the seal might not be secure, so you can decide to reapply the energy before you pull the trigger to cut the tissue,” he said. Dr. Sands suggests surgeons not comfortable using the LigaSure Impact™ instrument on humans try it out first in a test lab, and Dr. Bristow recommends surgeons gain thorough knowledge of the technology in general. “I think it’s really important to take the time to read the product information and background behind using energy devices as part of surgical procedures to not only appreciate the functionality of the technology, but to also make sure they’re observing

necessary safety precautions, not just for LigaSure™, devices but for energy devices in general,” said Dr. Bristow. Although some institutions move quickly to adopt new technology that holds the promise of increasing efficiency in the OR and improving patient outcomes, many need compelling arguments that a new investment will live up to its purported worth. “In this current, cost-conscious age, you need to present what the benefits are,” Dr. Bruno said. He emphasized the potential cost benefit to his OR committee. With the LigaSure Impact™ instrument, “the patient spends less time under anesthesia and we spend less time in surgery, which results in lower cost because the OR is one of the most expensive places in the hospital. Also, with the secure seal, you’re not concerned that you’ll have someone bleeding after the surgery.” Dr. Bristow did not have to work hard to bring the LigaSure Impact™ instrument into his OR, as his hospital was quick to realize the investment would soon pay off. “This institution is very progressive in recognizing the benefits of vessel-sealing technology, both for improving patient safety and for reducing surgical time … these 2 things ultimately translate into a more favorable bottom line for the hospital.”

References 1. Harrell AG, Kercher KW, Heniford BT. Energy sources in laparoscopy. Sem Laparoscopic Surgery. 2004;22(3):201-209. 2. Targarona EM, Balague C, Marin J, et al. Energy sources for laparoscopic colectomy: a prospective randomized comparison of conventional electrosurgery, bipolar computer-controlled electrosurgery and ultrasonic dissection. Operative outcome and costs analysis. Surg Innov. 2005;12(4):339-344. 3. Marcello PW, Roberts PL, Rusin LC, Holubkov R, Schoetz DJ. Vascular pedicle ligation techniques during laparoscopic colectomy. A prospective randomized trial. Surg Endosc. 2006;20(2):263-269. 4. Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol. 2003;102(1):147-151. 5. Hefni MA, Bhaumik J, El-Toukhy T, et al. Safety and efficacy of using the LigaSure vessel sealing system for securing the pedicles in vaginal hysterectomy: randomised controlled trial. BJOG. 2005;112(3):329-333. 6. Kennedy JS, Stranahan PL, Taylor KD, Chandler JG. High-burststrength, feedback-controlled bipolar vessel sealing. Surg Endosc. 1998;12(6):876-878. 7. Elhao M, Abdallah K, Serag I, El-Laithy M, Agur W. Effiacy of using electrosurgical bipolar vessel sealing during vaginal hysterec-

tomy in patients with different degrees of operative difficulty: a randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2009;147(1):86-90. 8. Silva-Filho AL, Rodrigues Am, Vale de Castro Monteiro M, et al. Randomized study of bipolar vessel sealing system versus conventional suture ligature for vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2009;146(2):200-203. 9. Ding Z, Wable M, Rane A. Use of LigaSure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol. 2005;25(1):49-51. 10. Bruno R, Dick A, El-Sahwi K, Birdsall M, McLellan R. Trial of an advanced bipolar electrosurgical vessel sealer versus traditional ligation techniques in vaginal hysterectomy. J Minim Invasive Gynecol. 2008;15(6 suppl):S1-S159. Abstract 36. 11. Bruno R, Soto-Wright V, El-Sahwi K, Dick, Birdsall M, McLellan R. Evaluation of an advanced bipolar electrosurgical vessel sealer versus conventional ligation technique in abdominal hysterectomy. J Minim Invasive Gynecol. 2008;15(6 suppl):S1-S159. Abstract 231. 12. Campagnacci R, de Sanctic A, Balderelli M, Rimini M, Lezoche G, Guerrieri M. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative study. Surg Endosc. 2007;21(9):1526-1531. 13. Covidien internal testing; 2012 – R0027701_A.

COVIDIEN, COVIDIEN with Logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG.™* Trademark of its respective owner. Other brands are trademarks of a Covidien company. © 2013 Covidien. M121209a 2013/06 Disclaimer: This monograph is designed solely to provide the health care professional with information to assist in his or her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the health care professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. Covidien, the authors, the coordinators, the reviewers, and the McMahon Publishing specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through the reader’s misunderstanding of the content.

SR1126

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