The February 2013 Digital Edition of General Surgery News

GENERALSURGERYNEWS.COM

February 2013 • Volume 40 • Number 2

The Independent Monthly Newspaper for the General Surgeon

Opinion

Program Seeks To Optimize Outcomes by Targeting Risk Factors Before Surgery

Surgery Under the Affordable Care Act: Problems and Possible Solutions

B Y C HRISTINA F RANGOUU

®

Chronic Pain Can Be Limited by Anesthesia Choice Breast Surgery, Thoracotomy Patientss Better Off at Six Months With Local, Regional Anesthesia

B Y H. D AVID R EINES , MD

N

ow that the decision by the U.S. Supreme Court guarantees that the Affordable Care Act (ACA) is indeed the law of the land, it is time to stop ranting, especially in medical journals, and face reality. I don’t listen to Rush Limbaugh or Rachel Maddow, and I don’t believe that ranting helps anyone understand and deal with the problems we face in medicine. This opinion piece is my attempt to discuss a very complex problem with my peers in a manner that I hope will stimulate thoughtful discussion and understanding of an overwhelmingly complex problem.

Last spring, the chief justice of the United States cast the deciding vote on what some have called “Obamacare” (even though the idea of a mandate was a Republican idea originating several years ago with the Heritage Foundation). The law stands despite a poor job of selling the program by the Obama see AFFORDABLE CARE page 33

PROCEDURAL BREAKTHROUGH Clinical Advances of the Endo GIA ATM TM Radial Reload With Tri-Staple Technology in Laparoscopic LAR see page 8

S

urgeons in Washington sttate are targeting surgical compllications by focusing on someth hing often overlooked in quality initiatives: the things th hat patients can do to improove their outcomes in the weeeks and days before they come into the operating room.

Surgeons in the state have launched a new program callled Strong for Surgery. The first largee-scale program to target the preoperative well-being of patients, it is designed to educate health care providers and patients about things patients can do to better prepare themselves for elective surgery.

“Most things we’ve done too improve quality are based on the idea that it’s what we do oncce the patients get into the hospital see STRONG FOR SURGERY page 30

Enteral Contrast Not Beneficial for Suspected Appendicitis, Study Shows CHICAGO—Enteral contrast does not diagnostically benefit patients undergoing appendectomies, according to a study of a majority of patients in Washington state who had this procedure over a two-year period.

As a result of their findings, researchers said that the addition of enteral contrast to IV contrast should

INSIDE EXTENDED HERNIA COVERAGE Pullout Section Page 11

On the Spot

20

Roundtable topics: centers of excellence; component separation; fibrin glue for inguinal hernias

Surgeons’ Lounge

27

The case of refractory strictures and ulcers after gastric bypass; Answers to two Surgeon’s Challenges

not be considered necessary when computed tomography (CT) is performed for suspected appendicitis.

Physicians and hospitals participating in SCOAP (Surgical Care and Outcomes Assessment Program), the voluntary collaborative of surgeons in Washington that led the study, see ENTERAL CONTRAST PAGE 4

B Y D AMIAN M C N AMARA MIAMI BEACH—Administrattion of local or regional anesthesia before some major operations can prevent longterm pain for patients at five to six months postoperatively, according to a recent meta-analysis.

“A large percentage of people have pain at six months, especially after thoracotomy, breast cancer surgery and cesarean section,” Michael H. Andreae, MD, said in an interview at the annual Fall Meeting of the American Society of Regional Anesthesia and Pain Medicine.

Dr. Andreae and his associate, Doerthe A. Andreae, MD, identified 23 double-blind, randomized controlled trials in the literature that compared local or regional anesthesia see POSTOPERATIVE PAIN page 32

PROCEDURAL BREAKTHROUGH Surgical Repair Using Biologic Tissue Matrix To Facilitate Tissue Healing: A Case-Based Report see page 18

COMING IN 2013.

You imagined it.

We made it.

The next advance in HARMONIC® Shears.

For 20 years, EES HARMONIC® Devices have set the standard of surgical practice. And now, we’re setting the standard for the next 20.

Contact your EES Sales Professional to learn more. www.ees.com or 1-800-USE-ENDO

Ethicon Endo-Surgery, Inc. a Johnson & Johnson company ©2013 Ethicon Endo-Surgery, Inc. All Rights Reserved. DSL 12-1370.

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

The ‘Center of Excellence’: Luster or Bluster?

Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

T

here are many terms that are loosely applied in medical jargon. In recent times the term center of excellencee (CoE) has been bandied about so frequently that it has lost meaningful definition even to those who create and espouse them (hospitals, physicians and administrators) and to those who try to make decisions regarding personal health care (patients and caregivers) or health care economics (insurers). Although the concept should be primarily dedicated to providing a level of care not customarily found in surgical units, I assume that an additional goal for establishment of a CoE is an economic or academic advantage in dealing with fellow surgeons or competitor institutions.

In this issue of GSN, N a panel of experts in hernia repair are asked about whether the CoE designation carries meaning in the discipline of herniology (page 20). As one would expect, our panelists opine over a spectrum of views that the CoE concept

should either be embraced because of outside review and standard-setting or jettisoned because of overuse and current nonsignificance of the term. Our experts agree that the CoE is but one model striving to achieve quality benchmarks.

Misgivings may arise from the perception that the designation of a CoE can be exploited as a marketing strategy that smacks of exclusivity and financial advantage and not necessarily one committed to quality. We have certainly witnessed this phenomenon when one hospital system spars with another for patient referrals and insurer exclusivity. My view is that the concept of the CoE is not detrimental or misdirected as long as certain principles are adhered to in its development.

When I think of a model CoE, it conjures up the vision of a team effort, amalgamating the best components of an organization to creatively derive a product that truly is greater than the individual parts. Destructive competitiveness is put aside to create a uniquely exceptional entity that is focused on ideal care of patients having a common malady whether it be abdominal wall hernia, obesity, rectal cancer or breast disease. The CoE

Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC General Surgery, Laparoscopy, Surgical Oncology

Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN General Surgery, Laparoscopy, Surgical Oncology, Ultrasound, Endoscopy

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

Philip S. Barie, MD, MBA New York, NY Critical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPH Norfolk, VA General Surgery, Trauma/Critical Care

David Earle, MD Springfield, MA General Surgery, Laparoscopy

James Forrest Calland, MD Philadelphia, PA General Surgery, Trauma Surgery

Edward Felix, MD Fresno, CA General Surgery, Laparoscopy

Robert J. Fitzgibbons Jr., MD Omaha, NE General Surgery, Laparoscopy, Surgical Oncology

David R. Flum, MD, MPH Seattle, WA General Surgery, Outcomes Research

Michael Goldfarb, MD

Leo A. Gordon, MD Los Angeles, CA General Surgery, Laparoscopy, Surgical Education

Gary Hoffman, MD Los Angeles, CA Colorectal Surgery

Namir Katkhouda, MD Los Angeles, CA Laparoscopy

should always be focused on elevating care of its chosen discipline, not on excluding members or derailing competitors.

The CoE might better approximate this vision by being identified as a “center of competency, quality and proficiency� because competent care of patients is the ultimate goal. Through the generation and promulgation of “standards of competency,� the resultant “quality center� can band with other entities to form a network aimed at seeking accreditation by organizations dedicated to best practices. These networks will ultimately derive standards for surgical evaluation and treatment that will be pervasive and essential to all institutions and practitioners taking care of a specific surgical discipline or disease.

From the patient perspective, everyone desires to have care from physicians and institutions that are “excellent.� A “center of mediocrity� for hernia care would soon be filing for Chapter 11! We would like to think that the care that we provide is excellent in all aspects. If we excel in a particular area of surgical care, we should have a way to differentiate ourselves.

Obviously, the ultimate benchmark that we must use is an outcome measure that

Joseph J. Pietrafitta, MD

Art/MAX Graphics & Production Staff

Minneapolis, MN General Surgery, Laparoscopy, Colon and Rectal Surgery, Laser Surgery

Michele McMahon Velle

David M. Reed, MD

Deanna Cosme

New Canaan, CT General Surgery, Laparoscopy, Medical Technology Development/Assessment

Art Director

Barry A. Salky, MD New York, NY Laparoscopy

Dan Radebaugh Director of Production and Technical Operations

Circulation Coordinator

Change of Address Procedure

McMahon Group Raymond E. McMahon,

Peter K. Kim, MD

Kevin Horty

Bronx, NY Emergency General Surgery

Group Publication Editor (khorty@mcmahonmed.com)

Raymond J. Lanzafame, MD

Associate Editor (msullivan@mcmahonmed.com)

Rochester, NY General Surgery, Laparoscopy, Surgical Oncology, Laser Surgery, New Technology

James Prudden

John Maa, MD

Robin B. Weisberg

San Francisco, CA Surgical Hospitalist

Manager, Editorial Services

Gerald Marks, MD

Associate Copy Chief

Maureen Sullivan

Elizabeth Zhong

J. Barry McKernan, MD

Sales Michael Enright

Marietta, GA Laparoscopy

Joseph B. Petelin, MD Shawnee Mission, KS Laparoscopy

Richard Peterson, MD San Antonio, TX General Surgery, Bariatric Surgery

Publisher & CEO,

Managing Partner

Van Velle, President, Partner Matthew McMahon, General Manager, Partner Lauren Smith, Michael McMahon, Michele McMahon Velle, Rosanne C. McMahon, Partners

Group Editorial Director

Wynnewood, PA Colon and Rectal Surgery, Colonoscopy

Š 2013 by McMahon Publishing, New York, NY 10036. All rights reserved. General Surgery News (ISSN 1099-4122) is published monthly by McMahon Publishing, Sales, Production and Editorial Offices: 545 W. 45th St., 8th Floor, New York, NY 10036, Tel. (212) 957-5300. Corporate Office: 83 Peaceable St. West Redding, CT 06896. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, New York, NY 10036.

Senior Systems Manager

Brandy Wilson

Editorial Staff

mcmahonmed.com

Please send letters to: khorty@mcmahonmed.com.

James O’Neill

Miami, FL Ob/Gyn, Laparoscopy

Youngstown, OH General Surgery, Laparoscopy

Group Publication Director (212) 957-5300, ext. 272 menright@mcmahonmed.com

Kate Carmody Manager of Publication Sales (212) 957-5300, ext. 278 kcarmody@mcmahonmed.com

Alina Dasgupta Classified Advertising (212) 957-5300, ext. 260 adasgupta@mcmahonmed.com

McMahon Publishing is a family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers and nine annual or semiannual Special Editions.

Creative Director

Paul Alan Wetter, MD

Michael Kavic, MD

Long Branch, NJ Laparoscopy, Telemedicine

reflects excellent and competent care and provides a basis for self-evaluation that surgeons can use to help guide their practice and further education.

A “center of quality� ideally would have the goal of improving all aspects of disease management including prevention, identification of early disease, treatment and education. Also, the center should serve an example of first-rate care, and its success should be measured in part by improvement of care throughout the region in many institutions. An advantage of tiered systems such as exist for trauma center designation or commission on cancer accreditation by the American College of Surgeons is that levels of participation appropriate for the institution can be established; a research component, for example, is more appropriate for an academic CoE than a community CoE. Research is a critical component for advancement of care, but does not by itself constitute proficiency.

Whatever we call ourselves, the final product must reflect commitment and a sense of purpose that is difficult to find anywhere else and is inclusive in elevating and the practice of all surgeons involved.

Mission Statement It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

Disclaimer Opinions and statements published in General Surgery Newss are those of the individual author or speaker and do not necessarily represent the views of the editorial advisory board, editorial staff or reporters.

All U.S. general surgeons, colorectal surgeons, vascular surgeons, surgical oncologists and trauma/critical care surgeons should receive General Surgery News free of charge.

If you are changing your address or name, you must notify the AMA at (800) 262-3211 or the AOA (if appropriate) at (800) 621-1773 to continue receiving GSN. You need not be a member; however, they maintain the ultimate source of our mailing addresses.

If you are not a general surgeon or other specialist listed above and would like to subscribe, please send a check payable to General Surgery News. Please allow 8-12 weeks for the first issue. Subscription: $70 per year (outside U.S.A., $90). Single copies, $7 (outside U.S.A., $10).

Send checks and queries to: Circulation Coordinator, General Surgery News, 545 West 45th Street, 8th Floor, New York, NY 10036.

Fax: (212) 664-1242.

INFECTIOUS DISEASE SPECIAL EDITION

3

4

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

ENTERAL CONTRAST jcontinued from page 1

will be encouraged to use CT scans enhanced only by IV contrast material when patients are undergoing evaluation for appendicitis.

“Comparable effectiveness can be achieved using IV contrast alone in CT scans for suspected appendicitis,” said lead author Frederick Thurston Drake, MD, a surgery resident and fellow at the Surgical Outcomes Research Center, ARTICLE BY CHRISTINA FRANGOU

University of Washington, Seattle. He presented the findings at the 2012 American College of Surgeons’ Annual Clinical Congress.

However, surgeons stressed that the study did not take into account the patients who, after receiving the contrast, were diagnosed with pathology other than appendicitis and ultimately did not undergo appendectomy. In other words, the patients who, arguably, derived the greatest benefit from enteral contrast were excluded from the study. “That is a significant weakness,” said Benjamin Braslow, MD, associate professor of

Surgeons stressed that the study did not take into account the patients who, after receiving the contrast, were diagnosed with pathology other than appendicitis and ultimately did not undergo appendectomy.

Critics of using enteral contrast pointed out that it comes with a host of disadvantages: It is time-consuming, unpleasant for patients and may be a risk factor before general anesthesia.

non-narcotic pain relief means

Better outcomes. Satisfied patients.

With the ON-Q* non-narcotic pain relief system, patients: • Went home an average of 1.1 days sooner • Reported up to 69% lower pain scores • Were up to 3x as likely to report high satisfaction scores • Are more likely to experience better pain management with fewer side effects

Every day without out

costs cos you more.

See how ON-Q* can help you. Call your ON-Q* representative today for a complimentary consultation: 1-888-962-4ONQ (4667).

Visit iflo.com today to view our extensive online library of peer-reviewed journal articles, papers, posters and additional clinical trial information.

There are inherent risks in all medical devices. Please refer to the product labeling for Indications, Cautions, Warnings, and Contraindications. Failure to follow the product labeling could directly impact patient safety. Physician is responsible for prescribing and administering medications per instructions provided by the drug manufacturer. Refer to www.myON-Q.com for product safety Technical Bulletins.

I-Flow* LLC, A Kimberly-Clark Health Care Company 20202 Windrow Drive, Lake Forest, California 92630 USA Kimberly-Clark Worldwide, Inc. ©2013 KCWW All rights reserved.

ON-Q* Pain Relief System

*Registered trademark or trademark of

surgery and chief of the emergency surgery service, University of Pennsylvania School of Medicine, Pittsburgh.

However, the authors said that the study was designed to demonstrate realworld results and that earlier, randomized trials demonstrated no benefit in the use of oral contrast (Radiol Technol 2011;82:294-299).

The study was based on data collected

by SCOAP, which represents 60 hospitals in Washington state. Dr. Drake and his colleagues studied consecutive cases of appendicitis at the 58 hospitals that had signed on to SCOAP by the time of the study.

Over a two-year period, 9,047 patients underwent nonelective appendectomy, representing 85% of nonelective appendectomies performed in the state at that time. In the study group, 89% of patients had a CT scan before surgery. Almost half (52%) of the patients received IV contrast before the CT, whereas 27% had IV contrast and some form of enteral contrast. In almost all cases where patients received enteral contrast (97%), the contrast was administered orally. A minority of patients received no type of contrast or enteral contrast alone. Concordance between radiology and pathology was approximately 90%, regardless of contrast regimen.

Analysis showed that patients who received enteral contrast rather than IV contrast alone had slightly higher rates of perforations (17.4% vs. 14.7%, respectively; P P=0.005), higher rates of negative appendectomy (3.5% vs. 2.7%; P=0.046), P and longer duration between their admission to the emergency department and

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

improved diagnostic accuracy. But many of those studies relied on early generation scanners, said Dr. Drake. With today’s 64-multidetector helical scanners, more recent studies suggest the oral contrast is not of added benefit (Radiol Technoll 2011;82:294-299).

However, Dr. Braslow said that the SCOAP study is not sufficient to convince him to cease the use of enteral contrast. “Using IV contrast alone is an interesting concept that has been discussed for a long time. There is a lot of information missing in this study, [for instance] the patients who did not

the beginning of surgery, waiting an average of 9.1 hours compared with 8.3 hours (P<0.001). The authors said that they do not believe the type of contrast administered led to any differences in the rate of perforations.

Currently, no clear standard exists on the use of enteral contrast before an abdominal-pelvic CT scan in cases of suspected appendicitis. Critics pointed out that enteral contrast comes with a host of disadvantages: It is time-consuming, unpleasant for patients and may be a risk factor before general anesthesia. Moreover, in as many as one-third of patients, the enteral contrast fails to reach the cecum.

Conversely, proponents argue that enteral contrast can help identify the appendix, or any other pathology. “I don’t think that PO [positive oral] contrast is always necessary to make the diagnosis of an acute appendicitis but, if you’re wrong about the diagnosis, especially in female patients where there is other potential pathology in the region, the presence of PO contrast gives you important information,” Dr. Braslow said.

The study was not powered to show that enteral contrast led to higher rates of perforations, negative appendectomies or long waits before surgery. However, investigators said that the study failed to show a single benefit for enteral contrast over IV contrast alone and that, along with their findings, recent randomized trials in radiology literature suggest “comparable effectiveness.” They also pointed out that patients were not randomized to one contrast type or another, potentially introducing selection bias, and final radiology reports were used to determine concordance.

Earlier studies supported the use of enteral contrast, showing that it led to

undergo appendectomy and the time from a [patient’s admission to] the emergency room to having a CT scan. We need these things explained.”

He added that emergency doctors often make the call on the type of contrast used for a patient with suspected appendicitis.

The study showed that hospital characteristics did not influence the use of enteral contrast. Rates were similar across urban and rural hospitals, and for hospitals with and without surgical residency programs.

Hospitals that participated in SCOAP

were not required to stop the use of enteral contrast as a standard for patients with suspected appendicitis. Avoiding enteral contrast, however, will be set as a “best practice” benchmark across SCOAP hospitals. Surgeons, emergency room doctors and radiologists will receive quarterly reports that track the use of enteral contrast and monitor changes in practice.

“Ultimately, we’ll be tracking quarterby-quarter use of enteral contrast, and concordance, to make sure we’re improving. This is how we cut the translation of evidence into practice from years to months,” Dr. Drake said.

surgeon preferred anatomical coverage and conformance…

a new dimension in laparoscopic hernia repair.

Find out more about Atrium’s C-QUR CentriFX™ hernia repair solutions at

www.atriummed.com/c-qur Atrium is now part of MAQUET GETINGE GROUP © Atrium Medical Corporation 2013. All rights reserved. Atrium and C-QUR CentriFX are trademarks of Atrium Medical Corporation, a MAQUET GETINGE GROUP company.

5

6

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

Women Surgeons Call to Mind Their 100-Year History B Y C HRISTINA F RANGOU CHICAGO—This year marks 100 years since the first women on record were admitted to the American College of Surgeons (ACS).

To honor the anniversary, General Surgery Newss interviewed Maria Georgiou Ikossi, MD, and Danagra Georgia Ikossi, MD, a mother and daughter pair, both of whom are general surgeons and fellows of the American College of Surgeons.

They are one of few—and perhaps the only—mother–daughter duos among the fellows of the ACS. The ACS doesn’t track these statistics, but no one within or outside of the ACS was able to identify any other mother–daughter pairings in the organization.

Dr. Maria Ikossi was admitted to the ACS in 1978, her daughter in 2011.

Together, they tell an illuminating story about how surgery has changed from generation to generation.

Dr. Maria Ikossi was born on the island of Cyprus in 1945 to a family of lace makers. At the age of 5, she announced, while dissecting a lamb heart in the family kitchen, that she would become a surgeon. It was an atypical ambition for a young girl in the 1950s, particularly one whose family had no ties to medicine or science.

She pursued her education with fervor (as did her four sisters who became a nuclear physicist, an electrical engineer, an archeologist and a mathematician).

When Maria was 17, she flew to Minnesota, where she completed her undergraduate degree, and went on to medical school at Washington University in St. Louis followed by a surgical residency at Boston University.

At that time, women represented less than 4% of every medical school class in the United States or Canada. And their numbers in surgery were even less. The ACS admitted no more than five women per year until 1975, making up less than 2% of the classes.

“The proportion of women in medical school in the United States was very small,” said Dr. Maria Ikossi. “And of those, of course, the proportion going into general surgery was very, very small.

And the real question is, how many made it through the training program at that time, because it wasn’t well accepted.

“Residency was difficult in that they were expecting you to fail. At the time, or even 10 to 15 years later, you would be pushed aside. A woman would not be given the better cases. There was not a fair distribution of the work. You would end up with more scut work than the boys. It took a little doing. At that time,

Mother and daughter duo, Maria Georgiou Ikossi, MD (left), and Danagra Georgia Ikossi, MD, attend the daughter’s induction as a Fellow of the American College of Surgeons in 2011. Both mother and daughter are general surgeons and fellows of the College.

it was a brutal kind of thing to do surgical training. The thinking was to abuse people, both male and female, but females got abused a little bit more.”

Dr. Ikossi lacked female mentors and female colleagues as she went through training. “Nearly all of the professors were male and they always assumed that a woman was not going to do anything with surgery. I had one person along the way who decided that he was going to disregard the sex and he happened to be in a position of power. His support and mentorship were invaluable to my completing the program.”

During residency, Dr. Ikossi took an interest in surgical oncology, then a virtually “nonexistent field.” She pursued additional training over the next few years: a

surgical oncology fellowship and a PhD in experimental pathology at Roswell Park Memorial and a fellowship in thoracic surgical oncology at the University of Texas MD Anderson Cancer Center, Houston. After a brief tenure in academic medicine, she moved to Maine and now practices thoracic and general surgical oncology in a hospital-affiliated practice.

It was during her PhD research years that she gave birth to her daughter Danagra, now a minimally invasive surgeon in San Jose with three children of her own.

Dr. Danagra Ikossi remembers a childhood centered at the hospital. “We didn’t go anywhere on the weekends before we did rounds at both hospitals first. And from a very young age, I could estimate how long it was really going to take—not

how long she said it was going to take— by the number of patients in the ICU and the number of patients on the floor.”

There were trade-offs to being the daughter of the town’s oncologic surgeon, said Dr. Danagra Ikossi. She endured more than one long wait at the bus stop while her mother was held up in hospital. Stamped more clearly on her memory, however, is the way the people in the town responded to her mother.

“We would go to the supermarket together, however infrequently, and these petite French-Canadian ladies from Maine would run down the supermarket aisle and throw their arms around her and say to their friends, ‘this is my surgeon. This is the one who saved my life.’

No amount of waiting at a bus stop will undo the good that that does. It made a really strong impression on me.”

Dr. Danagra Ikossi said her mother, knowingly or not, fulfilled the role model position for her daughter that she herself had lacked. “She has a passion for the field and a passion for what she does that is infectious. You can’t escape it.”

Dr. Danagra Ikossi’s own medical school and residency program experiences differed greatly from those of her mother’s. Gender, she says, was not an issue. When Dr. Danagra Ikossi started residency at Stanford University in 2001, four of the five general surgery residents were women and Myriam J. Curet, MD, was the assistant program director.

Both male and female attendings treated the residents equally, regardless of gender. “The mentorship I received was not only from women attendings but also from the male attendings who treated me equally, saw my strengths and weaknesses and invested time and energy into training me.”

One of the more marked differences the two women found in their careers is the much more supportive attitude that exists today toward women who choose to have children and still pursue their profession.

“The good thing now about the young generation is [Danagra] was able to have a life outside of medicine without having to apologize for it or hide it,” said the elder Dr. Ikossi. “She was able to have the children she wanted to have. When I was starting, that was extremely difficult.

There were a few female residents along the way but many of them didn’t last very long. The idea was that you could not be in medicine and be a wife and a mother and have some kind of a life.”

Dr. Danagra Ikossi pointed out that, today, she is surrounded by close female friends who also are surgeons—something that was not true of her mother’s generation. That camaraderie makes it easier for her to discuss concerns and

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

experiences in ways she wouldn’t with male colleagues.

“The way we communicate is so different. I can’t call my male colleagues up and say, ‘oh, I wish I’d done this or I wish I’d done that,’ ‘it should have been like this or it should have been like that.’

Women can talk to each other that way and understand that it is not insecurity. That’s not weakness. That is a way we can express ourselves and emote and bounce things off of each other.”

Dr. Danagra Ikossi said that women bring a different style of communication into the operating room, an observation

‘Residency was difficult in that they were expecting you to fail. At the time, or even 10 to 15 years later, you would be pushed aside. A woman would not be given the better cases.

—Maria Ikossi, MD

Download the free App

1

Market information on your iPad including procedural videos

2 3

View the content of each monthly issue

4

Use the editorial content as a discussion point with your clients s

5

Reference your branded medical education (Special Reports, Procedural Breakthroughs)

6

The GSN archive of clinical data is at your fingers

Share the dialogue with your field force as a resource for education

that’s been well documented in fields outside of surgery. Research led by sociolinguist Deborah Tannen has shown that, broadly speaking, women leaders tend to use modifiers, ask more questions, give orders in a less direct manner and are more willing to level out a hierarchy within a room.

The field of surgery has benefited from this communication style, said Dr. Danagra Ikossi. “It’s helped make it more open. It works very well in education, in particular. When you’re teaching, you’ll talk something through, explaining everything you are doing and thinking.

You’ll say ‘here is what I’m looking at, here is what I’m thinking about, this is what you might want to consider and this is what might go wrong and this is how I’m going to try to prevent that.’”

The Ikossi story shows how different the landscape was for women who joined the surgical profession in the 1960s compared with today, said Barbara Bass, MD, the John F. and Carolyn Bookout Distinguished Endowed Chair of Surgery at The Methodist Hospital, in Houston.

“Women surgeons were few and far between, and each was making a new path—in training, choosing a discipline, forming professional bonds, and making a home and family without a model to guide them. I am always amazed at the creativity and determination in the stories of the women surgeons of this time. They (and I’m afraid I, too, am old enough to qualify) were so visible that our actions were highly scrutinized sometimes with an eye that looked for flaws.”

“We all benefited from the guidance of the very few women surgeons that we could find who had run the gauntlet in their own way, and we all were guided and taught by many men in our profession who nurtured us and recognized then and now that gender is not a defining quality of a surgeon.”

Today, Dr. Maria Ikossi works in a busy private practice at St. Mary’s Surgical Associates in Lewiston, Maine, where she specializes in thoracic and oncologic surgery. Dr. Danagra Ikossi is a minimally invasive general surgeon with the San Jose Medical Group, and is an educator for the VA/Stanford Minimally Invasive Surgery Fellowship and the O’Connor Hospital Family Medicine Residency.

DID YOU KNOW? In 1960, women represented less than 4% of every medical school class in the United States or Canada. Today, that number is 50%.

The American College of Surgeons admitted no more than five women per year until 1975, making up less than 2% of classes.

In 2010, 2011 and 2012, the percentage of active ACS female members: 10.6%, 11% and 11.6%, respectively.

7

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Clinical Advances of the Endo GIA™ Radial Reload With Tri-Staple™ Technology in Laparoscopic LAR Conor P. Delaney, MD Division Chief, University Hospitals Professor of Colorectal Surgery Case Medical Center Cleveland, Ohio

Linda M. Farkas, MD Co-Chief, Colorectal Surgery Associate Professor of Surgery Duke University Raleigh-Durham, North Carolina

Introduction Lower anterior resection (LAR), a procedure commonly performed in the treatment of rectal cancer and diverticulitis, is generally preferable to an abdominoperineal resection (APR) in terms of preserving the sphincter and retaining normal bowel function. The overall quality of life has been shown to be similar in patients undergoing both types of resections. However, there are differences among specific emotional and physical domains of quality of life with each surgical approach. With this knowledge, surgeons can work toward individualizing their surgical approach to the needs of each patient.1 “Some patients handle having a bag very well, but other people are affected emotionally by having a colostomy bag. For those patients, that can be very limiting for their quality of life,” said Linda M. Farkas, MD, colorectal surgeon and associate professor of surgery at Duke University in Raleigh-Durham, North Carolina. Dr. Farkas performs anorectal and abdominal procedures and tends toward laparoscopy or robotic surgery for abdominal procedures.

The ability for surgeons to perform LAR arose in part due to the pioneering vision of Mark M. Ravitch, MD, who observed surgeons using staplers for pulmonary procedures while traveling in Russia during the late 1950s.2 “It’s because of these staplers that fewer patients get APRs now and we are able to perform LARs,” Dr. Farkas said. “If the patient can still get a good oncologic resection as an LAR as opposed to an APR, this gives the patient the best opportunity to avoid having a permanent colostomy.”

Laparoscopic and even open LAR can be fairly challenging,3 as the narrow structure of the pelvis can both hinder maneuverability and decrease visibility.4 To address the challenges faced by surgeons performing laparoscopic LAR, Covidien has developed the Endo GIA™ Radial Reload, the latest of the company’s staplers with Tri-Staple™ technology, and the newest instrument in the company’s portfolio of colorectal surgical devices. The Endo GIA™ Radial Reload’s curved shape and narrow profile are designed to allow better access, greater maneuverability, and enhanced visibility, while the Tri-Staple™ technology, with its progressive staple heights and stepped cartridge face, ensures a secure staple line. The Endo GIA™ Radial Reload can accommodate a wide range of tissue thicknesses, can rotate 360 degrees, is compatible with

8

GENERAL SURGERY NEWS • FEBRUARY 2013

all Covidien universal handles, and can achieve depths up to 2 cm lower than competitive staplers (Figure 1).5

Clinical Experience “Most surgeons perform LAR by dividing the rectum with a stapling device designed for that procedure, removing the diseased portion, then bringing a healthy piece of colon down and attaching it to the distal healthy rectum,” said Conor P. Delaney, MD, division chief of University Hospitals and professor of colorectal surgery at Case Medical Center in Cleveland, Ohio. “For laparoscopic LAR, we use staplers that we can put in through a 12 mm port and angulate perpendicularly across the rectum, [therefore] they seal both ends and divide it,” said Dr. Delaney.

Maneuvering the stapler across the rectum can be challenging because the pelvis is a fairly narrow structure with bone on either side, Dr. Delaney explained. “It’s like operating in a cylinder and trying to take out something that almost completely fills that cylinder. You have very little room to get the staple down beside the rectum in order to divide it.”

Dr. Farkas finds the distal transection of the rectum is

the most challenging part of the procedure, partly due to the design of most staplers. “Most of the staplers we have now don’t angulate well enough to go transversely across the rectum in 1 bite, or to reach as far as necessary into the pelvis, especially in men, as men have narrower pelvises than women” she said.

“This is a curved stapler,” said Dr. Delaney, “but it has the same principal as all laparoscopic staplers, with 3 rows of staples proximally and 3 rows distally, and a blade that cuts in between.”

Dr. Delaney has used the Radial Reload in 15 to 20 laparoscopic LAR cases since it became available and appreciates the narrow profile and the unique tissue retention feature that allows him to achieve complete division across the rectum in a single firing. “There is a special tab at the end of the stapler that keeps the rectum fitted in the stapler so that it gets transected by the blade,” he said. “That’s important because with the [previous] laparoscopic stapler[s], part of the rectum would get extruded out of the distal end of the stapler as you closed it. In that case, you would need another stapler cartridge. But this design allows you to more routinely divide the rectum with a single staple load.”

Progressive staple heights, unique q tapered p cartridge g face

Staples and transects tissue

Unique tissue retention feature

Narrow profile

360 degree rotation

Compatible with all Endo GIA™ Universal, Endo GIA™ and Ultra Universal handles

Figure 1. Endo GIA™ Radial Reload with Tri-Staple™ Technology.

Data on file. Covidien.

Operates in both Coronal and sagittal planes

Supported by

B

C

D

Figure 2. Performing a laparoscopic LAR with the Endo GIA™ Radial Reload with Tri-Staple™ Technology.

(A) Dr. Delaney horseshoeing the Radial Reload through an existing extraction site.

(B) When he extracts the intestine for laparaoscopic cases using a wound protector he enters through a 15 mm port with the Radial Reload already backloaded.

(C) He finds the Radial Reload easy to maneuver laparoscopically and easier to reach the intestine from the left when dividing the bowel as opposed to the traditional right side.

(D) He finds the biggest advantage is that he needs only one cartridge to divide the intestine and the helpful nature of the tissue retention feature.

Increased Visualization Visualization is one of the great challenges to LAR, given the limited space within which surgeons are working.

Dr. Farkas finds that using the Radial Reload enhances visualization in 2 ways.

“With the [previous staplers] used in [my] cases, the width of the head of the stapler was much larger, so sometimes it was harder to engage it adequately distal to the tumor,” she said. The fact that the Radial Reload is narrow is helpful, but the biggest difference is that, because she can introduce the Radial Reload without making a counter incision, she can avoid converting to an open LAR. “Laparoscopic surgery gives you better visualization,” Dr. Farkas said. “If you can perform a distal transection laparoscopically, that’s a great aid, [and] the Radial Reload allows me to complete more of my cases laparoscopically.”

Improved Accessibility Dr. Farkas finds that she can get as low as she needs to in the pelvis using the Radial Reload. She recalled a recent case in which she would have had to convert to open LAR if she had not been using the new technology. “We had a case where we were able to get about 1 cm above the dentate line. This would have been nearly impossible with [other staplers]; it would probably have required making a pfannenstiel incision on this [female patient],” she said. “The Radial Reload helped me get much lower and maintain a laparoscopic approach.”

Oncologic outcomes appear to be similar in laparoscopic and open LAR6,7 and the laparoscopic approach benefits the patient in a multitude of ways. “Laparoscopic colon surgery has been shown to allow patients to resume a diet faster, be discharged from the hospital faster, and to have less pain,” Dr. Farkas said. “The long-term benefits, 2 to 3 weeks down the road, are great for laparoscopic patients.” Patients

Improved Maneuverability

Dr. Farkas finds that the curved shape of the Radial Reload allows her to place the stapler transversely across the rectum rather than having to angulate the instrument into place. “[Other staplers] don’t come across the rectum at a nice 90-degree angle because they can’t articulate that much. You’re always approaching the rectum at an angle and trying to retract the rectum to counteract that angle from the stapler,” she said.

“With the Radial Reload you don’t have to do that.”

Dr. Farkas typically approaches tissue from the sagittal plane, but appreciates being able to approach from the coronal plane when necessary, which the design of the Radial Reload allows her to do. “The sagittal seems to work better on a higher transection for me, although with very low transections, the coronal approach works better,” she said. This was not an option with other staplers “because the heads were too big to give both approaches as an option.”

“Pelvises are very unique; not every person has the same size or same shaped pelvis. The ability to maneuver the stapler in various planes to compensate for the variability of the pelvic shape and size, and height of transection is an advantage of the Radial Reload,” Dr. Farkas said. Both surgeons find that single firing gives them a strong, secure staple line. “It’s a nice, solid firing of a nice, solid staple,” Dr. Delaney said.

“I’ve had concerns about staple-line security, especially being in a teaching institution and having the residents introduce the stapler up through the anus to the staple line—I’ve seen staple lines unzip a bit if too much pressure is placed against them,” Dr. Farkas said. “With 3 rows of staples [in Tri-Staple Technology], the Radial Reload has a very secure staple line. I haven’t seen any unzip.”

Ease of Use The shape of the new instrument, although meant to ease maneuverability once inside the abdominal cavity, can present a challenge in the initial access. Instrumental ports

are straight; the Radial Reload is curved. Dr. Delaney removes the port and slides the port over the stapler handle before attaching the stapler cartridge. “The stapler is then passed into the abdomen through the abdominal wall before siding the port down into place in the abdominal wall.” Dr. Farkas finds she usually has to widen the 12 mm port slightly. “Then I horseshoe the head of the stapler in prior to re-engaging the shaft to the staple head,” she said (Figure 2).

She recommends that surgeons new to or skeptical of the Radial Reload try it a couple of times on open procedures to get a feel for the instrument, and then use it on simpler laparoscopic cases. “They’ll probably have great benefits using it low on the rectum, [but should start] using it up on the mid- to upper rectum.” Dr. Delaney, too, recommends using the Radial Reload first on simpler cases, such as patients with wider pelvises, who are not obese and whose cancers are not too low, to get familiar with the instrument before moving on to more difficult cases.

Conclusion The Radial Reload allows surgeons the ability to complete a case laparoscopically and achieves greater ease in accessing the tissue they need to resect. “It gives you a much better chance to use 1 staple load rather than 2 or 3 or 4, and allows you to get much lower in the rectum if that is what is needed,” Dr. Farkas said. She anticipates use of the Radial Reload will ease her future laparoscopic LARs. Dr Farkas also noted, “it will definitely decrease the reasons I would need to make a counter incision to complete a transection, which has probably been the number 1 reason I’ve had to convert from laparoscopic to open.” The Radial Reload “more easily allows you to divide the rectum with 1 firing of the stapler,” Dr. Delaney said. He also suspects that being able to divide the rectum with only 1 cartridge has the potential to reduce the cost of the procedure in terms of equipment.

References 1. Cornish JA, Tilney HS, Heriot AG, Lavery IC, Fazio VW, Tekkis PP. A metaanalysis of quality of life for abdominoperineal excision of rectum versus anterior resection for rectal cancer. Ann Surg Oncol. 2007;14(7):2056-2068.

2. Naef AP. The mid-century revolution in thoracic and cardiovascular surgery: part 3. Interact Cardiovasc Thorac Surg. 2004;3(1):3-10.

3. Brannigan AE, De Buck S, Suetens P, Penninckx F, D’Hoore A. Intracorporeal rectal stapling following laparoscopic total mesorectal excision. Surg Endosc. 2006;20(6):952-955.

4. Zmora O, Wexner SD. Part I–Laparoscopic surgery for colon and rectal cancer. Curr Probl Cancer. 2001;25(5)286-309.

5. Covidien. Date on file.

6. Fellciotti F, Guerrieri M, Paganini AM, et al. Long-term results of laparoscopic versus open resections for rectal cancer in 124 unselected patients. Surg Endosc. 2003;17(10):1530-1535.

7. Pugliese R, Di Lerna S, Sansonna F, et al. Results of laparoscopic anterior resection for rectal adenocarcinoma: a retrospective analysis of 157 cases. Am J Surg. 2008;195(2):233-238.

8. Veldkamp R, Kuhry E, Hop WC, et al. Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial.

Lancet Oncol. 2005;6(7):477-484.

9. Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004;350(20):2050-2059.

10. Schwenk W, Haase O, Neudecker J, Muller JM. Short term benefits for laparoscopic colorectal resection. Cochrane Database Syst Rev. 2005;(3):CD003145.

11. Nandakumar G, Cleshman JW. Laparoscopy for rectal cancer. Surg Oncol Clin N Am. 2012;19(4):793-802.

12. Jayne DG, Guillou P, Thorpe H, et al; UK MRC CLASSIC Trial Group.

Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASSIC Trial Group. J Clin Oncol.

2007;25(21):3061-3068.

GENERAL SURGERY NEWS • FEBRUARY 2013

9

BB129

A

receiving LAR have been shown to tolerate fluids sooner, use less analgesics in the days immediately following surgery, have earlier first bowel movements, and spend fewer days in the hospital.8-10 Dr. Farkas feels that the ability to access tissues low in the rectum with the Radial Reload helps her achieve better distal margins.

“Ultimately, whether you perform an operation with standard open technique or with minimally invasive technique, you need to do a good cancer operation. This means good margins proximally, circumferentially, and distally.

If you’re doing LAR for cancer, avoiding a positive margin is of the utmost importance to reduce the risk for local recurrence and [to increase] survival,” she said.

However, as Dr. Farkas notes, treating cancer with laparoscopic LAR is undergoing further investigation but “preliminary studies have shown equivalent oncologic results.”11,12

NOT ANYMORE. The Covidien ProGrip™ composite mesh for hernia repair is a self-gripping technology that potentially eliminates the need for fixation of any kind.

The result? Patients experience less post-operative pain than conventional fixation-based repair, according to a recent clinical trial. It’s just one example of how Covidien is collaborating with healthcare professionals to solve medical issues to help improve patient care and safety.

At Covidien, we’re not just committed to medical innovation — we’re committed to making a difference in patients’ lives. See how at covidien.com/innovation

COVIDIEN, COVIDIEN with logo, Covidien logo, and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. © 2012 Covidien.

EXTENDED HERNIA COVERAGE Bioabsorbable Mesh Produces Good Early Results for Complex Ventral Hernias COBRA Trial Has ‘Very Provocative’ Preliminary nary Outcomes, but Long-Term Still Unclear B Y C HRISTINA F RANGOU CHICAGO—Interim results from a prospective multicenter study demonstrate that use of a bioabsorbable mesh in complex ventral hernia repair results in favorable early outcomes with a hernia recurrence of 4% and a wound infection of 22% after a mean follow-up of nine months.

If the results hold up in the long term, the findings could change the way contaminated complex ventral hernias are approached by making repair possible with a bioabsorbable synthetic mesh. However, it’s too early to know from this industry-sponsored trial if bioabsorbable synthetic meshes do have a future in these repairs, said experts.

“The bioabsorbable mesh is a synthetic mesh and can be a nidus for microorganisms. Long-term results are going to be very important but the preliminary results are very encouraging,” said Kamal Itani, MD, professor of surgery at Boston University School of Medicine and chief of surgery for the VA Boston Health System, after reviewing the study.

The COBRA (Complex Open Bioabsorbable Reconstruction of the Abdominal Wall) trial is the first large study to focus on bioabsorbable synthetic meshes in complex ventral hernia repairs.

Biologic meshes are typically used in these

12

Open Hernia Repair With General Anesthesia Found Less Safe in Study.

14

Society Launches Initiative to Imrove Quality, Value of Hernia Repair

accurately predict which patients are likely to have a successful fascial reapproximation. In cases where reapproximation appears unlikely, they may not pursue surgery, he said.

“This is an issue that we all deal with as general surgeons when faced with a patient with a complex hernia. Should we should be offering these patients surgery for non-incarcerated hernias, in light of all the economic costs that are incurred when we fix these complex hernias with marginal results?” said Dr. Bhanot, MD, assistant professor of surgery at Georgetown University School of Medicine and director of the MedStar Georgetown University Hospital Comprehensive Hernia Center, Washington, D.C.

20

On the Spot: Experts debate controversial issues in the ”2013 Art of Herniology” rountable

PROCEDURAL BREAKTHROUGH Surgical Repair Using Biologic Tissue Matrix To Facilitate Tissue Healing: A Case-Based Report see page 18

see FASCIAL APPROXIMATION page 12

see PRESIDENTIAL ADDRESS page 15

Surgeons Consider Not Operating When Likelihood of Success Is Low

CHICAGO—Surgeons from Georgetown University Hospital are using preoperative computed tomography (CT) scans to help predict which patients can successfully undergo midline fascial approximation with component separation.

The team, led by surgeon Parag Bhanot, MD, has developed a novel approach to the preoperative CT work-up. They use axial and sagittal measurements from CT scans to calculate the transverse defect size, the defect area and the percentage of abdominal wall taken up by the defect.

Based on the results of these measurements, the team says they can more

Learning Together and roving Care he 15th Annual Meeeting of the Americas H Hernia Society will be held d in Orlando, Fla., and folllows the first worldwide meeting of hernia surgeeons and societies held lasst year in New York City. N Now that the hernia surgeon world has fi finally been brought together, it is timee to learn how we can open our organiization to many other stakeholders in hernia disease, including the m most important stakeholder, th he patient, and how we can contin nue to learn from each other and h how to improve the value of herniaa care.

You m might notice the organization has modified d its name to reflect the original intent that this hernia society would represent all a of the Americas, not just the United d States or North America.

With Sergioo Roll, from Brazil, presiding as president id of this meeting, the society is demonstrating that we truly do represent all of the Americas.

The meeting in Orlando will continue to offer current science applied to hernia disease; basic science work and applied clinical results will be presented by invited speakers and surgeons who have submitted abstracts for oral, poster and video presentations. Although this is not a joint meeting, there will still be representation from many other parts of the world, a continued demonstration that we are now all connected globally.

In addition to surgeons presenting, there will be several other stakeholders making presentations, particularly in the session titled The Patient Matters. In this session, we will hear about some of the emerging efforts in health care to allow the patient to play a more active role in his or her care. A description of a new role for a patient care manager to provide care coordination and

Surgeons eons Use CT Scans To Predict Success of Midline Fascial Approximation B Y C HRISTINA F RANGOU

Presidential Address

B Y B RUCE R AMSHAW , MD

see COBRA page 16

IN THIS ISSUE

February 2013

12

Extended Hernia Coverage

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

Open Hernia Repair With General Anesthesia Found Less Safe in Study B Y C HRISTINA F RANGOU CHICAGO—In a study that looked at “real-world” outcomes after inguinal hernia repair in the United States, laparoscopic surgery and open surgery with local anesthesia were protective against both minor and major complications.

“Compared to an open approach with general anesthesia, inguinal hernia repair done with a laparoscopic approach or an open approach with local anesthesia have superior safety, even after controlling for patient characteristics,” said lead author Aaron S. Rickles, MD, general surgery resident and research fellow at the University of Rochester Surgical Health Outcomes & Research Enterprise (SHORE).

Dr. Rickles presented the findings at the 2012 Clinical Congress of the American College of Surgeons (ACS).

The study relies on administrative data, which limits the strength of the findings. Even so, it is the first large “real-world” report to demonstrate that laparoscopic inguinal hernia repair is superior to open repair with general anesthesia. The latter is the most commonly performed type of repair in this country.

Earlier randomized controlled trials have shown that the laparoscopic approach is associated with an increased risk for intra-abdominal injury, although it has the benefit of reduced postoperative pain and shorter recovery time (Cochrane Database Syst Rev v 2003;1:CD001785; N Engl J Med 2004;350:1819-1827). But those early studies were conducted when laparoscopic surgery was still new and surgeons were less experienced with minimally invasive surgery.

The researchers studied data collected by the National Surgical Quality Improvement Program (NSQIP) between 2005 and 2010. During that period, 71,126 inguinal hernia repairs were performed. Most of them, 58.3%, were done as open repairs with general anesthesia.

Laparoscopic repairs and open repairs under local anesthesia accounted for 21.8% and 19.95%, respectively.

FASCIAL APPROXIMATION jContinued from page 11

At the 2012 Clinical Congress of the American College of Surgeons, Dr. Bhanot presented a retrospective review of 54 patients (22 men and 32 women) who underwent enhanced preoperative CT scans followed by component separation for hernia repair between 2007 and 2011. Forty-eight patients underwent successful fascial closure and six required a bridged repair.

Mean body mass index (BMI) and age were similar in the two groups.

The investigators used logistic regression analysis to identify individual patient characteristics or CT characteristics that could predict the likelihood a patient could undergo a successful fascial closure. Only three factors were significant: transverse defect diameter, defect area, and percentage of the abdominal wall taken up by the defect. Age, gender, weight, BMI and the vertical size of the defect had no bearing on fascial reapproximation.

Michael Rosen, MD, chief of GI and general surgery and director of the Case Comprehensive Hernia Center at Case Western Reserve University, Cleveland, said that the study addresses “a very important concept.” By

Multivariate analysis showed that laparoscopic surgery was associated with significantly reduced rates of minor and major complications compared with open repairs. Laparoscopic repairs reduced the risk for major complications by about 20%, with an odds ratio (OR) of 0.801 (95% confidence interval [CI], 0.659-0.974).

Despite this finding, investigators did not detect any difference in the safety profile between laparoscopic repair and open repair with local anesthesia.

“We found no statistically significant difference in risk of minor or major complications between a laparoscopic approach and an open approach with local anesthesia,” said Dr. Rickles.

Surgeons, including those affiliated with the study, noted that the study has considerable weaknesses. It is an observational study, not a randomized trial, so cause and effect cannot be definitively established. Investigators used administrative data that may contain inaccuracies or inconsistencies, and the hospital mix in ; NSQIP, although varied, may overrepresent academic hospitals at 58%.

Table. Risks for Complications in Study Risk Factor

Odds Ratio (95% CI)

Laparoscopic approach

0.801 (0.659-0.974)

Age >65 y

1.418 (1.206-1.666)

ASA class >2

1.895 (1.579-2.273)

Renal insufficiency

2.422 (1.633-3.593)

Dependent functional status

3.071 (2.330-4.041)

Hepatic insufficiency

3.577 (2.329-5.494)

Emergent surgery

3.393 (2.684- 4.289)

Guy R. Voeller, MD, professor of surgery, University of Tennessee Health Sciences Center, in Memphis, said that the study has problems common in the inguinal hernia literature.

“We don’t know the experience of surgeons in the laparoscopic repair, we don’t know how many they do a year [or] the types of open repair. There are so many variables in here that I think you will find many open hernia surgeons who would disagree vehemently with the conclusions.”

“It’s interesting to see that laparoscopic inguinal hernia [repair] was superior to open repair with general anesthesia,” said Dr. Voeller. “But based on this, I would conclude that an open repair with local anesthesia is the best repair because it reduces the risk of both minor and major complications and [is] without the risks of general anesthesia.”

It is important to put the study findings in perspective. The operative approach, although important, was not as predictive as patient demographics with regard to complications. Factors such as age older than 65 years (OR, 1.418; 95% CI, 1.206-1.666), having an American Society of Anesthesiologists (ASA) class greater than 2 (OR, 1.895; 95% CI, 1.579-2.273), renal insufficiency (OR, 2.422; 95% CI, 1.633-3.593), dependent functional status (OR, 3.071; 95% CI, 2.330-4.041) and hepatic insufficiency (OR, 3.577; 95% CI, 2.329-5.494) all presented greater risk for complications. Consistent with other studies, patients undergoing emergent surgery faced a significantly increased risk for complications, with an odds ratio of 3.393 (95% CI, 2.684-4.289) (Table).

Still, the operative approach is important because it is a variable that surgeons can control, said Dr. Rickles.

“Patient characteristics like ASA score, hepatic insufficiency, renal insufficiency, we can’t really change. But this is something we as surgeons can do differently to improve the outcomes of patients.”

ASA, American Society of Anesthesiologists; CI, confidence interval

trying to predict outcomes for fascial reapproximation, patients could be counseled accordingly. However, the study is very preliminary and includes too few patients to have real, clinical implications, he said. “This idea of reasonable expectation setting for patients is so important. This is a great first step in that direction but we need to look at it in a much larger series.”

Dr. Rosen added that he would not withhold reconstructive surgery based solely on a patient’s CT results.

“It’s still worth giving it an attempt in the OR [operating room] for a patient who might be able to be reconstructed. A bridged repair, especially with synthetic mesh, is not always a failure. It’s still an improvement in quality of life.”

The investigators could not establish absolute cutoff values for the CT measures. However, they reported when the defect represented 20% or more of the circumference, it was likely to result in a bridging repair.

Patients who had successful reapproximation had a defect size of about 10% of the circumference. The mean transverse defect size in the reapproximation group was 10.4 cm compared with 19.8 in the bridged groups. The respective defect areas were 184.2 cm2 and 420 cm2.

Dr. Bhanot and colleagues now measure these variables in all patients with a complex hernia. “If I do not think there’s a reasonable chance that even with component separation that I can get their midline approximated, I will tell the patient that I think their chances of having a good outcome with this surgery is very low and we should consider not operating,” said Dr. Bhanot.

“I’ve done that more and more as I see these patients.

There is a significant percent of these patients we just do not offer surgery to, especially with the costs of some of the materials that we use.”

Component separation techniques are considered the best option for closing large midline defects. Most patients can undergo successful fascial reapproximation, but in 10% to 20% of cases patients will require a bridged repair (Plast Reconstr Surgg 2011;128:698-709).

Bridged repairs are associated with much higher rates of recurrences; two series report recurrence rates of 80% and 89% ((Am J Surgg 2008;196:47-50; Ann Plast Surg 2012;69:394-398).

Dr. Bhanot is a speaker and consultant for LifeCell.

No funding was provided for this study.

INTRODUCING

In hernia repair, a perfect match of

STRENGTH AND

FLEXIBILITY

ETHICON PHYSIOMESH™ and ETHICON SECURESTRAP™ Fixation Device

U Large pore mesh allows for excellent parietal

tissue integration1-3* U The film using MONOCRYL LTM (poliglecaprone 25) Suture polymer is an effective tissue separating barrier1,3* U Exceptional intra-operative handling. Clings to the abdominal wall to ease in placement and can be positioned easily1

U Unique, absorbable “strap” design uses 2 points of

fixation to straddle mesh pores and fibers including large-pore constructions1 U Provides superior holding strength at various deployment angles1 UÊÊStrap is low profile, minimizing foreign material exposure to the viscera1

Call 1-800-4ETHICON or visit www.ethiconsecurestrap.com and www.ethiconphysiomesh.com. *Evidence shown in an animal model.

References: 1. Data on file. Ethicon, Inc. 2. Pascual G, Rodriguez M, Gomez-Gil V,Garcia-Honduvilla N, Bujan J, Bellon JM. Early tissue incorporation and collagen deposition in lightweight polypropylene meshes: bioassay in an experimental model of ventral hernia. Surgery. 2008; 144(3): 427-436. 3. diZerega, G. Peritoneal Surgery. New York, NY: Springer-Verlag; 1999:4-31.

For complete product details, see Instructions for Use. ©Ethicon, Inc. 2011

EP-278-11-7/13

TM

14

Extended Hernia Coverage

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

Society Launches Initiative To Improve Quality, Value of Hernia Repair Program Modeled on Michigan Bariatric Quality Collaborative B Y C HRISTINA F RANGOU

T

he American Hernia Society (AHS) will launch a new quality collaborative this month that is expected to improve standards for ventral hernia care across the country.

At its annual meeting in March, the society will formally kick off the AHS Quality Collaborative, a voluntary performance-tracking system available for all hernia surgeons in the United States.

The program consists of three components: a database that collects detailed clinical information on practice and outcomes on a case-by-case basis, a system for real-time performance feedback to clinicians and a process for continuous improvement based on analysis of the data collected.

“This will be the first time that continuous quality improvement will be applied to hernia repair in the United States on a national level,” said coorganizer Benjamin K. Poulose, MD, assistant professor of general surgery,

Vanderbilt University Medical Center, Nashville, Tenn. Dr. Poulose serves on the AHS Outcomes Committee, which is spearheading the initiative.

“Ventral hernia remains a disease entity that is very common, has wide variation in care (often leading to wasteful care), has less than ideal outcomes, can be very expensive and has many unanswered questions in management. All this leads to poor value for patients and caregivers in the management of ventral hernia,” said Dr. Poulose.

“We hope to not only improve the quality of hernia repair with the [quality collaboration], we hope to improve value as well.”

The program is modeled after the Michigan Bariatric Collaborative, which has been credited with reducing bariatric mortality rates in the state to a fraction of the national average.

“Nothing like this has been done before in the field of hernia. If we can replicate what they’ve done in the field of bariatrics, it’s going to bring tremendous growth and improvement to the wild, Wild West of hernia surgery,” said co-organizer Michael J. Rosen, MD, associate professor of surgery and

www.CMEZone.com Your premier source for practical, relevant and timely continuing medical and pharmacy education

Here are FREE educational activities available now on CMEZone.com Optimizing the Selection and Use of Topical Hemostats Expires April 1, 2013

MN1112

Visit www.topical-hemostats.com

Novel Applications for Biologic Mesh: Innovations in Complex Hernia Repair

MN119

Expires August 31, 2013

Optimizing the Prevention and Management of Postsurgical Adhesions December 1, 2013

MN125

’If we can replicate what they’ve done in the field of bariatrics, it’s going to bring tremendous growth and improvement to the wild, Wild West of hernia surgery.’

—Michael J. Rosen, MD director of the Case Comprehensive Hernia Center, Case Western Reserve University, Cleveland.

For the past several years, the AHS has debated implementing a Centers of Excellence program, similar to the nationwide program that exists in bariatrics. However, the society was turned off by a lack of definitive evidence demonstrating that Centers of Excellence programs produce real improvements in patient outcomes. Moreover, such programs often are polarizing and controversial, and do not have the necessary infrastructure to assess ways to improve the quality of care, said Dr. Rosen.

Instead, the AHS decided to develop its own program that focuses on outcomes rather than processes, includes all hernia surgeons and does not penalize surgeons or hospitals.

Like the Michigan Bariatric Quality Collaborative, the AHS system will employ a database from ArborMetrix, a company founded by John D. Birkmeyer, MD, George D. Zuidema Professor of Surgery at the University of Michigan and a leader in the surgical quality care arena.

ArborMetrix has established quality programs for a number of different national surgical societies and operates nine payer-funded collaboratives for surgical specialties in Michigan.

Dr. Birkmeyer said that the program will focus on long-term measures of effectiveness, things like recurrence, and will capture patient-centered outcomes like pain and functional status.

“A couple of years from now, I expect AHS will serve as a model for how to measure and improve surgical effectiveness, not just safety.”

He added, “I’m really excited about the AHS program and, as a surgeon who sees hernia patients, I plan to participate myself.”

Participating surgeons and their staff will input data to the system on a patientby-patient basis and receive real-time, risk-stratified metrics about the outcomes they can expect. A surgeon would be able to sit down with a patient in front of a computer, plug in the patient’s risk information—things like diabetes, body mass

index, hernia size—and get an assessment of the patient’s expected wound infection rate, mesh infection rate, hernia recurrence rate and improvement in quality of life.

Surgeons can access their own data anytime. They’ll see a dashboard that depicts their own data set against that of their peers, all de-identified.

Hospitals will provide basic information about the hospital stay, such as length of stay and time in the operating room. Eventually, coordinators hope to incorporate a patient-access portal where patients can enter their own data directly into the database.

At regular intervals, analysts will review the data to identify what processes are associated with the best outcomes. “We’ll pick the topic, like surgical site infections, and find out what people can do differently—what antibiotics, what type of prep, what type of operation—to get everybody up to a higher level,” said Dr. Rosen.

Organizers have outlined 10 basic initiatives for the program. They are: 1. Identify the factors contributing to recurrence.

2. Assess quality of life after hernia repair.

3. Reduce surgical site complications.

4. Evaluate potential advantages of laparoscopic repairs.

5. Explore mechanisms of hernia recurrence.

6. Identify factors contributing to mesh infection.

7. Minimize perioperative pain.

8. Evaluate the effect of hernia characteristics on outcomes.

9. Evaluate optimal methods of mesh fixation.

10.Validate an accepted hernia classification system.

To start, the AHS Quality Collaborative will be rolled out to a pilot group of 20 institutions. Eventually, organizers hope to extend the program to inguinal hernia.

The cost of the program had yet to be finalized at press time. Organizers say they expect to charge about $750 per year per surgeon for the first three surgeons at a hospital, and free of charge for additional surgeons. The AHS has invested $250,000 in the Quality Collaboration to date.

KEY POINT The AHS decided against implementing a Centers of Excellence program, and instead developed a program that focuses on outcomes rather than processes, that includes all hernia surgeons and does not penalize surgeons or hospitals.

15

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

PRESIDENTIAL ADDRESS jContinued from page 11

local management of a patientâ&#x20AC;&#x2122;s cycle of care will be included. Also, a patient will describe her role in, and the importance of, a patient-and-family committee for a hernia program.

Another new concept to be presented is a session on learning and improving. The session introduces the concept of clinical quality improvement (CQI). Using the principles of CQI, a clinical program or practice can identify the value of care delivered and identify opportunities for improvement. In a world where the complexity of medical knowledge, techniques, device choices, etc., is increasing at a faster and faster pace, these principles will become more important to apply to our health care system.

In an ever-changing world, we have created problems that will only be solved once we gain a better understanding of our world as a complex and adaptive system.

Other sessions include topics such as the complex abdominal wall repair, managing chronic groin pain and managing sports hernia, as well as two case presentation panels: complex abdominal wall case presentations and a Presidentâ&#x20AC;&#x2122;s Panel during which many current and former hernia society presidents will discuss a variety of hernia case presentations, including video case presentations.

The concept of including diverse stakeholders in the discussion and applying the principles of CQI comes from an evolving science just now beginning to be applied to health care. As quantum mechanics has demonstrated the incompleteness of Newtonian physics, the science of complex adaptive systems has been maturing over the past 100 years.

Despite this matured understanding of our biologic world, our industries, our organizations and even our thinking have continued to be dominantly driven by the principles of reductionist science, developed during the time of the Renaissance. Applying a new understanding will be challenging, but it is not something we can ignore in light of the unsustainable trajectory of our current health care system.

The problems we face today in understanding and improving the value of hernia care is a reflection of the same problems facing our global health care system. In an ever-changing world, we have created problems that will only

be solved once we gain a better understanding of our world as a complex and adaptive system. This kind of â&#x20AC;&#x153;systems thinkingâ&#x20AC;? is what Einstein was referring to when he said, â&#x20AC;&#x153;We will not be able to solve our problems using the same thinking we used when we created them.â&#x20AC;?

The Americas Hernia Society invites you to help collaborate across specialties, engage in dialogue with multiple stakeholders for hernia disease, open your mind to a new kind of science that will help us all learn how to learn and improve the value of care for hernia patients. There will also be plenty of

traditional hernia content that you can learn and use to improve your hernia and general surgery practice.

Even if you are not interested in the evolving concepts of patient-centered care and learning how to apply the principles of clinical quality improvement, we would still like your input about how we can do better: to address the needs of the hernia patient, the practicing surgeon who cares for hernia patients, and for the system as a whole. One forum for this will be a Thursday night dialogue on hernia mesh. After brief TEDlike presentations, there will be an open

discussion between many stakeholders about the value and opportunities for improvement of hernia mesh.

And so, consider coming to Orlando to contribute to creating solutions for our hernia disease and global health care system problems. We need your help and we have a lot of work to do. â&#x20AC;&#x201D;Dr. Ramshaw is the incoming presâ&#x20AC;&#x201D; ident of the Americas Hernia Society and co-founder, chairman and chief medical officer at Transformative Care Institute, and director, Advanced Hernia Solutions, Daytona Beach, Fla.

A Valuable Alternative to Biologics new cho ice f or complex sof t tissue reinf orcement.

Finally â&#x20AC;&#x201C; a cost-effective alternative to biologics! GOREÂŽ BIO-AÂŽ Tissue Reinforcement is a unique non-biologic scaffold that is gradually absorbed by the body. The open, highly interconnected 3D pore structure facilitates cell inďŹ ltration and growth.

Vascularization begins quickly within one to two weeks. t TZOUIFUJD CJPBCTPSCBCMF UJTTVF TDBGGPME t 3BQJE DFMM QPQVMBUJPO BOE WBTDVMBSJ[BUJPO t 7FSTBUJMF GPS OVNFSPVT BQQMJDBUJPOT t "WBJMBCMF JO MBSHF TJ[FT VQ UP DN Y DN With a three-year shelf life and no soaking, refrigeration or tracking required, this versatile material is the easy-to-use, performance-proven alternative that offers value for surgeons and hospitals alike.

Gore. Because material really does matter.

8 - (PSF "TTPDJBUFT *OD t 'MBHTUBGG "; t HPSFNFEJDBM DPN Products listed may not be available in all markets.

GOREÂŽ, BIO-AÂŽ, PERFORMANCE THROUGH INNOVATION, and designs are trademarks of W. L. Gore & Associates. Ă&#x153; 8 - (PSF "TTPDJBUFT *OD "4 &/ +"/6"3:

Visit Gore at AHS Booth # 404/406

16

Extended Hernia Coverage COBRA

jContinued from page 11 repairs and can cost as much as $10,000. Synthetic meshes cost considerably less but the outcomes in these hernia repairs are unknown.

Lead study author Michael Rosen, MD, associate professor of surgery and director of the Case Comprehensive Hernia Center at Case Western Reserve University, Cleveland, called the preliminary results “very provocative,” adding that bioabsorbable meshes may be a costeffective alternative to a very expensive procedure.

“Bioabsorbable costs one-third of the biologic meshes usually used in these repairs. If these results hold up in the long term, bioabsorbable mesh may be a viable alternative to biologic mesh.”

The trial was designed to assess outcomes after use of a bioabsorbable synthetic mesh to reinforce the midline fascial closure in single-stage, open, clean-contaminated and contaminated ventral hernia repairs.

Investigators from nine centers in the United States and Europe enrolled 100 patients since March 2011 and will follow the participants for two years. All patients had a hernia defect of 9 cm2 or greater and a clean-contaminated or contaminated operative field due to a concomitant procedure, open wound or removal of infected mesh.

Preliminary results from the study were presented at the 2012 Clinical Congress of the American College of Surgeons (ACS). At the time, data were available for 34 men and 44 women with a mean age of 58 years and a mean body mass index of 28 kg/m2. They were followed for a mean of nine months (range, one-17 months).

Seventeen wound events (22%) were reported. Thirteen of these were infections, representing a 15% infection rate. Eight infections were superficial; two were attributed to suture-related abscesses. Five deep infections occurred, three following seroma aspiration. Twelve infections resolved in an average of 33 days (one-126 days) with conservative treatment. One patient was still experiencing a superficial infection at the time of the report and a superficial wound debridement was planned. No bioabsorbable material was exposed or required debridement or excision.

Additionally, one patient had a recurrent bowel obstruction as a result of resections performed during the initial hernia repair. The obstruction was resolved with revision of the anastomosis.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

One patient developed a seroma that spontaneously resolved. Another patient developed a hematoma, which required aspiration. Three patients (4%) developed hernia recurrences with an average defect size of 177 cm2, which is acceptably low, said investigators.

It’s unreasonable to compare directly the recurrence rate or wound event rate from this study with those for biologic meshes. Very few published studies have examined recurrence rates after biologic grafts in complex hernia cases, and these included very few patients. Reported recurrence rates range from 0 to more than 50%.

The most significant trial of a biologic mesh, the RICH (Repair of Infected or Contaminated Hernias) study, was performed using Strattice™ Reconstructive Tissue Matrix (LifeCell). In 64 of 80 patients who underwent a single-stage hernia repair with the Strattice, surgeons successfully closed the fascia during the repair. At 24 months of follow-up, 53 patients (66%) experienced 95 wound events. There were 28 unique, infection-related events in 24 patients and 22 hernia (28%) recurrences within two years of the repair (Surgery 2012;152:498-505).

Dr. Itani, who led the RICH study, cautioned against comparing the trials head-to-head. Still, he noted that patients who received the bioabsorbable synthetic meshes appear to have fewer infections at 30 days—15% versus 21%— and fewer seromas.

“These results are very encouraging. Biologics are far from a panacea in abdominal wall reconstruction. A good alternative to biologics which is less costly and has better long-term outcome would be welcome.”

Scott Helton, MD, director of hepatopancreatobiliary surgery at Virginia Mason Medical Center, Seattle, and also an investigator on the RICH study, said the COBRA trial reports that wound events occurred only half as often as what has been reported in other studies in similar high-risk patients. But, he said, that difference might not be due to the type of mesh.

The COBRA investigators are among the most experienced hernia surgeons in the world, and as such, they would be expected to have lower-than-average wound

infections and recurrence, said Dr. Helton. Investigators provided few details on technique in their poster presentation at the ACS but Dr. Helton speculated that their preference for placing the mesh in the retrorectus position might be why their outcomes were so good. Both the RICH trial and other studies have shown that the retrorectus position is associated with low hernia recurrence. Finally, investigators selected patients very carefully for the study.

“There’s a combination of factors at play: good patient selection, optimal timing of surgery, the use of proper technique. All these things collectively, I think, contributed to the study’s good outcomes,” Dr. Helton said.

“What we can conclude is that if they do it this way with h this material, these are their results, which are bettter than just about anything else that’s been published.”

The surgical repairs took a mean of 237±86 minutes. M Most repairs, 94%, were in a retrorectus location with h a mean defect size of 145±122 cm2. Patients spent a m mean of nine days in the hospital and 11 days with h drains in place.

In all, 56% of the study participants underwent a primary ventral hernia repair, wherew aas 44% had repairs done for recurrent hernias.

Many patients underwent concomitant proM ced dures at the same time as the hernia repair.

These included bowel resections (27%), ostomy Th reversals (26%), infected mesh removals (23%), gastrointestinal (GI) fistula repairs (19%), urologic or gynecologic procedures (6%), diverting ostomy creations (4%) and cholecystectomies (4%).

The preoperative risk factors for contamination included contaminated wounds (81%), clean-contaminated wounds (19%), presence of a stoma (46%), presence of GI fistula (18%), presence of nonhealing abdominal wound (23%) and previously implanted mesh (38%).

The patients in the study will be followed for two years and the results will be updated as they become available.

The mesh used in the study was GORE® BIO-A® Tissue Reinforcement and the study was funded by Gore.

Dr. Itani was the author of the RICH trial, which was sponsored by LifeCell. Dr. Helton receives honoraria from LifeCell for teaching and lectures. Dr. Rosen disclosed that he was a co-investigator on the RICH trial and is a speaker for Davol and LifeCell. He has received research grants from Cook, W.L. Gore, and Kensey Nash.

Hernia Repair Forum Buzzes on Facebook

By Christina Frangou

I

n an effort to help optimize outcomes, an American hernia surgeon launched a Facebook group designed to facilitate global collaboration and feedback among all surgeons, physicians, pain specialists, radiologists, industry partners and some patients interested in hernia repair.

Brian P. Jacob, MD, associate clinical professor of surgery at New York City’s Mount Sinai School of Medicine, created the International Hernia Collaboration group as a forum for individuals who want to discuss hernia repair.

Dr. Jacob says the page will foster dialogues similar to those held at physicians’ conferences but on a much bigger scale.

“By embracing social media platforms in novel ways,

like creating Facebook groups to discuss hernia cases, we can suddenly collaborate on a scale, speed and with more people far beyond anything we’ve done in the past,” he said.

“Instead of reaching hundreds of doctors at a conference, we could now reach thousands or tens of thousands across multiple specialties, while simultaneously providing and obtaining feedback to our industry colleagues and patients who have been operated on by us.”

Launched in late December 2012, the site attracted more than 60 international surgeon members within the first week.

Members can use the site to post anything related to hernia, like images, videos or press announcements, or to ask colleagues for opinions on interesting cases.

Dr. Jacob posted about one of his cases on Christmas Day and was impressed at the speed of the response. “While the world was on vacation, I was able to … get feedback from more than nine international hernia experts in three hours.”

To join, all members must have a Facebook account.

They can request to join the group or be invited by an active member. All members must be approved by one of the account administrators.

Patients will occasionally be invited to join and discuss the specifics of their case.

The organizers caution that posts are part of a social forum and patients should never interpret the posts as medical advice.

Anyone interested in the International Hernia Collaboration Facebook group can visit the summary page at www.facebook.com/groups/herniacollab/.

Move beyond to the next generation of biologic grafts.

ÂŽ

The evolution of a proven technology, y Biodesign can help provide reduced recurrence rates in comparison to other biologic grafts. Thatâ&#x20AC;&#x2122;s because Biodesign is completely remodeled into tissue that maintains long-term strength.

Learn more: visit www.cookbiodesign.com.

www.cookmedical.com Š COOK 2013

SUR-BMRADV-BB2-EN-201301

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Surgical Repair Using Biologic Tissue Matrix To Facilitate Tissue Healing: A Case-Based Report Hesham Ahmed, MD Assistant Professor of Surgery UMDNJ–Robert Wood Johnson Medical School New Brunswick, New Jersey

Introduction Surgeons have many prosthetic mesh options available for the reinforcement and repair of soft tissue. For ventral hernia repair, a common type of abdominal wall surgery, the addition of prosthetic mesh has significantly reduced recurrence rates.1 Despite some favorable performance characteristics, synthetic mesh has been associated with complications, particularly in complex repairs.2,3 Biologic grafts have a clinical rationale: Each type is designed to serve as an extracellular matrix (ECM) scaffolding for neovascularization and eventual remodeling of tissue to resemble the native type.4 However, clinical outcomes may be greatly affected by unique characteristics and manufacturing processes that differentiate the available biologic grafts.5 XCM Biologic Tissue Matrix—a sterile, non-crosslinked 3-dimensional matrix derived from porcine dermis—offers preservation of natural fibrous architecture that provides a scaffold for cell ingrowth and proliferation. A proprietary manufacturing process removes cells and DNA for host acceptance, minimizing damage to native tissue architecture.6 XCM has characteristics that make it advantageous for trauma surgery: It’s available in multiple sizes—2 cm × 4 cm to 20 cm × 30 cm—and comes hydrated and immediately ready for use, which eliminates the risk for contamination during soaking.6

Clinical Considerations in Mesh Selection The mesh material and tissue repair technique ideally are determined after assessing patient factors, such as wound characteristics, past medical history and comorbidities, anatomy, and vascularity.1 Mesh-related infection—which has been reported at rates as high as 25%—is a risk factor for hernia recurrence.1 Because mesh-related infection is associated with substantial morbidities like enterocutaneous fistulae and reoperation to remove infected mesh,7 strategies to minimize the risk for infection are important in determining surgical approach, technique, and the choice of mesh material.

In the experience of Hesham Ahmed, MD, assistant professor of surgery at UMDNJ–Robert Wood Johnson Medical School in New Brunswick, New Jersey, the strength of a mesh material is a major clinical concern because the repair must be durable. Mesh strength can affect clinical performance, and a primary goal in soft tissue repair is to avoid splitting and tearing—especially in the early postoperative period.

“In abdominal wall reconstruction, you need to depend on the mesh for a few days or weeks—maybe 2 weeks in this kind of patient. The mesh is very important,” said Dr. Ahmed, who describes his patient population as a mixture of acute

and semi-elective cases including high-risk patients. In preclinical studies, XCM porcine hydrated dermis mesh has been shown to sustain strengths greater than native tissue during the healing process.6,8,9,a Preclinical studies and clinical experience have shown XCM to have high tensile strength, which, as noted by Dr. Ahmed, is an important mesh attribute in abdominal wall repair—one of several soft tissue repair applications for XCM.6,8 In Dr. Ahmed’s practice, having a dependable mesh is paramount. “In trauma, patient selection is not an option, so the features of the mesh that is used are very important,” he said.

In such a time-constrained setting, XCM’s “out-of-the-package” availability for use is a clinical advantage. “With XCM, there’s no hydration time, no orientation, and it’s very thick,” said Dr. Ahmed.

Tissue regeneration and neovascularization are soughtafter performance criteria. Dr. Ahmed described a patient who, after undergoing abdominal wall reconstruction with XCM, “had significant granulation tissue covering the mesh at almost 2 weeks. It’s an advantage when granulation can happen that fast. The mesh is doing what it’s supposed to do, assimilating itself into the natural tissue of the patient.”b In another case that was particularly complex, in which he placed XCM over exposed bowel, “granulation tissue formed very quickly. The patient did very well and fistulae were avoided.”b Finally, elastic properties of mesh can vary significantly.

Human acellular dermal matrix, for example, has shown significant differences in the amount of stretching it offers when used in the hydrated state.10,11 Surgeons have described elasticity as a consideration when selecting a mesh graft, with excessive stretching posing a potential detriment to clinical performance and outcome. In a small prospective study of patients with large, open abdominal wounds, human acellular dermal matrix was associated with a high rate of postoperative laxity at one year.11 Dr. Ahmed, whose experience with a variety of mesh materials has guided his treatment strategy, considers XCM to be a good choice because “it will not provide too much stretching.”

For abdominal wall reconstruction, Dr. Ahmed typically performs component separation (CS) and places mesh using the sandwich technique, which consists of an underlay and an overlay. He finds that the CS approach—which employs native tissue—is useful for avoiding the development of seroma between mesh and fascia.

One of the most important aspects of decellularized ECM mesh materials is the

Bench/Animal Test results may not necessarily be indicative of clinical performance.

b

Results from case studies are not predictive of results in other cases. Results in other cases may vary.

GENERAL SURGERY NEWS • FEBRUARY 2013

Case Presentationb A 48-year-old male was involved in a car accident while wearing his seatbelt. Abdominal and pelvic computed tomography (CT) scans, as part of the trauma assessment, revealed hemoperitoneum. After the scan, the patient became hemodynamically unstable and was emergently taken to the operating room. Because of prior exploratory laparotomy, chevron incision was used to enter the abdomen. Two small bowel resections and a sigmoid colon resection were required.

Due to the patient’s condition, a damage control approach was used and a temporary abdominal closure

Mesh Matters in the Surgeon’s Hands

a

18

combination of strength and integration.12 In the event of an infection, synthetics often require removal; in contrast, dermis-based meshes that incorporate into the repair may not require removal, thus potentially preventing expensive and challenging recurrences.3,12 Dr. Ahmed also has observed a low incidence of seroma formation with XCM in his cases.b His observations are consistent with a study using other biologic meshes that evaluated functional outcomes and host responses to mesh materials that were manufactured with a variety of tissue processing techniques, some of which led to modified collagen matrices.13 Clinically, these processed meshes may be associated with scar tissue, inflammatory responses, graft pleating, and poor integration.13 In addition to good tensile and suture pullout strength, preclinical studies performed in animals have shown that XCM exhibits cellular infiltration and is well integrated while retaining many proteins and cytokines present in native tissue.12

Figure 1. Open wound with enterocutaneous fistula and colostomy.

Image courtesy of Hesham Ahmed, MD.

Supported by

was performed with the intention of returning for a mature sigmoid colostomy and closure of the abdomen within 48 hours. This was performed as planned but post-closure, the patient continued to have a fever and elevated white blood cell count, which required a rescan. Necrotizing fasciitis of the abdominal wall—especially in the left side—was diagnosed and required multiple trips to the operating room for aggressive debridement of the fascia and rectus muscle on the left side of the abdominal wall. He recovered but had complications of enterocutaneous fistula (Figure 1) and wound dehiscence at the chevron incision site.

After prolonged wound care management and the use of a skin graft to cover his exposed bowel and to facilitate the management of his output from the enterocutaneous fistula, the patient was discharged home. He then developed a large hernia, mainly on the left side of the abdomen. Approximately 9 months after the initial injury, the decision was made to reverse the colostomy, take down the enterocutaneous fistula, and perform abdominal wall reconstruction to repair his large incisional hernia. The patient received preoperative bowel preparation and antibiotics. A midline surgical incision was followed by extensive lysis of adhesions, takedown of both the enterocutaneous fistula and sigmoid colostomy, and reanastomosis for large bowel continuity. Subsequently, a large portion of missing rectus muscle and rectus sheath was observed, especially on the left side.

Permanent monofilament sutures were used to approximate the sheath horizontally with some released incisions to be able to achieve approximation to reach the midline.

On the right side, where most of the rectus muscle was preserved, CS was performed in the typical fashion. XCM mesh size 30 cm × 20 cm was secured in a transfascial approach on each side and on 6 points in underlay fashion. Midline fascia was closed with loop polydioxanone suture; figure-of-eight permanent monofilament suturing technique also was used.

Another small piece of biologic mesh was placed in onlay fashion to reinforce the midline repair as part of a sandwich mesh placement technique. Excess skin was removed and vacuum-assisted closure dressing was applied over the

B

Figure 3. Computed tomography scans of the abdomen at initial presentation and following reconstruction.

A) Preoperative large incisional hernia with loss of rectus muscle on the left side.

B) Postoperative scan of the upper abdomen following abdominal wall reconstruction with the XCM Biologic.

Image courtesy of Hesham Ahmed, MD.

mesh (Figure 2). Figure 3 shows CT scans of the pelvic region following abdominal wall reconstruction.

10. Craft RO, Rebecca AM, Flahive C, Casey WJ III, Dueck A, Harold KL. Does size matter? Technical considerations of a regenerative tissue matrix for use in reconstructive surgery. Can J Plast Surg. 2011;19(2):51-52.

Conclusion

11. de Moya MA, Dunham M, Inaba K, Bahouth H, Alam HB, Sultan B, Namias N. Long-term outcome of acellular dermal matrix when used for large traumatic open abdomen. J Trauma. 2008;65(2):349-353.

After 4 weeks, the abdominal wall repair was complete and the patient made good clinical progress. This clinical outcome was facilitated by the use of XCM Biologic Tissue Matrix, which is designed for repair and reinforcement of soft tissue where weakness exists. The structure of the material allows for cellular infiltration. Furthermore, XCM has been shown to sustain strength greater than native tissue during the healing process.6,8,9,a

References 1. Harth KC, Rosen MJ. Repair of ventral abdominal wall hernias. ACS Surgery: Principle and Practice. Ontario, Canada: Decker Intellectual Properties; 2010.

2. Gaertner WB, Bonsack ME, Delaney JP. Experimental evaluation of four biologic prostheses for ventral hernia repair. J Gastrointest Surg.

2007;11(10):1275-1285.

12. Hoganson DM, O’Doherty EM, Owens GE, et al. The retention of extracellular matrix proteins and angiogenic and mitogenic cytokines in a decellularized porcine dermis. Biomaterial. 2010;31(26):6730-6737.

13. Sandor M, Xu H, Connor J, et al. Host response to implanted porcinederived biologic materials in a primate model of abdominal wall repair.

Tissue Eng Part A. 2008;14(12):2021-2031.

Disclosure Dr. Ahmed received funding for his participation in this project.

For more information, go to www.synthes.com, or visit booth #311 and our lunch & learn symposium at the American Hernia Society meeting on March 15th.

3. DiCocco JM, Fabian TC, Emmett KP, Magnotti LJ, Goldberg SP, Croce MA. Components separation for abdominal wall reconstruction: the Memphis modification. Surgery. 2012;151(1):118-125.

4. Harth KC, Rosen MJ. Major complications associated with xenograft biologic mesh implantation in abdominal wall reconstruction. Surg Innov.

2009;16(4):324-329.

J12119-A

Image courtesy of Hesham Ahmed, MD.

A

5. Gaertner WB, Bonsack ME, Delaney JP. Visceral adhesions to hernia prostheses. Hernia. 2010;14(4):375-381.

6. XCM biologic tissue matrix [general brochure]. West Chester, PA: Synthes, Inc.; 2010.

7. Kingsnorth A. The management of incisional hernia. Ann R Coll Surg Engl.

2006;88(3):252-260.

8. Data on file. Kensey Nash Corporation; 2010.

BB135

Figure 2. Vacuum-assisted closure dressing applied to the XCM Biologic following repair.

9. Hackett ES, Harilal D, Bowley C, Hawes M, Turner AS, Goldman SM. Evaluation of porcine hydrated dermis augmented repair in a fascial defect model. J Biomed Mater Res B Appl Biomater. 2010;96(1):134-138.

GENERAL SURGERY NEWS • FEBRUARY 2013

19

20

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

The 2013 Art of

Herniology Happy New Year, Readers!

We are once again in the midst of annual hernia meetings, and with those meetings come debates in the field. This month’s column targets just a few of these debated topics. After reading this column, you may feel that some of the most critical debates were not touched on, but this is simply because this area of surgery is fraught with topics on which many are eager to opine. Don’t fret, for this will not be the sum total of focus on hernia in On the Spot in 2013. You can look forward to the July issue to focus on topics such as the need for (or role

of) randomized controlled trials in hernia care, sportsman hernia, and biologic mesh versus lightweight, large-pore, synthetic mesh in contaminated situations. In the meantime, enjoy reading the opinions from leaders at the forefront of hernia treatment on topics including the Center of Excellence (CoE) model in hernia care, fibrin glue for inguinal hernia over tacks and sutures, and whether component separation is a standard of care.

Responses here vary. Some speak to the need for standard processes and procedures, as well as the need for a collection of longitudinal data to

analyze the effects of these processes.

Other responses illustrate the apprehension surrounding generalizing therapy approaches among subpopulations of hernia patients whose treatment needs vary, as well as defining gold standards and standards of care in this area and generally in medicine. Is herniology a field that demands some type of CoE designation, based on the variations in hernia, hernia care and mixed experience from doctor to doctor? Is herniology a field that demands an individualized approach to treatment? We have yet to see just how the ability to provide that level of care will be affected by changes

O nthe

Spot with Colleen Hutchinson

in our health care landscape such as the Affordable Care Act, insurance company coverage determinations and the growing specializations within general surgery, but these contributors have informed opinions from which we all can learn.

Please feel free to email me at colleen@cmhadvisors.com with any ideas for debate in hernia and other areas of general surgery, thoughts on this month’s column or general feedback. You can comment online as well at www.generalsurgerynews.com. I always like hearing from you!

—Colleen Hutchinson

PARTICIPANTS Parviz Amid, MD, FACS, is clinical professor at UCLA Lichtenstein-Amid Hernia Clinic, David Geffen School of Medicine at UCLA, Los Angeles.

Karl A. LeBlanc, MD, MBA, FACS, is associate medical director at Our Lady of the Lake Physician Group, director and program chair of Fellowship Program, Minimally Invasive Surgery Institute, Baton Rouge, Louisiana.

Bruce Ramshaw, MD, is co-founder, chairman and chief medical officer at Transformative Care Institute, and director, Advanced Hernia Solutions, Daytona Beach, Florida.

Steven Bowers, MD, is assistant professor of surgery, Mayo Clinic, Jacksonville, Florida.

Adrian Park, MD, is chair, Department of Surgery, AAMC Surgical Specialists, Annapolis, Maryland.

William Richards, MD, FACS, is professor and chair, Department of Surgery, University of South Alabama, Mobile.

David Chen, MD, MD, FACS, is assistant clinical professor at UCLA Lichtenstein-Amid Hernia Clinic, David Geffen School of Medicine at UCLA, Los Angeles.

Alfons Pomp, MD, FACS, FRCSC, is chief of laparoscopy and bariatric surgery, vice chairman, Department of Surgery, and the Leon C. Hirsch Professor of Surgery and attending surgeon at the NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York City.

Michael J. Rosen, MD, FACS, is associate professor of surgery and chief of the Division of GI and General Surgery at University Hospitals of Cleveland, Case Medical Center, and the director of the Case Comprehensive Hernia Center, Cleveland, Ohio.

Benjamin S. Powell, MD, FACS, is with Mid-South Center for Minimally Invasive Surgery, Germantown, Tenn., and is assistant professor of surgery, University of Tennessee Health Science Center, Memphis.

Michael G. Sarr, MD, FACS, is the J.C. Masson Professor of Surgery and vice chair of research in the Department of Surgery at Mayo Clinic, Rochester, Minnesota.

Aurora D. Pryor, MD, is professor of surgery and vice chair for Clinical Affairs, chief, general surgery director, Bariatric and Metabolic Weight Loss Center, Department of Surgery, Stony Brook University School of Medicine, Stony Brook, New York.

Guy R. Voeller, MD, is professor of surgery, University of Tennessee Health Science Center, Memphis.

Neil Hutcher, MD, is chairman, Board of Directors, and chief medical officer and vice president of clinical quality and compliance, Surgical Review Corporation, Raleigh, North Carolina.

Jarrod P. Kaufman, MD, FACS, is general and advanced laparoscopic surgeon, Advanced Surgical Associates of Central Jersey, Freehold, New Jersey.

see HERNIA DEBATES page 22

HOLD FAST WITH EVERY PASS ETHICON INTRODUCES NEW STRATAFIX™ SPIRAL KNOTLESS TISSUE CONTROL DEVICES

A comprehensive portfolio for multiple surgical applications.

Consistency More consistent tension control and approximation during closure*

Security Strength and security of interrupted suturing without knot-related complications1-4

Efficiency More efficient than continuous suturing*

For more information, contact your Ethicon representative or call 1-800-255-2500 For complete product details, see Instructions for Use. *

Compared to traditional sutures.

References: 1. Data on file, Ethicon, Inc. 2. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178. 3. Rodeheaver GT, Pineros-Fernandez A, Salopek LS, et al. Barbed sutures for wound closure: in vivo wound security, tissue compatibility and cosmesis measurements. In: Transactions from the 30th Annual Meeting of the Society for Biomaterials; Mount Laurel, NJ; p. 232. 4. Vakil JJ, O’Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713 © Ethicon, Inc. 2012 SFX-462-12

22

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

HERNIA DEBATES

re e

The Center of Excellence (CoE) model is the best model to ensure the highest-quality clinical outcomes for a hernia program.

ag

e gre

D

is

A

jcontinued from page 20

Dr. Pomp: Disagree. The CoE designation is overused and no longer carries any significance. It makes more sense to mandate adherence to a quality improvement program using metrics determined by a specialty society and vetted by a recognized organization like the American College of Surgeons (like the NSQIP [National Surgical Quality Improvement Program] in bariatric surgery). The problems, of course, are longer-term follow-up, which is notoriously difficult, and establishing an appropriate and objective risk adjustment mechanism to be able to compare outcomes.

Drs. Amid, Chen: Agree. Any attempt to standardize and advocate quality and monitor outcomes is favorable as long as credentialing and validation is determined by an outside, impartial party with uniform standards.

Dr. Park: It is a model, but by no means is it the only or even best model to examine high-quality care and outcomes. I suppose it could be argued that many such programs exist in this country without such a designation, where skilled and dedicated hernia surgeons and caregivers in highly protocolized environments track all they do.

Dr. Ramshaw: Disagree. The CoE model would work well for a more static and less complex application. Although the concepts of standardization of protocols and centralized data management can help minimize very poor outliers, that same model inhibits ongoing adaptation and improvement. We will need to apply principles of clinical quality improvement, where dynamic care processes are defined and managed locally, and value-based outcomes measures

are used in real time to improve those dynamic care processes. Also, engaging the patient and family in the process definition and quality improvement is essential to maximize improvement.

Dr. Kaufman: Agree. This has been used most notably with bariatrics and breast cancer, as well as other health care areas, and is an excellent strategy to allow standardization of technique(s) and protocols for different types of hernias and the best manner to approach these types of repairs.

Dr. Bowers: Disagree. The true drivers of quality in hernia repair (chronic pain and hernia recurrence) cannot be accurately measured in the current U.S. system. To make a claim of “excellence” based on perioperative outcomes is ridiculous.

Dr. Sarr: Ideally yes, but then again it depends on whether the CoE criteria are based on documented outcomes or the facility. This has been a big problem for many programs, where the CoE criteria are not outcomes but rather number of cases and a facility having all the bells and whistles.

‘The true drivers of quality in hernia repair (chronic pain and hernia recurrence) cannot be accurately measured in the current American system. To make a claim of “excellence” based on perioperative outcomes is ridiculous.’

—Steven Bowers, MD Dr. Rosen: Several years ago, I would have answered this question with a resounding “yes!” However, as I have learned over the past few years, CoEs simply have not done what we wished they would. I think hernia surgeons cannot overlook the failure in the bariatrics model. To my knowledge, there are little to no data that actually support that CoEs have done anything to improve quality of care. Although they have compiled ample data, the actual feedback methods and quality improvement mechanisms were never clearly

23 23

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

thought out. I think that CoEs will be divisive in hernia surgery and will polarize surgeons and prevent improvement in quality. However, there is an answer, and it is forming quality collaboratives.

This model allows surgeons to work together to compile meaningful data, analyze it based on appropriate risk stratification, provide feedback loops to allow surgeons to see differences in outcomes, and most importantly provide a measurement in improvements in quality of care. The American Hernia Society's Quality Collaborative is now being released [see page 14 for story], and I would encourage all surgeons who want to improve the quality of care they give hernia patients to join.

Dr. Powell: Agree. Hernias continue to be bread-and-butter cases for the practicing general surgeon in the community.

The hernias that tend to find their way to academic centers tend to be the more complicated, recurrent types. Any model that allows for clinical outcomes research such as a CoE does potentially allow for better care of the complicated hernia patient.

Dr. Voeller: Disagree. Many of the CoEs in hospitals are all about marketing and true quality is not the main focus. The way to ensure high quality is better training and analysis of results of surgeons and applying continuous quality improvement analysis to the surgeons and their techniques. SAGES [the Society of American Gastrointestinal and Endoscopic Surgeons] is looking at better training through the Hernia Task Force and the American Hernia Society is looking at quality improvement through the Hernia Outcomes Group.

Dr. Pryor: Disagree. CoE programs have gained in popularity over the past several years, and are now necessary for insurance coverage in many specialties.

However, for a broad field central to general surgery such as hernia, such programs are not practical. Additionally, tracking true outcomes requires extensive followup that is less common in many hernia practices.

Dr. Richards: Absolutely not, because the hernia repair should be in the domain of every general surgeon.

Dr. LeBlanc: Disagree. I do not believe that the CoE model will assure this because the usual model requires a certain minimum number of cases to be included.

Sometimes all the required items in such models really do not achieve a meaningful difference in outcomes. I would venture to guess that very few of the experts on this panel are participants of a CoE program.

Additionally, I am unaware of validated standards for any CoE hernia program that

is certified by either the American Hernia Society or European Hernia Society.

Dr. Hutcher: Agree. I understand the controversy and fears associated with this concept; however, using bariatric surgery as a model, several benefits are evident. Standardization of processes and procedures coupled with robust collection and review of data is worthwhile. Even considering the increased rate of minimally invasive surgery and introduction of the [gastric] band, the mortality of bariatric surgery has continued to drop along with the

‘An independent CoE with input from hernia leaders with credible data will allow this specialty to not only survive health care reform, but to thrive.’

—Neil Hutcher, MD [hospital] length of stay—to the point that the insurance industry tried to declare all bariatric surgery be done on an outpatient basis. The fact that surgeons had their own data on more than 400,000 patients (CoE database), this inappropriate assault was reversed. An

independent CoE with input from hernia leaders with credible data will allow this specialty to not only survive health care reform, but to thrive. We all will be accountable for outcomes, cost, transparency and patient satisfaction. see HERNIA DEBATES PAGE 24

24

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

Component separation is the standard of care.

re e

e gre

the neurovascular anatomy of the anterior abdominal wall. The lack of good comparative data, with relatively short-term follow-up, and a broad spectrum of patients undergoing this procedure prevents the classification of standard of care at this point.

Dr. Voeller: Standard of care for what? I am always hesitant to use a legal term when talking D about surgery. Lawyers love it when we doctors say something is the standard of care. Component separation is an important tool for herniologists to understand and be able to apply as they see fit. As I see it, its role is still being defined.

is

ag

A

jcontinued from page 23

Dr. Park: Not so much!

Drs. Amid, Chen: Selectively. Component separation in patients who have large defects and an adynamic abdominal wall is a crucial adjunct to successful repair and restoration of function.

Dr. Sarr: Disagree. Too many people are having a separation of components (in my opinion because the charges for the procedure are so exorbitant—a crime for a procedure that takes 20 minutes, but the surgeon can charge an inordinate amount of money)—not all hernias need it!

Dr. Pomp: It certainly seems so given the recent epidemic of courses, seminars and publications. Nonetheless, it is my experience that component separation without medial and/or lateral reinforcement with nonabsorbable mesh that the recurrence rate is unacceptably high.

Dr. Bowers: It is the gold standard for tissue coverage of the midline abdominal wall, but it has not been determined that the functional outcomes of [the component separation technique] are superior to bridging mesh repair. Many of us are working on that.

Dr. Pryor: Disagree. Although component separation is a great tool to facilitate native tissue abdominal wall reconstruction, it is not the ideal technique for repair of all hernias in all patients. Therefore, I consider it an acceptable option, but not standard of care.

Dr. Richards: It’s not standard of care, but it is a really valuable technique in the right circumstances.

Dr. LeBlanc: It is the standard of care in “the appropriate setting.” The issue here is the term appropriate setting, as well as the fact that there are many variations of the component separation procedure itself. There are many other unanswered questions such as should mesh

Fibrin glue for inguinal hernia should be the preferred use over tacks or sutures.

re e

e gre ag

A

Dr. Rosen: I think the term component separation has really led to a lot of confusion about abdominal wall reconstruction. In principle, there is a multitude of ways to perform this procedure. Although each has its own advantages and disadvantages, in my opinion the key point is to understand the objective of the procedure and not necessarily how one performs it. In practice, the concept of a component separation is to reapproximate the midline. This should be done in the least invasive way possible, while providing adequate advancement, as well as preservation of

Dr. Powell: It is the standard of care for improved cosmesis and returning a functional abdominal wall.

For patients with larger defects, it is the best method when coupled with mesh prosthesis. For patients with small Swiss cheese—type defects, laparoscopic ventral hernia repair still plays a role.

is

D

D r . Voeller: My favorite topic.

I don’t think we should say preferred because sutures and tacks, when used properly, give very good results. However, since 2003, in more 1,500 inguinal repairs, I have used fibrin glue for my TEP [totally experitoneal procedure] and Lichtenstein repairs and it is my method of choice. I can use the glue for fixation where tacks are not safe laparoscopically. Excellent experimental studies by Kes, Schwab, Katkhouda and others show the many advantages of fibrin glue. There are also many, many clinical studies that support its superiority over tacks.

Dr. Pomp: Fibrin glue is expensive and confers little advantage over no tacks or sutures in a TEP repair. It may serve some function in TAPP [transabdominal preperitoneal] repairs to close the

peritoneum, but I have had no episodes of inguinodynia/nerve entrapment even in thin patients with absorbable tacks.

Dr. Park: There is only a handful of small prospective randomized trials addressing this question, none of them multicentered. So I would not yet agree that it is the preferred fixation modality.

Drs. Amid, Chen: This depends on the method of operation and the type and size of hernia. Although data have been favorable, we still need longerterm evidence, particularly for direct and large hernias.

Dr. Sarr: It’s debatable. Another trial that needs to be done using the same prosthetic!

be used? If so, which mesh? Where should it be placed?

Although there is definitely a need for this procedure, and I do believe that there are still many issues related to its use, the biggest problem with it is the fact that there are many surgeons performing the procedure with little understanding of its anatomic changes and the resulting physiologic alternations, including the management of its frequent complications.

Dr. Ramshaw: Disagree. For any complex medical condition, there can never be a “standard of care.” Any “best practice” will be of value and help many patients.

However, that same “best practice” also will be of less value than other options for some patients and may actually harm some patients. We are beginning to see this throughout health care, from screening tests, such as breast mammography, to drug therapies and invasive procedures. We need to gain a better understanding of how to apply the best therapy for each patient subpopulation, not as a “best practice” or “standard of care” for all patients.

Dr. Kaufman: This may not be considered the standard of care at this time secondary to the fact that many surgeons may not yet be sufficiently experienced with this technique. It has evolved to either anterior or posterior TAR [transversus abdominis release] techniques.

These are applied to different types of patients and in different settings based on how much fascial advancement is required. This should be used as an adjunct procedure in the setting where closure of the midline is not possible, so that you can assure tension-free closure of the linea alba where it would not otherwise be able to be achieved.

Dr. Hutcher: On the fence. This is an important tool in difficult situations, especially in contaminated wounds, recurrences and trauma. I don’t believe there are enough data from multiple sources to label it as standard of care, which is a term that only further emboldens plaintiff attorneys.

Dr. Powell: I currently use fibrin glue for my TEP repairs and think it works nicely. It doesn’t cost more than a tacker, and allows the mesh to conform nicely to the preperitoneal space. Earlier this year, there was a study that demonstrated a similar recurrence rate with tacks and fibrin glue, but the patients with tacks had more pain at three months postoperatively. Longer-term data are somewhat lacking. There have been a few other studies that lean toward similar results.

It is likely that more and more surgeons will use glue for their laparoscopic inguinal hernia repairs going forward.

Dr. Kaufman: This approach should be studied in a randomized controlled trial with head-to-head comparisons to all of the available products on the market. There is a great deal of variability with the properties of the current glues that are available on the market. When the ideal glue is identified, fixation will be readily achieved without tacks or sutures. This transition should have a significant effect on postoperative pain

and may completely alleviate periostitis pubis sometimes seen with laparoscopic hernia repairs.

Dr. Ramshaw: Disagree. It is not that simple. Although I think glues do play a role in improving the value for the patient, we will need to apply the principles of clinical quality improvement and determine the real value of products and techniques over the patient’s entire cycle of care to determine where glues have the best value and where other fixation strategies have the best value. For a complex medical problem, there will rarely be one strategy that has the best value in all situations.

Dr. Rosen: I am not sure it is preferred over tacks or sutures, but it definitely should be considered. One of the biggest advantages of fibrin glue is that it allows you to secure the mesh over the vessels and triangle of pain without risk of neurovascular injury. I think for those surgeons who use no fixation, this is a very viable option.

2 25

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

GUT REACTION: TOPICS IN SURGERY Contributor

Nowadays, residents and fellows must …

True or false: Industry support is a necessity for innovations in surgical technology in the United States.

“Obamacare” …

The best hernia patient understands that …

The general surgeon of 2013 needs to be …

When we are all retired and a case requires conversion to open surgery, it’s likely that …

This column …

Dr. Park

Make it to the occasional clinic!

True and vital to advancing the field

Is here to stay. Deal.

We share responsibility for their outcomes. outcomes

Employed, sadly!

Our avatars will be activated

Is w Is worth orth tthe orth or he rread he eadd ea

Dr. Pomp

Learn more, in less time and by doing fewer operations

True (and now seriously, paradoxically, negatively affected

by AdvaMed and overregulation by overzealous IRBs)

Too complex for me to understand.

Statistics of recurrence and inguinodynia are related to population groups and not individuals.

A specialist who is aware he/she can’t do everything better than everyoneff

The “new” surgeons will do it just fine.

Shows great minds (and this old fool) don’t always think alike

Dr. Rosen

Make every second count

True, whether you like it or not

We’ll see.

They have to be a part of the solution.

More of a businessperson than we wish

If you make a big enough incision, anyone can do it.

Should be done every month!

Dr. Powell

Scrub [in on] any and every case they can

True

Still figuring it out

A perfect abdominal wall isn’t possible.

Open to change going forward

Fewer surgeons will feel comfortable.

Glad to participate!

Dr. Ramshaw

Practice empathy, learn how to learn

True, but in a new way

Brings us to the edge of chaos

My care is complex. I’ll help.

Helping transform healthcare, not self-focused

A new training paradigm will prevent disaster.

Shows diversity of thinking

Dr. Richards

Document cases to support their future practice

Absolutely, unequivocally true

Will never change the Recuperation requires a fact that people need and lot of time. value good surgeons

On call for emergencies

They will muddle through.

Rocks

Dr. Kaufman Enter “uncharted waters” of health care

Generally true

Will negatively impact our ability to be patient advocates

Hernia techniques continue to evolve.

Cost conscious and an advocate for our profession

Open surgical experience will likely be lacking.

Is always interesting to me!

Dr. Voeller

Truly want to be the best

Yes

Some good, a lot bad

Weight loss is key.

Independently wealthy to survive

It was necessary.

I like the statement section best.

Dr. LeBlanc

Learn the anatomy

True

The ruination of U.S. health care

It’s not “just a hernia” repair.

An efficient surgical businessperson

No surgeon will know how.

Allows us to pontificate

Dr. Hutcher

Must continue to be mentored for several years

True but under strict supervision

Is designed to destroy private insurance.

They have responsibility in reducing recurrences.

Treated as an endangered species

We’ll be in trouble.

Shows need for less art/more science.

Dr. Amid/ Chen

Learn both the “old” and the “new”

True, with safeguards to ensure honesty

Greater good

Alternatives and all surgery have risks.

Up to date on evidence- It is safer and will take based medicine longer.

Dr. Sarr

Spend greater time on their education

True

No one knows what it is!

Recurrence and nagging discomfort will be possible.

Open-minded and plastic—able to change

There may not be many truly trained surgeons to do it

A good idea

Dr. Pryor

Learn to evolve their practice over time

True

Mixed feelings

Hernia repair can mean major surgery.

Flexible and knowledgeable about a variety of techniques

Surgeons won’t be as comfortable with open as laparoscopic.

Is fun debate

Dr. Bowers

Make the extra effort

False

Bad for old surgeons, good for young surgeons

It’s gonna hurt.

Compulsive about quality

You get to wear a bag.

I read it

Hutchinson

Each response here is a sound lesson for all residents and fellows.

“True” wins by a landslide.

Complexity and apprehension summarize the majority of responses.

Management of expectations and responsibility appears to be key.

A businessperson!

Hope to not be that patient

Great fun!

Is insightful

IRB, institutional review board

Dr. Pryor: I still prefer tacks, although g I now use absorbable ones, and use them sparingly in the groin. I also use suture fixation for ventral hernia mesh.

Dr. Bowers: Lightweight mesh should be fixated.

Dr. Richards: I continue to use tacks for the laparoscopic repair and suture for open repair.

Dr. LeBlanc: There is enough evidence to support this claim. At the very

least, fewer sutures should be chosen and absorbable ones at that. I do not believe that permanent tacks should be preferred for an inguinal hernia repair, especially the open method. Permanent products (sutures or tacks) result in an increased incidence of chronic inguinodynia. There are a few products available that require no fixation of any kind (which might be the future of meshes in inguinal hernia repair).

previously had tacks. I have found these tacks migrated g in everyy nook and crannyy of the abdomen, including deep in the wall of the colon, small bowel and iliac artery. My experience with glue in surgery and home repairs has never lived up to advertisements. I keep coming back to the database. Each of these questions could have its own module for detailed study.

— Colleen Hutchinson is a Disclosures

Dr. Hutcher: Disagree—my short answer is neither! I have done laparotomies on many patients who have

Transenterix; having stock options in Barosense and beingg a speaker p ffor and receivingg research support from Novadaq. Dr. Ramshaw reported offering speaking, teaching and/or advisory board services to Atrium, Bard/Davol, Baxter, Covidien Ethicon, LifeCell, Novus Scientific, MTF, STS and WL Gore.

Dr. Rosen reported being a speaker for Davol and Lifecell and reciving a research grant from W.L. Gore. Dr. Pryor reported owning stock in

communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached hd at colleen@cmhadvisors.com.

Atrium Is Your Full Line Hernia Mesh Provider TacShield™:

C-QUR™ Mesh:

Symmetrical fixation apron with an O3FA coating

Strength and handling with an O3FA coating

V-Patch™: Anchoring & deployment with an O3FA coating

ProLoop™ Plug:

CentriFX™:

ProLite™ Mesh:

Anatomically correct 3D design with O3FA

Bare polypropylene for maximum strength

C-QUR™ FX Mesh:

ProLite™ Ultra Mesh:

O3FA filament coated for complete healing and incorporation

Light weight 3D polypropylene plug

Ultra light weight bare polypropylene

HANDLING • HEALING • REINFORCEMENT Understanding the need to meet financial goals with dependable products, Atrium Medical is a full-line hernia mesh provider, delivering economically and clinically valuable solutions for all hernia procedures.

Atrium is now part of MAQUET GETINGE GROUP

To learn more about Atrium’s hernia products please call: 1-800-528-7486 or visit our website www.atriummed.com ©Atrium Medical Corporation 2013. All rights reserved. Atrium, C-QUR, CentriFX, TacShield, V-Patch, ProLite, ProLite Ultra and ProLoop are trademarks of Atrium Medical Corporation, a MAQUET GETINGE GROUP company.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

Dear Readers, Welcome to the February issue of The Surgeons’ Lounge. This month, Ann M. Rogers, MD, director, Penn State Surgical Weight Loss Program and associate professor of surgery, Penn State Milton S. Hershey Medical Center, Hershey, Pa., discusses the case of refractory strictures and ulcers after gastric bypass.

And finally, the answers to the remaining two challenges from the December 2012 issue!

In the next issue, our guest expert will be Jacques Himpens, MD, consultant surgeon and expert in obesity surgery and general surgery, in Belgium.

I look forward to your questions, comments and feedback.

Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org

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

Surgeon’s Challenge No. 2

Surgeon’s Challenge No. 3

Collaborator: Yaniv Cosacov, MD, University of Debrecen Medical and Health Science Center, Debrecen, Hungary

Collaborator:: Nicholas L. Cukingnan Lee, MD, Sydney, Australia

45-year-old woman presented for a Roux-en-Y gastric bypass procedure. Her weight was 390 pounds and her body mass index [BMI] was 66.9 kg/m2.

Her past medical history consisted of multiple medical problems including asthma, hypertension and osteoarthritis, which were treated with bronchodilators and anti-inflammatory drugs (valsartan and hydrocodone/acetaminophen, respectively). Due to poor exercise tolerance and chronic shortness of breath, the patient was essentially bound to her wheelchair (obstructive sleep apnea [OSA] evaluation was negative). She also was diagnosed with dysthymic and anxiety disorders, for which she was treated with several antidepressants and anxiolytics (citalopram, amitriptyline, bupropion and

A

buspirone). She previously had undergone ankle, knee and back surgery, as well as tonsillectomy and sinus surgery.

The patient appeared well and a review of systems and physical examination were all within normal limits. All preoperative lab results and radiological tests were within normal limits. Once access was gained to the peritoneal cavity, the liver appeared enlarged and cirrhotic with multiple, white patchy lesions in all lobes (Figure).

What would you do?

Answer During the procedure, the liver was found to be cirrhotic with many surface lesions. The decision was made to abort the procedure.

A liver biopsy was performed and sent for frozen section evaluation. The latter revealed a necrotizing granuloma, suspected to be of a mycobacterium complex nature. This case was referred to the Infectious Disease Department to work up the patient’s condition. The QuantiFERON test (Cellestis Limited) for the diagnosis of tuberculosis was performed and the results were negative. One of three sputum cultures was acid-fast bacillus–positive, but cultures failed to grow mycobacteria at 46 days. Two weeks postoperatively, the patient was diagnosed with sarcoidosis

The patient is a 50-year-old woman who presented to the clinic for a second opinion regarding her epigastric pain, nausea and vomiting that she had had for the past two years. She had undergone a Rouxen-Y gastric bypass with silastic ring (Figure) 10 years earlier at an outside facility. Her proton pump inhibitor dose was increased and the patient noted improvement of symptoms. One month later, another esophagogastroduodenoscopy [EGD] was performed at our facility, which showed a small ulcer in the jejunum. The patient was admitted the following weekend to treat three episodes of melena.

An upper gastroenterologist was then consulted for a double balloon endoscopy, which showed no significant pathology in the jejunal loop and healing of the ulcer. There also was a ring-like dark object seen penetrating the gastric mucosa of the remnant stomach above the pylorus and two ulcers at the points where this object made contact with the gastric mucosa. These findings led to the diagnosis of an eroded gastric ring to remnant.

What would you do if endoscopic removal of this ring was not feasible?

Answer after a computed tomography (CT) scan showed that granulomatous disease had spread through both lungs as well as mediastinal adenopathy, which was confirmed by biopsy. The patient was started on 10 mg of prednisone twice daily.

A chest X-ray four months later showed no pulmonary infiltrates and no pleural effusion. The patient was brought back to the operating room for a sleeve gastrectomy instead of a Roux-en-Y gastric bypass, which was uneventful. Because of the patient’s history of sarcoidosis, she was restarted on prednisone on postoperative day (POD) 1 and discharged on POD 3.

It was decided to operate on this patient and retrieve the ring via the gastric remnant, using a minimally invasive technique. Lysis of adhesions was performed between the small bowel and the omentum, and the pouch and the omentum. Once the gastric remnant was identified, the short gastric vessels on the greater curvature were taken down with the Harmonic scalpel (Ethicon Endo-Surgery), as far up as the mid-greater curvature. A gastrotomy was then performed at the antral region and, with the aid of a laparoscope, in an endo-organ fashion. The eroded silastic ring was localized in the prepyloric area, as indicated in the previously performed double balloon endoscopy.

The ring was divided with endoscissors and removed. The gastrotomy was closed with endostaplers through a partial remnant gastrectomy. The staple line was oversewn with running 2-0 silk suture.

Finally, a drain was placed in the subhepatic left upper quadrant spaces and the specimen retrieved through the supraumbilical trocar site. The patient was discharged on postoperative day (POD) 2 and was able to tolerate an oral diet. On her last office follow-up visit six months postoperatively, the patient had complete resolution of her initial symptoms. continued ON page 28

27

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

jcontinued from page 27

Dr. Rogers’

Reply

Question for Dr. Rogers

This patient is quite symptomatic, and requires frequent invasive procedures as well as blood transfusions in order to function. It is likely she will require surgical revision. After acute stabilization, including the use of PPIs and mucosal barriers, if not already instituted, it is important to assess and optimize

Vinay Singhal, MD, and Tung Tran, MD Hershey, Pennsylvania

43-year-old woman presented to the emergency room with nausea, vomiting and epigastric abdominal pain, nine years after she underwent a laparoscopic gastric bypass at another institution. She reported having had recurrent strictures and ulcers at the gastrojejunal anastomosis since the time of the bypass, and undergoing multiple, annual upper endoscopies and stricture dilations performed by her original surgeon.

She was able to eat solid food for two to three weeks after each dilation, but then felt a tightening to the point that she was only able to orally ingest liquids. The patient also required intermittent transfusions for blood loss. She had undergone several abdominal computed tomography scans and upper gastrointestinal (GI) contrast studies, but no cause for her symptoms was identified. Three years before this admission, the patient was told her symptoms were most likely related to a stagnant limb syndrome, and she underwent laparoscopic resection of the reverse alimentary limb segment. She continued to have unrelenting strictures and marginal ulceration, despite maximal therapy with a proton pump inhibitor (PPI) and mucosal barrier medication. Because of frequent absences from work, she lost her job as a medical assistant. Eventually, she was urged to seek a second opinion elsewhere. Her past medical history was significant for iron-deficiency anemia, Prinzmetal’s angina, anxiety and depression. Workup on this admission included an upper GI contrast study that showed a 12 cm–long gastric pouch (Figure 1), with a right angle anterior take off of the gastrojejunal anastomosis. An upper endoscopy showed a pinhole stricture and after partial dilation and clearance of some minor bleeding, a large marginal ulcer was seen (Figure 2).

A

Questions: How would you evaluate this patient for possible revisional surgery?

What are the common causes of refractory strictures and ulcers after gastric bypass?

What surgical approach would you take?

Figure 1.

Figure 2.

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) ( )

50

P P<0.05

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

–33%

+ PCA morphine (n=52)

Significant improvement over placebo + PCA morphine

Morphine (mg)

1.2

Pain relief

28

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

2

3

4

5

6

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.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

a patient’s nutritional status prior to contemplating a revision. One should obtain previous operative notes and records to aid in understanding what operations were actually done, as well as illuminating what nutritional education, if any, she received. A thorough medical and psychological evaluation is also essential in any patient needing elective, revisional surgery, particularly for patients who have undergone surgery at an outside institution.

Marginal ulceration and strictures after gastric bypass are more common in smokers, drinkers, and nonsteroidal

anti-inflammatory drug and steroid users, patients on chronic anticoagulation medication, and patients with Helicobacter pylorii infection. If possible, these factors must be evaluated and corrected. Another major cause is anastomotic ischemia, related to either the anatomic construction or diabetes.

Foreign material at the anastomosis is another potential cause, as is the creation of a stapled but nondivided gastric pouch. An excessively long pouch also can lead to marginal ulceration on the basis of additional acid-producing cells in the area. Similarly, gastrogastric

fistulae are a relatively common cause of marginal ulcers due to acid backwash from the native stomach.

Patients with refractory strictures and ulcers should be evaluated using an upper GI contrast study—making use of the left lateral decubitus position to better evaluate for fistulae—and upper endoscopy. However, one rare but serious cause for refractory ulceration at the gastrojejunal anastomosis is a Roux-enO malformation, in which the biliopancreatic limb is erroneously anastomosed to the gastric pouch. Because a jejunojejunostomy is still created in such a

From the start.

Administer OFIRMEV pre-op, then sched dule q6h CONTINUE WITH OFIRMEV IF:

Schedule hed d l OFIRMEV RM q6h for or first 24 hours

• Parenteral analgesia is clinically warranted • Coompromised GI absorption or inability to take oral analgesiccs • 1000% bioavailability desired

TRANSITION TO PO ANALGESIA WHEN: • PPatient ti t can ttake k andd absorb b b orall analgesics l i

Visit OFIRMEV.com to watch educational videos, download clinical case studies, register for live webinars, and much more

©2012 Cadence Pharmaceuticals, Inc. All rights reserved.

OFIRMEV and the OFIRMEV dot design are trademarks of Cadence Pharmaceuticals, Inc.

OFV1132A1112

OFIRMEV.com

scenario, there will be drainage of contrast through that route, so this abnormal configuration may be difficult to diagnose using contrast studies alone. A probe manometry and a hepatobiliary iminodiacetic acid (or HIDA) scan can be useful adjuncts to evaluate for retrograde propulsion through the presumed alimentary limb.

Covered metallic stents are sometimes useful in the treatment of recurrent strictures associated with ulceration at the gastrojejunal anastomosis. However, deep ulcers, ulcers taking up a CONTINUED ON PAGE

34

29

30

In the News STRONG

FOR

jcontinued from page 1

SURGERY

that makes the difference in outcomes, but that’s not the whole story. We can often identify patients who are going to have a good outcome or a bad outcome when we see them in the office and that’s the time to intervene,” said David Flum, MD, a general surgeon at the University of Washington who came up with the idea for Strong for Surgery.

Dr. Flum, who led the creation of the state’s quality program, the Surgical Care

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

and Outcomes Assessment Program (SCOAP), is partnering in the Strong for Surgery initiative together with the University of Washington’s Comparative Effectiveness Research Translation Network and the American College of Surgeons’ Education Division.

Strong for Surgery aims to get patients in peak shape for surgery by targeting the known patient risk factors for poor outcomes, specifically those risk factors that can be addressed in a period of several weeks or months. The initiative is focused on four key areas: preoperative nutritional status and the use of

immunonutrition, glycemic control and diabetes management, smoking cessation and medication use.

Preoperative counseling and patient engagement are things that bariatric surgeons have done for years. But outside of bariatric surgery, surgeons have not routinely required patients to modify their high-risk factors.

Organizers hope that patients can help bring about a “move-the-needle kind of improvement in outcomes that we’ve been looking for, for 20 years,” said Dr. Flum.

Other quality initiative programs

such as SCOAP and the National Surgical Quality Improvement Program have whittled away at surgical complication rates by targeting the actions of surgeons and hospital staff once a patient is admitted, said Dr. Flum. By doing so, they have missed some of the most critical elements when it comes to patient outcomes. Study after study has shown that the modifiable factors that bear the greatest influence on outcomes are not always things like surgeon volume and operative times; rather, they are patient characteristics like smoking, nutritional status, glycemic control and medication use.

For instance, malnourished patients undergoing surgery for gastrointestinal (GI) cancer have more than 10-fold increased morbidity. That’s often a problem that can be identified on a standardized screening and addressed with a nutritionist’s intervention. Another example: Among patients who do not have malnutrition but are planning to have GI surgery, a five-day course of a nutrition formula with arginine and omega-6 fatty acids can decrease the risk for complications dramatically, according to a meta-analysis looking at 3,104 patients across 28 randomized controlled trials. This type of supplementation, often referred to as immunonutrition, is associated with a 41% reduction in risk for infectious complications after elective surgery ((J Parenter Enteral Nutrr 2010;34:378-388).

“That’s the kind of game changer that we have been looking for,” said Dr. Flum.

Surgical experts not affiliated with the program said they expect surgeons will offer broad support for the initiative. Strong for Surgery will encourage patients to be more proactive about reducing their surgical risk, which should translate into better outcomes and better informed consent.

Modifiable factors that bear the greatest influence on outcomes are not always things like surgeon volume and operative times.

Rather, they are characteristics like smoking, nutritional status, glycemic control and medication use.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

rates: 25% with levels of 2.5 to 2.9 and 50% with levels of 2.0 to 2.4 g/dL. From there, the campaign will move on to the other modifiable factors like smoking, diabetes control, use of herbal preparations that can increase bleeding risk or anesthesia complications, and the use of medications like aspirin and β-blockers that patients may be taking chronically, said Richard P. Billingham, MD, clinical professor of surgery, University Tom Varghese Jr, MD, director of Strong for Surgery, a patient-centered approach to improving the health of patients in the pre-surgical clinic.

“Times have changed and cultures have changed. Now, patients know that they are an integral part of the operation and they, too, can contribute to better things happening to them rather than them just coming to the plate and asking to be taken care of,” said Julie A. Freischlag, MD, William Stewart Halsted professor and surgeon-in-chief, The Johns Hopkins Hospital, Baltimore.

“At the same time, we also feel empowered to tell people that there are things they need to do to. In the end, if we can get patients to do it, I think this will be a game changer.”

After being tested in a pilot project last year, Strong for Surgery is being rolled out to about 55 partner offices throughout Washington state for more testing.

SCOAP hospitals will report use of the different measures and organizers will use those results to develop a standardized checklist that can be integrated into every surgeon’s office. “'Strong for Surgery' takes the idea of checklists and moves them to where decisions are mostly being made, before the patient gets to the hospital,” said Dr. Flum. “There would never be an airplane that would start a checklist when it is already moving down the runway, and the same concept applies to surgery.

The doctor’s office is the last opportunity to have those important discussions about whether the patient is ready for an operation.”

In this next phase, pha the campaign will address the nutritional status of all patiients before surgery througgh implementation of nutritiional screening and use of evidence-based nuttritional support.

Results from SCOAP shoow that one marker of nutritional level (preeoperative albumin levelss) less than 3.0 g/dL are asssociated with higher postop perative complication

of Washington, and medical director for quality and education in colorectal surgery at Swedish Cancer Institute and Medical Center in Seattle. He will retire this winter after instituting the Strong for Surgery program in Swedish Hospital.

Dr. Billingham noted that important research questions must be answered before the nutrition program expands beyond the test hospitals. Much of the existing research was conducted with industry sponsorship and authorship.

“Therefore, the objectivity of the results is a little bit in question.” Investigators also need to assess the effectiveness of

nutritional supplements in the real world and their cost-effectiveness. Right now, patients pay about $60 for the immunonutrition supplements.

More information about the program is available at the Strong for Surgery website (http://www.becertain.org/ strong_for_surgery).

Strong for Surgery receives support from the ACS Division of Education, the Agency for Healthcare Research and Quality, the Life Sciences Discovery Fund and Nestlé HealthCare Nutrition. The latter does not provide funding to promote a specific product.

31

In the News POSTOPERATIVE PAIN jcontinued from page 1

technology (epidural, spinal or local blocks) with conventional treatment of pain (nonsteroidal anti-inflammatory drugs [NSAID] or morphine) and grouped them according to the surgical intervention. Many studies showed that local or regional anesthesia can prevent chronic pain after different surgical interventions, but a meta-analysis could only be performed if there was more than one study in a surgical subgroup.

The researchers found that thoracotomy patients have a lower likelihood of chronic pain at six months if they receive regional anesthesia instead of conventional pain control (odds ratio [OR], 0.33). This result comes from pooled analysis of 250 study participants. “An epidural … prevents pain six months down the road,” said Dr. M. Andreae, of the Department of Anesthesiology at Montefiore Medical Center/Albert Einstein College of Medicine, in New York City. “We were surprised to find the results were so clear; this is important because chronic pain after thoracotomy is so difficult to treat.”

The analysis of 89 patients who underwent surgery for breast cancer found that those who received a paravertebral block were less likely to experience pain five or six months postoperatively (OR, 0.37). Put another way, an epidural for thoracotomy or a paravertebral block for breast cancer surgery can prevent chronic pain in one patient for approximately every four to five patients treated. “Chronic pain can have a tremendous impact on quality of life; this is why prevention is paramount,” said Dr. Andreae. These and other findings were published Oct. 17, 2012, in the Cochrane

GSN Bulletin Board

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

‘Dr. Andreae’s review is extremely important in that it clearly demonstrates that chronic pain is reduced when regional anesthesia and analgesia are used, which is a very important argument for the widespread use of these techniques.’

—Arthur Atchabahian, MD Database of Systematic Reviews (2012, Issue 10. Art. No.: CD007105. doi: 10.1002/14651858.CD007105.pub2.).

“We as anesthesiologists have to become perioperative physicians and take a role in what happens after surgery,” Dr. Andreae said.

Dr. Andreae also has a message for surgeons.

“Chronic pain after surgery is underappreciated by surgeons, but it’s very important to the patient.” Some surgeons don’t realize pain can persist this far into the postoperative period, he added, or that prevention of pain with just a small amount of regional anesthesia can be very effective. “Even use of a single paravertebral block … or a single-shot intervention” can alleviate significant pain.

Simple infiltration of a wound before closure can be beneficial as well. “This doesn’t cost more and doesn’t increase [the rate of ] infection,” he added.

Many patients also need education, Dr. Andreae said. “When we tell them about a block, some say ‘just knock me out.’” Some patients may not understand how regional anesthesia works or—as this study points out— how it can be advantageous in the long run, he said.

“Dr. Andreae’s review is extremely important in that it clearly demonstrates that chronic pain is reduced when regional anesthesia and analgesia are used, which is a very important argument for the widespread use of these techniques,” said Arthur Atchabahian, MD, when asked to comment.

“A next step might be to evaluate possible long-term benefits from other modalities of acute postoperative pain control, such as multimodal pharmacologic analgesia,” said Dr. Atchabahian of the Department of Anesthesiology at New York University Langone Medical Center, in New York City. He was not affiliated with the current study.

The dichotomous responder analysis (patients either had pain or did not) made for a very clean study, “but chronic pain is a very complex concept that is not well captured by a yes/no answer,” Dr. Andreae said. Another potential limitation was the intermediate quality of the studies included in the meta-analysis, and the authors cautioned against overinterpretation of findings based on a small number of studies.

The investigators only included studies of adults. In the future, Dr. Andreae would like to assess chronic pain in children after surgery, as well as expand his current findings to another meta-analysis that assesses different types of surgical procedures.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

GSN-001-0213

32

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

AFFORDABLE CARE jcontinued from page 1

administration. This allowed the most comprehensive piece of medical legislation since Medicare to proceed.

The law is not what many of us, including the American College of Surgeons (ACS), hoped for. In fact, the ACS actually opposed it because of what it did not include, namely tort reform and a repeal of the sustainable growth rate (SGR), which potentially could result in a 30% slash in doctor’s fees for Medicare patients. (The SGR once again was given a temporary reprieve on Jan. 1, 2013.)

The legislation is not perfect by any means. What passage of this law did accomplish was to potentially give millions of uninsured and underinsured Americans access to our excellent health care system. It also is a step toward reforming a health care system that is unsustainable in the future. As I said in a previous editorial in General Surgery News (May 2010), we will need to remodel the law, but the ACA gives us a framework to change health care delivery. If it had not passed, I believe we would have squandered the possibility of reform for many more years.

The ACA also includes a new Patient’s Bill of Rights. Defeating the bill would have overturned a provision guaranteeing children’s pre-existing conditions, which are now covered. The ACA actually protects a patient’s choice of primary care doctor and access to the emergency room, and makes it easier for women to obtain OB/GYN consultations. These apply only to newer policies, but they do not interfere with grandfathered existing policies. But even the grandfathered health plans are prohibited from applying lifetime limits to key health benefits, are not allowed to cancel coverage based

on an honest mistake on your insurance application, and must extend dependent coverage to the age of 26 years.

Health insurance claims must use standardized procedures among insurance companies and streamline claim processing via electronic systems. This should result in faster reimbursement time. A very important provision is that the law limits the amount that your insurance company can spend on administrative costs to 15%. A little-known fact is that health insurance is exempted from antitrust laws and therefore, previously, your health care dollars went into a “black box”

with no accountability.

One of the most contentious political battles is raging over the Health Care Insurance Exchanges—regulated marketplaces where uninsured and small businesses can shop for coverage. States must declare whether they will form their own exchange, partner with the federal government, or have the federal government create and oversee the exchange. Maryland and 20 or so other states have chosen to form their own exchanges, but Tennessee and 27 other states, mostly based on the political party of the governor, see AFFORDABLE CARE page 34

Experience Surgical Innovation

at www.GeneralSurgeryNews.com

A little-known fact is that health insurance is exempted from antitrust laws and therefore, previously, your health care dollars went into a “black box” with no accountability.

What does the ACA do? An excellent website, www.healthcare.gov, explains the multiple features of the legislation that we all can understand. The number of papers that have been and will be written on the ACA will be staggering, as the new regulations are released and political bickering seeks to get in the way of implementation.

The massive document covers too many areas for me to address them all, so I will concentrate on several important sections.

The rights and protections include a requirement that language be succinct and understandable with a summary of benefits and coverage (SBC) and uniform glossary, a consumer assistance program, and a method for appealing health plan decisions. There is a focus on preventive care that eliminates copays for these services. (This applies only to jobrelated health plans and recently created insurance plans; some policies were “grandfathered in” and do not have this stipulation.)

Initial Operative Experience using LapFinger™

33

34

Opinion AFFORDABLE CARE jcontinued from page 33

have refused to form their own exchanges. These are legislated so that insurance companies can be compared easily, and information on various plans can be centralized, thus allowing patients to discriminate between plans. Some Republican governors have remained hostile to the idea of exchanges, but most appear simply to have wasted the time needed to prepare exchanges in the futile hope that the law would be struck down.

An area that does not directly involve surgeons is the formation of “medical homes.” These are team-based practices that incorporate mid-level practitioners (nurse practitioners and physician assistants), physical therapists, social services and primary care physicians into a “home” (a unit).

The rhetoric that the ACA will take $700 billion from Medicare over the next decade does not appear to have validity as the law is written. The Medicare-specific provisions include cost-free Medicare preventive services; removal of the “donut hole” gap in coverage for drugs; and more attention given to waste, fraud and abuse.

How well this will work, and if it can save rather than cost billions of dollars, is unknown.

Most importantly, this legislation does not adequately address cost control. Neither political party has said how this will be implemented.

The most well-known regulations involve increased coverage. A fine will be levied if an individual does not file for insurance. In Massachusetts, as of last month, more than 94% of its citizens were insured. Medicaid coverage for more individuals and families will include those with income levels less than 33% over the poverty level. The federal government has offered to fund 90% of this cost beginning in 2014 to 2016. Several state governors have said that they would not participate in Medicaid expansion, which potentially will cost their states billions in new Medicaid money in the near future. However, the Supreme Court made the Medicaid expansion at a state level “optional,” so this issue will be unsettled for some years to come. The government was not allowed to tie the new legislation to existing Medicaid payments.

There is a series of regulations and subsidies for small businesses to ensure that they contribute to the cost of their employees’ health insurance. Businesses

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2013

with more than 50 employees must comply by 2014 to provide insurance or face fines. Small businesses with fewer than 25 employees who make an average salary less than $50,000 get a taax credit of 50% of costs of coveraage, which will be phased out over 10 years. Some small businesses will take the fine rather than pay for fo insurance, while others fear that hat the additional cost will hinder their ability to expand.

There is a provision for Medicare Physician Quality Reporting Initiative (PQRI). It is a voluntary initiative; however, payments will be reduced for nonparticipation by 2015, along with incentive payments of 1% in 2011 and 0.5% from 2012 to 2014.

A sticking point for many doctors, including the ACS, is the Medicare Independent Payment Advisory Board, an appointed group that will make recommendations on funding. Although physicians are part of the board, they will be appointed by the government. How powerful this group will be is unknown.

Another advisory group is the Patient Centered Outcomes Research Institute (PCORI) to advise federal agencies. This group of appointees is supposed to do comparative effectiveness research, but is prohibited from developing or using cost/ QALY (or quality-adjusted life-years) thresholds. Whether this will be a group to determine practice is unknown.

What the ACA is not is a universal coverage system or a single-payer system. It is not solely government-run, does not remove employer-based insurance, and does not set insurance premium levels or medical provider rates. Because of the fear that paying doctors to talk to patients about end-of-life issues would result in “death panels,” that legislation was removed. Most importantly, this legislation does not adequately address cost control. Neither political party has said how this will be implemented.

There are several other problems that we face in surgery. There is an upcoming manpower shortage that we will be facing in medicine, and in general surgery in particular. Graduating only 1,100 residents a year, a number mandated under the Balanced Budget Act (BBA) of 1997, is about to create a significant shortage of general surgeons and other surgical specialties (urology, thoracic) in the next several years. More than 80% of current graduates are entering fellowships now, which leaves only 200 or so of the 1,100 graduating surgeons who are calling themselves general surgeons at the end of residency.

The Accreditation Council for Graduate Medical Education, the ACS, the Association of American Medical

College leges, and the Macy Foundation all agree that we need the government to help sponsor more residency slots. How tthis will be funded an nd what the rules for expansion will be are yet to be determined. ye The Physicians FounT dation (Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill) under Tom Ricketts, MD, and George Sheldon, MD, has been a strong advocate for increasing the number of general surgeons. The Institute of Medicine has expounded on this very topic (Projectiles and Projections:"Sufficiency of Physicians and Graduate Medical Education," updated Dec. 26, 2012) and hopefully there will be support to increase the number of surgery slots for our medical students.

Finally, tort reform is still a thorny issue, which is being handled well at a state level, but does not have enough support in Congress to make it a “fall-onmy-sword” issue for either party or the

president. It is much easier for surgeons and other physicians to influence their state legislatures than to try to crank the rusty wheel of Capitol Hill.

Obviously, a myriad of other problems exists, including a new era in training dominated by the 80-hour workweek, the fact that more than 50% of surgeons in the United States are now employed while the individual practitioner is becoming a historical figure. Fee-for-service is in danger, and we all have to fight the increased health care costs at a time when technology is driving us to more expensive, but not necessarily safer technology (robots, single-port surgery, CAT scans as admission criteria, PET scans for every cancer).

I leave the discussion on these topics to another day. Meanwhile, we must realize that singer Bob Dylan was right that “the times, they are a-changing,” and as technology expert and author Daniel Burrus once said, “The future isn’t what it used to be.” We still have an opportunity to lead the way, or we can take the role that some of our colleagues have suggested and retreat to Ayn Rand’s Colorado. The choice is up to us.

—Dr. Reines is Vice Chairman, Inova — Health System, Falls Church, Virginia.

SURGEONS’ LOUNGE jContinued from page 33

significant diameter of the lumen and long-segment strictures are unlikely to resolve with this therapy. Gastrogastric fistulae are sometimes amenable to closure through endoscopic techniques, but if a revisional procedure is planned, more definitive surgical division and closure may be appropriate.

A surgical revision for this patient would include creating a new, smaller pouch while maintaining appropriate blood supply; resecting the distal pouch and gastrojejunal anastomosis; and fashioning a new anastomosis that is tension-free and that allows for dependent drainage from the pouch.

A hand-sewn anastomosis with nonbraided suture material (absorbable inner layer and nonabsorbable outer layer) will help to avoid the inflammatory reaction that can lead to strictures and ulcers. If a gastrogastric fistula is present, this must be divided, and a partial remnant gastrectomy may be advisable to avoid recurrence.

If possible, revisional surgery is accomplished through a minimally invasive technique, depending on the skill and experience of the surgeon. In general, revisional surgery has higher morbidity and mortality rates than primary bariatric surgery, but a laparoscopic approach can help to minimize complications.

Suggested Reading Azagury DE, Abu Dayyeh BK, Greenwalt IT, Thompson CC. Marginal ulceration after Roux-en-Y gastric bypass surgery: characteristics, risk factors, treatment, and outcomes.

Endoscopy. 2011;43:950-954.

Bhardwaj A, Cooney RN, Wehrman A, Rogers AM, Mathew A. Endoscopic repair of small symptomatic gastrogastric fistulas after gastric bypass surgery: a single center experience.

Obes Surg. 2010;20:1090-1095.

Patel RA, Brolin RE, Gandhi A. Revisional operations for marginal ulcer after Roux-en-Y gastric bypass.

Surg Obes Relat Dis. 2009;5:317–322.

Racu C, Mehran A. Marginal ulcers after Roux-en-Y gastric bypass: Pain for the patient … pain for the surgeon. Bariatric Times. 2010;7:23-25.

The bookstore division of

MCMAHONMEDICALBOOKS.COM An Online Bookstore

ORDER BOOKS ONLINE

THE BOOK PAGE PUBLISHER’S TOP PICKS OF THE MONTH ON MCMAHONMEDICALBOOKS.COM These books and thousands more...

1

1

2

3

4

5

6

7

8

ACS Collection 7: Trauma Various Authors

2003

Blunt and penetrating trauma are leading causes of serious injury and death. Motor vehicle accidents, violence, war and disasters continue to create unnecessary casualties. The current situation of emergency preparedness and heightened security have made care of the trauma patient more critical than ever.

Scan here for our complete catalog of medical books.

ORDER ONLINE For pricing, a more complete review and easy ordering with a credit card, go to McMahonMedicalBooks.com.

We can supply any medical book in print, so if you don’t find the book you want, email your request with billing information to RMcMahon@McMahonMed.com.

If you are an author and would like your medical book featured in this book section, contact Ray McMahon, Publisher, at RMcMahon@McMahonMed.com.

2

Acute Care Surgery

LD Britt; Andrew Peitzman; Phillip Barie; Gregory Jurkovich June 4, 2012 Acute Care Surgery y is a comprehensive textbook covering the related fields of trauma, critical care and emergency general surgery. Each chapter highlights cutting-edge advances. An evidence-based approach is emphasized for all content included. Also, notable controversies are discussed in detail, often accompanied by data-driven resolutions.

3

Aphorisms & Quotations for the Surgeon

Edited by M Schein February 15, 2004 This book presents a medley of more than 1,500 aphorisms, quotations and rules—by surgeons and nonsurgeons—about surgery, surgeons and anything relevant to the practice of surgery.

4

Handbook of Colorectal Surgery: Third Edition

David Beck September 30, 2012 Completely revised and expanded to include technological advances, the third edition of this text illustrates key anatomical structures, examination procedures and surgical techniques for proper diagnosis, management and treatment of patients with colorectal disorders, providing extensive coverage of various methods in preoperative preparation and assessment, pain management, sedation and wound care for conditions such as ulcerative colitis, Crohn’s disease, diverticulitis and colorectal ca c o a carcinoma.

5

Jaypee’s Video Atlas of Shoulder Surgery

Peter D. McCann April 30, 2013 The Video Atlas of Shoulder Surgery y is the most comprehensive and authoritative collection of video and written text about shoulder procedures currently available in one volume, authored by orthopedic surgeons internationally recognized as experts in the field of shoulder surgery.

6

Maingot’s Abdominal Operations, 12th Edition

Michael J. Zinner, Stanley W. Ashley November 12, 2012 Presented in full color for the first time, the 63 streamlined chapters of the twelfth edition of this authoritative resource offer a concise, yet complete, survey of the diagnosis and management of benign and malignant digestive diseases. It has everything you need to understand congenital, acquired and neoplastic disorders—and optimize surgical outcomes for any type of abdominal procedure.

7

Surgeon Stories

Daly Walker April 19, 2011 For many of us, the physician-surgeon has been the body’s personal champion and sometimes savior in the face of disease, accident, aging, human violence and war. While most of these categories of threat are inevitably faced by all of us, war is the ultimate ogre, and its ravages dwarf and challenge even the most skilled physician.

8

Trauma, Seventh Edition

Kenneth Mattox; Ernest Moore; David Feliciano September 28, 2012 Now in its seventh edition, Traumaa reaffirms its status as the leading comprehensive textbook in the field. With a new full-color design and a rich atlas of anatomic drawings and surgical approaches, this text takes you through the full range of injuries the trauma surgeon is likely to encounter. The book also features timely coverage that explains how to care for war victims who may require acute interventions such as amputation. p GSN0213

The LigaSure™ Small Jaw Instrument is now cleared for ENT in the US

LigaSure™ Small Jaw Sealer/Divider Designed for Open Surgery For consistent, controlled tissue effect, surgeons choose the industry standard LigaSure™ technology with proprietary TissueFect sensing. The LigaSure™ small jaw instrument, energized by the ForceTriad™ energy platform, is used in general, plastic/reconstructive, urologic and thoracic procedures. The device is now cleared for ENT in adults.

Scan the QR code or visit Covidien.com/SmallJaw to see how it compares to the Harmonic FOCUS™* COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. TM* Trademark of its respective owner. Other brands are trademarks of a Covidien company ©2012 Covidien. 11.12 M121010a

t Low temperature profile t Multifunctional t Easy to use