The November 2012 Digital Edition of General Surgery News

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40th Anniversary 1972-2012

GENERALSURGERYNEWS.COM

November 2012 • Volume 39 • Number 11

The Independent Monthly Newspaper for the General Surgeon

In the News

Radiofrequency May Be Alternative To Radiation After Breast Excision

Multispecialty Corner

Therapy for Barrett’s Esophagus:

What, When and in Which Patients?

That Depends on Whom You Ask: General Surgeons, Thoracic Surgeons and Gastroenterologists Give Their Perspectives

B Y M ONICA J. S MITH PHOENIX X—The combination of excision and radiofrequency ablation (eRFA) of the lumpectomy site at the time of surgery may reduce the need for further operations and provide an inexpensive and accessible alternative to radiation therapy for breast cancer, according to research presented at the 2012 meeting of the American Society of Breast Surgeons (ASBrS).

‘The fact is it’s more important what I left behind than what I took out.‘ “Margin activity is the only prognostic factor that surgeons can affect,” said Misti Wilson, MD, University of Arkansas for Medical Sciences (UAMS), in Little Rock. “Studies have shown that [the] margin factor is the strongest predictor of local recurrence, which can range from 7% with negative margins to 27% in positive margins. But even with our best efforts, 20% to 40% of patients require re-excision for close or positive margins.”

The biggest obstacle to achieving negative margins is that there is no way for a surgeon to be certain that he or she has attained that goal at the time of surgery, explained V. Suzanne Klimberg, MD, Muriel Balsam Kohn Chair in breast surgical oncology, UAMS, and president of ASBrS. see RADIOFREQUENCY page 22

®

Within Three Days May Be W O Optimal, According to Study

B Y M AUREEN S ULLIVAN

O

ver the past decade, n new advancements in ablatioon therapy have expanded treat-ment options for patients with Barrett’s esophagus (BE).

Introduced to clinical practice in 2005, radiofrequency ablation (RFA) is one of the most recent ablation techniquess available for the treatment of th his disease and is widely used in the medical community.

Although studies are now em merging that provide evidence of the medium-term effectiveness of RFA, RFA controversy exists among medical see BARRETT'S ESOPHAGUS page 16

B Y J AMES E. B ARONE , MD

Endoscopic mucosal resection for Barrett’s esophagus.

Courtesy of Prasad G. Iyer, MD, Mayo Clinic.

Benefits of SILS and NOTES as Bariatric Procedures Still Unproven Desire To Push the Envelope Needs To Be Balanced With Safety B Y M ONICA J. S MITH SAN DIEGO—The use of natural orifice translumenal endoscopic surgery (NOTES) and single-incision laparoscopic surgery (SILS) as techniques in bariatric surgery are still largely experimental and controversial, according to Ricardo Zorron, MD, PhD,

When Is Best To Operate on A Small-Bowel Obstruction?

director, Innovative Surgery Division, Klinikum Bremerhaven Reinkenheide, Bremerhaven, Germany.

Speaking at a session on innovations in obesity and metabolic surgery at the 2012 meeting of the Society of

“Never let the sun to rise or set on a small bowel obstruction.”

Although these words were written more than 100 years ago, some surgeons still believe them.

But recent studies show that about B 775% of patients with a small-bowel obstruction will get better without surggery. So how many sunsets should you wait to operate?

A paper presented at the 2012 annual m meeting of the American Association for tthe Surgery of Trauma suggests that surgeons probably should wait no longer than three days.

In an email to General Surgery News, senior author Frederick H. Millham, MD, chair, Department of Surgery, Newton–Wellesley Hospital, in Newton, Mass., and associate professor of surgery at Harvard Medical School, in Boston, said, “[Small-bowel obstruction] is a complex problem. Some patients need surgery right away; some need it eventually; and some don’t need it at all. The first group tells us they see SMALL BOWEL PAGE 8

REPORT Clinical Experience Using Multifunctional LigaSure™ Small Jaw Instrument in Vessel Sealing Procedures

see BARIATRIC SILS page 25

see insert at page 16

INSIDE In the News

Surgeons’ Lounge

Letters

Early Surgery for Acute Cholecystitis Leads to Shorter Hospital Stays .................. 4

Analgesia care following reconstructive thoracic surgery after tumor extirpation ....................... 18

ER Call, Beeper Anxiety and Credit Ratings: Surgeons Voice Views on Recent Opinion Article .... 24

SIGNIFICANTLY

REDUCES SSI Rate of Superf icial Incisional SSI Alexis速 Wound Protector/Retractor

22.7% (15/66)

Standard Retractors

P = 0.004

14.6% (7/48)

79%

P = 0.02

P = 0.0021

89%

RRR*

RRR*

8.1%

100% RRR*

(9/110)

4.69% (3/64)

1.6% (1/61)

0%

(0/111)

Lee, et al. 2

Reid, et al. 1

For more information, please visit

Horiuchi, et al. 3

Scan to request a clinical study booklet or contact from a representative.

www.appliedmedical.com or call 800.282.2212

速

WO OUND PROTECTOR/RETRACTOR Medical, the Applied Medical logo and Alexis are U.S. registered tradem marks of Applied Medical Resources Corporation. 1917AL1012

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Great News for Chocolate Lovers Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

I recently came across a report that supported my infatuation with chocolate and corroborated all those delicious cravings that I, and most likely you, have had for this wonderful flavonoid. Now there is good scientific support that flavonoids, and especially the subclassification called flavanols, are great for enhancing cognitive function. These flavanols are found in cocoa and other foods such as red wine and green tea. They can reverse loss of cognitive function associated with aging.

The aging piece really got my attention!

Although I have not been a devotee of green tea, I do like red wine. It is nice to know that brain function and cardiac performance may be helped by occasionally imbibing a good Merlot. I am really excited that chocolate intake can add to mentation, and retard brain degeneration. This exciting revelation could be used in a variety of ways for

all of us while also substantiating what I have known intuitively—that chocolate is a great food group!

Think of it. Along with our daily calcium, aspirin, multivitamin, and so on, a nice piece of dark chocolate will really be beneficial. Perhaps if we begin frequent chocolate consumption at a young age, the levels of educational testing in U.S. children will improve greatly and we will catch up with testing scores in other non-U.S. cultures. By increasing cognitive function in our children, more young people will have the grades and testing ability to go to college and eventually attend medical school. The chocolate effect will eventually help to close the workforce gap, especially in surgery since—hopefully—bright children initiating significant chocolate consumption at an early age will gravitate toward general surgery. The cognitive versus noncognitive dichotomy spawned by our internal medicine colleagues also will be laid to rest forever!

Think of all the possibilities for using the “chocolate phenomenon� as a predictor of success in medical school and residency. Rather than depending on MCAT,

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

USMLE Steps 1 and 2 test scores, the consumption of flavonoids and flavanols could be assessed as indicators of success and potential. Prior to in-service exams and the boards, our young surggical colleagues should in n crease their daily chocc olate consumption, en n suring impressive passs rates across the spectrum m. We could arrange for a plentiful l f l supply l off chocolate to be available in the operating room lounge and cafeterias so that we and our trainees would never have to be wanting for this important food group.

The entire approach to geriatric medicine will be revolutionized when those who are younger than Medicare age begin ingesting chocolate in all forms. Maybe this will be a counter to the changes in Medicare eligibility potentially created by the recent election results. Hopefully the incidence of dementia will fall significantly. Operative outcomes for older populations will be enhanced by witnessing a reduction in postoperative cognitive issues and delirium, especially in the ICU.

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Peerhaps rather than jusst assessing preoperative aalbumin levels, the serum fl flavanoll llevell will give more reliable data regarding the ability of the octogenarian to have a smooth postoperative course.

I hope that you are as excited about this story as I am. As we see a continued push to reduce the ingestion of sugar-laden foods and sodas by our legislative colleagues, we must stand up for our rights as chocolate lovers and make everyone aware of the benefits of cocoa, fudge, dark chocolate and the like, and continue to add to the existing research base that extols the virtues of this important food group. Who knows? I might eventually give up coffee and drink hot chocolate.

That probably is a stretch!

Joseph J. Pietrafitta, MD

Michael Kavic, MD

Long Branch, NJ Laparoscopy, Telemedicine

Rather than depending on MCAT, USMLE Steps 1 and 2 test scores, the consumption of flavonoids and flavanols could be assessed as indicators of success and potential.

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

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INFECTIOUS DISEASE SPECIAL EDITION

3

4

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Early Surgery for Acute Cholecystitis Leads to Shorter Hospital Stays B Y J AMES E. B ARONE , MD

M

ost surgeons agree that patients with acute cholecystitis should have surgery during their initial hospitalization—the so-called early cholecystectomy. But the definition of “early” has been debated. Surgeons from Duke University, in Durham, N.C., tried to clarify this issue in a paper presented at the 2012 annual meeting of the American Association for the Surgery of Trauma (AAST).

The researchers found that postponing surgery just one day after admission resulted in a significantly longer hospital length of stay (LOS). A preoperative stay of two or more days produced longer operative times, and patients were significantly more likely to need open cholecystectomy. Patients undergoing cholecystectomy after three or more preoperative hospital days had significantly longer postoperative and hospital stays. However, the number of preoperative days did not affect 30-day morbidity and mortality.

In an email to General Surgery News, author Mark L. Shapiro, MD, wrote, “Our group concluded that early or immediate cholecystectomy was justified, safe and more efficient than delaying the procedure.”

This study was based on data from the National Surgical Quality Improvement

AT A GLANCE Postponing surgery just one day after admission resulted in significantly longer hospital length of stay.

The study showed that reducing length of stay by even one day would save a significant amount of money, if extrapolated to all patients having surgery for acute cholecystitis.

The study was subject to all the shortcomings of other studies that use NSQIP data, such as missing clinical information and the failure to capture all relevant cases.

Project (NSQIP) for the years 2005 to 2010, for emergency cholecystectomy.

The study included 5,268 patients, with nearly 50% of these patients undergoing cholecystectomy on the day of admission and 33% having surgery on the following day. Two preoperative days were noted in 498 patients (9.5%), three days in 204 patients (3.9%) and four or more days in 189 patients (3.6%).

There were 1,620 high-risk patients, defined as those with a preoperative acute medical condition, preoperative septic shock, age 65 years or older, or an American Society of Anesthesiologists (ASA) score of 4 or higher. These patients had their operations significantly later than those without high-risk factors, but preoperative LOS did not affect morbidity, mortality, operative duration or the need for open surgery. For highrisk patients, a preoperative stay of four or more days led to significantly longer postoperative and hospital lengths of stay.

The study showed that reducing the LOS by even one day would save a significant amount of money if extrapolated to all patients having surgery for acute cholecystitis.

Surgeon Joins General Surgery News James E. Barone, MD, FACS, FCCM, has joined General Surgery News as a medical reporter. Dr. Barone, from Stamford, Conn., is board-certified in general surgery and surgical critical care.

He was a surgical department chairman and residency program director for 24 years, and currently works as an acute care surgeon and surgical hospitalist. In the past year, Dr. Barone has written more than 50 articles for Reuters Health. This issue features two of his articles— reports from the recent annual meeting of the American Association for the Surgery of Trauma (pages 1 and 4).

timing of operation would be excessive The Duke group does not have a given the number of patients that would strict treatment protocol in place for need to be enrolled in order to adequate- these patients, but Dr. Shapiro believed ly power such a study. Our analysis gives that a 24-hour service for handling every indication that performing the patients with acute cholecystitis with operation early is safe and that it is asso- surgery on the day of admission should ciated with significant potential societal be the goal, while acknowledging the cost advantages.” challenges in providing such a service.

Regarding the management of patients “A balance must be struck between with acute cholecystitis and serious med- efficiency, safety and good old comical comorbidities, Dr. Shapiro said, mon sense,” he said. “For instance, how “Patients in whom operation within the many hours has the operating room first few days of admission is and its staff been struggling through “The paper supports my deemed too risky might be bet- the night? How many hours and cases ter managed with a percutane- have the surgeon and the anesthesiolobias and is another nail ous cholecystostomy tube.” He gist been toiling through?” in the coffin of delayed added that a comparison of “I think the question of doing chosame-day admission cholecyslecystectomy in the first 72 hours verintervention.” tectomy versus percutaneous sus later in the hospitalization has been —Nathan T. Mowery, MD cholecystostomy tube place- answered,” Dr. Mowery said. “Addiment and interval cholecystec- tional prospective data are needed to Nathan T. Mowery, tomy would be an interesting study. know when exactly in that 72 hours MD, assistant professor of surgery, Wake “We have tried to treat night and day it can safely be done. One advantage Forest Baptist Medical Center, in Win- as the same and post these cases whenev- of the acute care surgery model is the ston-Salem, N.C., was the invited discus- er they present,” Dr. Mowery said. “That ability to intervene very early in that sant for the paper at the AAST meeting. means the vast majority of the chole- 72-hour window.”

“The paper supports my bias and is cystectomies we do urgently happen another nail in the coffin of delayed between 5 p.m. and 7 a.m.” intervention,” he told General Surgery News, although he pointed out that the Correction: study was subject to all the shortcomA table in the article "Sleeve Gastrectomy Gets Parital Green-Light Coverage from ings of other studies that used NSQIP CMS" in the Sept 2012 issue, pages 22 and 36 contained an error. The following is data, such as missing clinical information the corrected table. and NSQIP’s failure to capture all relevant cases.

The authors acknowledged some limTable. Key End Points of Study From the Bariatric Outcomes Longitudinal itations of their study. The time that Databasea symptoms began and the studies used to make the diagnosis of acute cholecystiGastric Gastric Sleeve tis were not available. Causes of delays, Bypass, % Banding, % Gastrectomy,% such as difficulty establishing the diag30-day serious 1.25 0.25 0.96 nosis, could not be determined. Time of complication rate day of the admission, which could have influenced the decision about when to Death rate 0.14 0.03 0.08 schedule the emergency procedure, also Weight loss 40 20 30 was unknown. (% BMI lost) Dr. Shapiro considered the matter settled and said, “The cost to perform a ranBMI, body mass index a domized trial showing ‘no difference’ in Presented at the 2012 annual meeting of the American Society of Metabolic and Bariatric Surgery

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6

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Infrared Thermography Falls Short Compared With Mammography B Y M ONICA J. S MITH PHOENIX—Dashing hopes that infrared thermography could help distinguish malignant from benign lesions on imaging studies, research presented at the 2012 meeting of the American Society of Breast Surgeons suggests the noninvasive, radiation-free exam is not a useful tool for breast cancer screening.

“We recognize that we see a lot of

false-positives with mammography and that we do a lot of unnecessary biopsies, but we need to detect all the cancers we do; we don’t want to miss any,” said lead investigator Andrea Barrio, MD, FACS, a breast surgeon at Bryn Mawr Hospital, in Philadelphia.

Infrared thermography is of great interest to patients attracted to the possibility of a noninvasive screening method that does not involve radiation.

“We get questions weekly by patients who ask, ‘can I get this done instead?’”

Dr. Barrio said. “Many centers use it adjunctively.”

If their study had found infrared thermography useful, Dr. Barrio and her colleagues saw a role for it not in place of, or as an adjunct to, mammography, but to avoid biopsy in situations where a patient had an imaging abnormality but a negative NoTouch BreastScan (UE

LifeSciences; NTBS), using the name of the product in the study.

“We could say to them, ‘if your infrared is negative, then we can just watch these calcifications because we’ve never found a negative infrared in someone with cancer,’” Dr. Barrio said. “But it didn’t pan out that way.”

Since the 1982 FDA approval of an infrared device as an adjunctive tool for breast cancer screening, many such devices have been approved for that purpose. They are based on the concept that a breast harboring cancer will be warmer than a normal breast due to the angiogenesis required to sustain a tumor.

The subject of Dr. Barrio’s study, the NTBS uses dual infrared cameras and computer analysis to detect differences in blood flow that might show up as temperature differences, comparing breast surface thermal abnormalities and asymmetries.

The institutional review board– approved, nonrandomized trial consisted of 181 patients with 187 imaging abnormalities on mammography, ultrasound or magnetic resonance imaging, all of whom received an NTBS prior to minimally invasive biopsy. The researchers then compared tissue pathology with NTBS results.

The study was originally set to a higher specificity mode in an attempt to minimize false-positives, but when the researchers did a midterm analysis of the data in 2010, they recognized that the sensitivity was too low to detect cancers, so they shifted to a higher sensitivity mode.

Of the 178 patients evaluated in the prospective portion of the trial, 50 patients had 52 positive breast biopsies and 128 had 132 negative biopsies. In the higher specificity mode, NTBS was positive in only 26 patients. The normal contralateral breasts were scanned too, with a positive finding in 24%.

In the higher sensitivity mode, a retrospective evaluation, 22 more patients were excluded due to uninterpretable scans. Of the 156 remaining, 44 patients had 42 positive breast biopsies and 112 had 116 negative biopsies. Of the 46 positive biopsies, 40 had a positive NTBS, for a sensitivity of 87%.

“Unfortunately, this led to a dramatic decrease in specificity,” Dr. Barrio said, noting NTBS identified 47% of the contralateral breasts as positive this time.

“Our conclusion is that NTBS thermography was unable to discriminate between benign and malignant lesions in

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

“The promise of thermography is that it can give an idea of the activity of breast tissue without exposing the patient to radiation. ‌ Unfortunately, the results just do not hold up.â€? —Deanna J. Attai, MD women with suspicious imaging abnormalities in the low specificity mode.

When we went to the higher sensitivity mode, it still missed about 13% of the cancers and resulted in an unacceptable number of false-positives,� Dr. Barrio said.

Another issue is that NTBS does not pinpoint an area in the breast; it merely identifies that one breast is warmer. “It’s a functional scan, not a structural one, so it does have some problems.

If you have one breast that’s hotter than the other, how far do you go in looking for an abnormality while being aware of the high number of false-positives that exist?� Dr. Barrio said.

The maker of the NTBS, who is from India and envisions his invention being used to identify women who should undergo further screening in places where mammography is rare, thought the 87% sensitivity was good, Dr. Barrio reported. “And it is, but that’s 87% as sensitive as a mammogram. It was concerning to us

that it missed that percentage of cancers and that the false-positive rate was high.�

The findings were disappointing to Dr. Barrio’s team, and certainly to many others. “Out here in Los Angeles, and I’m sure in many other areas of the country, this is a hot topic among patients, especially given some of the studies raising concerns about radiation exposure from imaging tests,� said Deanna J. Attai, MD, Center for Breast Care, Inc., in Burbank, Calif. “The promise of thermography is that it can give an idea of the activity of breast tissue without exposing the patient to

radiation—amazing. Unfortunately, the results just do not hold up,� Dr. Attai said. “While we all recognize that mammography has limitations, especially in younger women and in women with dense breast tissue, at this point it is still the best overall screening test that we have.�

The sun has not completely set on infrared thermography, however. Dr. Barrio’s group also conducted NTBS on a number of women at high risk for breast cancer, those with a family history or atypia on a past biopsy, to see what happens down the road. At this point, these women do not have imaging

abnormalities, but the researchers are investigating the possibility that even if infrared thermography fails to detect present tumors, it may be able to warn about future cancers. “We hope to look over time to see, if they had an abnormal infrared, did [the infrared] predict anything for the future, and if they do develop a cancer in that time period, what did their infrared look like when we first screened them,� Dr. Barrio said. “I don’t know that we’ll have an answer to that anytime soon, but it will be something interesting to look out for.�

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AT A GLANCE Infrared thermography is based on the concept that a breast harboring cancer will be warmer than a normal breast due to the angiogenesis required to sustain a tumor.

NTBS [NoTouch BreastScan] thermography was unable to discriminate between benign and malignant lesions in women with suspicious imaging abnormalities in the low specificity mode.

Another issue is that NTBS does not pinpoint an area in the breast; it merely identifies that one breast is warmer.

7

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8

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Health Benefits of Gastric Bypass Surgery Persist for Six Years Long-Term Follow-up Unseen in Many Other Studies B Y G EORGE O CHOA

T

control groups: Control group 1 consisted of participants seeking RYGB surgery who did not have surgery (n=417), and control group 2 was a population-based sample without prior history of bariatric surgery (n=321).

In control group 1, said Dr. Adams, “most [patients] did not have the surgery because their insurance company wouldn’t cover the procedure.”

At six years, 92.6% of the surgical group had follow-up data, compared with 72.9% of control group 1 and 96.9% of control group 2.

“Ninety-twoo percent follow follow-up up is very good—way beyyond what we can usually get,” said d Jaime Ponce, MD, FACS, FASMBS,

he health benefits of Roux-enY gastric bypass (RYGB) surgery in severely obese patients persist for six years, according to a prospective, controlled study (JAMA ( A 2012;308:11221131). These benefits include weight loss and improvements in major cardiovascular and metabolic risk factors.

Previous studies reporting long-term weight loss after bariatric surgery had been limited and often with incomplete follow-up, reported the authors.

“I think the most important aspect of this paper is its long- ‘The cost of caring for term nature,” lead author Ted D. the average patient Adams, PhD, MPH, program director, Health and Fitness Instiwith diabetes is tute, Intermountain Healthcare, $6,000 to $8,000 a year.

Salt Lake City, said in an interview.

Dr. Adams, who is also principal In two and a half years, research investigator, Cardiovasyou would have paid for cular Genetics, University of Utah School of Medicine, Salt Lake City, the surgery cost. … [The added, “This is the largest and longest exclusive gastric bypass study to study] sends a message to date.” insurance companies The study included 1,156 severely obese (body mass index [BMI] when they’re denying ≥35 kg/m2) participants aged 18 to coverage.’

72 years. The study included 418 patients treated with RYGB. These —Jaime Ponce, MD patients were compared with two

SMALL BOWEL jcontinued from page 1

need surgery. It’s challenging to try to distinguish the second group from the third in some cases. We need to figure out where to draw the line.”

Dr. Millham and his group reviewed the Nationwide Inpatient Sample for 2009. It is a large database sponsored by the Agency for Healthcare Research and Quality and contains information from 44 states. Patients undergoing gynecologic procedures and those in the category of early postoperative small-bowel obstruction were excluded. There were more than 27,000 patients with adhesive small-bowel obstruction, with some 4,800 patients (18%) who underwent surgery for this condition.

The main outcomes studied were complications, number of resections, deaths and postoperative length of stay (LOS) longer than seven days. The ages of the patients were similar in the nonoperative and operative groups, but the average LOS was three days longer for those who had surgery (P<0.001).

About 60% of the patients managed nonoperatively were discharged by the end of day 3, with 91% discharged by the end of day 7.

Women comprised 60% of those admitted with a small-bowel obstruction and 66% of those who had

president, American Society for Metabolic and Bariatric Surgery, Gainesville, Fla., who was not associated with the study.

In the surgical group, mean unadjusted weight loss from baseline to year 6 was 27.7% (95% confidence interval [CI], 26.6%-28.9%). In control group 1, weight gain over that period was 0.2% (95% CI, –1.1% to 1.4%) and in control group 2, it was 0% (95% CI, –1.2% to 1.2%).

The diabetes remission rate six years after surgery was 62% in the surgical group compared with 8% in control group 1 and 6% in control group 2. The incidence of diabetes during the six-year follow-up period was low wer in the surgery group, at 2%, com mpared with control groups 1 and a 2 at 17% and 15%, respecttively.

Metabolic and cardiovascular risk prrofiles at six years were signifficantly improved after RYG GB. For example, compared d with the control groups, th he surgery group had a decrease in n fasting glucose, an increase in high h-density lipoprotein cholesterol levvels and improved remission rates of h hypertension.

“There are threee take-home messages,” Dr. Adam ms said. “One, dramatic weight lloss at two years was pretty well maintained at six years. Two, patients who had h health problems and had su urgery showed a general improvement i in their coondition, such as

surgery (P<0.001 for both). The authors speculated that more women required surgery because of pelvic adhesions that probably do not resolve as easily as generalized abdominal adhesions.

Patients who underwent surgery usually had their operations within the first few days, with 80% having had surgery by the end of the third day of admission.

For the patients having surgery, 19% experienced complications; 25% required resection of intestine; 3% died; and 32% stayed longer than seven days in the hospital postoperatively. A delay of four or more days until surgery resulted in a complication rate of 25%, a resection rate of 28% and a mortality rate of 5%, with 43% of patients hospitalized longer than seven days after surgery.

All of these differences were statistically significant compared with earlier surgery. But after multivariate analysis, only the risk for death (increased by 60%) and postoperative LOS longer than seven days remained significantly related to delaying surgery.

Invited discussant Rao R. Ivatury, MD, chair, Division of Trauma, Critical Care and Emergency Surgery at Virginia Commonwealth University, in Richmond, asked Dr. Millham if he could explain why the delayed group had a higher mortality rate considering that the rate of resection was similar.

Dr. Millham said that it was possible that there was

diabetes being remitted. Three, those patients who didn’t have a health problem, such as diabetes, were less likely to develop it after surgery.”

“It’s very relevant,” Dr. Ponce said.

“There were tremendous benefits with the surgical group. The control groups showed if you don’t do surgery, the patients will continue to have diabetes.

The longer you leave it alone, the more problems you’ll have.”

Dr. Ponce also noted the vast economic savings that could be realized with bariatric surgery. “The cost of bariatric surgery is about $20,000. The cost of caring for the average patient with diabetes is $6,000 to $8,000 a year.

In two and a half years, [with diabetes in remission,] you would have paid for the surgery cost. … [The study] sends a message to insurance companies when they’re denying coverage.”

The study’s major limitation, said Dr. Ponce, is that it was not randomized.

“There may be a little bit of bias, but it’s probably minimal.”

Dr. Adams said that a 10-year follow-up study is planned. Of concern are psychosocial factors and the increased incidence of suicide in the surgical group. “The numbers of suicides were small, but nevertheless it’s a flag,” said Dr. Adams.

The study was funded by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.

a bias toward higher physiologic acuity in the early surgery group, due to the large percentage of that group who underwent surgery on the day of admission.

“When the early and delayed [surgery] groups are compared, the patients in the early group may mask the patients in the delayed group who physiologically deteriorated,” he said.

Dr. Millham acknowledged a few limitations of the study. For one, physiologic data and the indications for surgery were not available in the National Inpatient Sample, which is composed of administrative data only.

“It is possible that the lack of effect of delay on resection results from the high resection rate in patients operated on at the time of admission,” he said.

Also, a possible increase in the percentage of resections in the delayed group might not be readily apparent in the data. Dr. Millham saw this study as hypothesis-generating and thought a prospective study that included indications for surgery would sort this out.

“We can definitely say that patients stay longer and are more likely to die with delay, but are left looking for additional data,” Dr. Millham said. “I hope this work will stimulate a multicenter trial to get a better answer.”

Dr. Ivatury echoed this and said, “I agree that these answers cannot come from a large database but from a multicenter, prospective study.”

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Lack of Resources Faulted for Rarity of Randomized Surgical Trials B Y C HRISTINA F RANGOU

I

t’s one of the most common conclusions of studies in the surgical literature: The issue at hand should be evaluated by a randomized controlled trial.

But randomized controlled trials (RCTs) rarely happen in surgery.

Now, a new report argues that these trials don’t come to fruition because the

organization and support to help trialists plan and carry them out is lacking.

In a study published in the September issue of the American Journal of Surgery, researchers from Houston’s Methodist Hospital show that the processes in place to help surgical clinical trialists are haphazard and inefficient, failings that likely contribute to the low numbers of RCTs in surgery (2012;204:339-346.e5).

“Our findings show a remarkably

unsystematic process by which highly motivated individuals struggled to find the information and resources necessary to develop competence as trialists and to mount scientifically and ethically sound surgical trials,” concluded lead author Anna F. Jarman, BA, then a graduate student at The Methodist Hospital, and colleagues.

That lack of support and resources translates into a poor showing for

'What we found was a true sadness among those we talked to—sadness and frustration at the [inability] to get guidance, training and support when they had, as surgeons, a cutting-edge important idea.'

—Carol Ashton, MD, MPH

Get concise medical education videos at your fingertips.

surgeons in clinical trials, said the researchers. Only 7.6% of studies evaluating surgical procedures use a comparative clinical trial design, according to another study published online this summer in the Journal of the American College of Surgeons (2012 [Epub ahead of print]).

“Our results show that the methodologic quality of surgical trials, and their reporting, are in need of significant improvement,” said the authors.

The researchers acknowledged that unique hurdles to clinical trials exist in the field of surgery, but they argued that high-quality surgical research can be completed, even trials that include randomization and blinding, if a better support system existed.

The real failing is inadequate training of surgeons and researchers in clinical trial methods, which results in trials that end with “findings of questionable scientific value,” said the authors. They cautioned that such failings have significant ethical implications for patient care.

Senior authors Carol Ashton, MD, MPH, an internist, and Nelda Wray, MD, MPH, a pulmonologist, have worked together on quality assessment research for the past 30 years. Since 2008, they’ve focused their efforts on surgical trials, looking at the quality—or lack thereof—in surgical trials.

In their most recent project, the investigators interviewed 11 accomplished surgical trialists, each of whom played a role in one or more highly cited surgical trials. They also interviewed an additional four trialists who were attempting to launch their first trial. The group included 11 surgeons, two physicians, a research ethicist and a biostatistician.

(Of the 11 surgeons, nine currently hold a leadership role such as a deanship or chairmanship of an academic department.) All were asked about their use of clinical research resources and their perspectives on the practical utility and educational value of these resources.

Almost all interviewees said they see CLINICAL TRIALS page 10

9

10

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

of surgical culture, said Dr. Nelson.

“I certainly share some scientist on a landmark trial of Randomized trials do not integrate arthroscopy published in jcontinued from page 9 of the frustrations, but I knee easily into surgical practice, with 2002 that included a sham prolearned how to conduct trials as they went through issues like how to reimburse, how found clinical trials vastly cedure control group (N Engl J the process of setting up a trial and not from their to blind, and whether sham operad 2002;347:81-88). rewarding—challenging but Med educational training. They said they gained knowledge tions are ethical. And surgeons are Barbara Bass, MD, the John by actually performing trials, and to a lesser extent not always comfortable with the idea F. and Carolyn Bookout Distinvastly rewarding.” working as reviewers or as members of an institution- of equipoise, she said. guished Endowed Chair of Sur—Heidi Nelson, MD al review board. Said one: “Through that trial I just Dr. Nelson compared surgical gery at The Methodist Hospital, learned so much about clinical trials. … I became a trials with medical trials. “Medisaid the study hits on “an impormore seasoned investigator throughout the trial.” cal trials are often formulaic, whether it’s a new che- tant theme, long bemoaned, but rarely studied effecThe respondents made statements such as the expe- motherapy agent that goes through Phase I, II and II tively in the surgical community.” rience was “painful,” or they were “learning by making trials or a diabetes medicine that goes through a develDr. Bass, who was not a study author, said there are mistakes” and “had to do things on my own.” opment testing model.” not enough resources within academic departments “What we found was a true sadness among those Surgery lacks a similar well-built paradigm, she said. today to thoroughly train residents and fellows to be we talked to—sadness and frustration at the [inability] “In large part, that’s because surgical innovations and clinical trialists in surgery. to get guidance, training and support when they had, surgical technologies do not have the same straight“Our surgeons in academic departments are expected as surgeons, a cutting-edge important idea,” said Dr. forward path. The pipeline for surgical trials is not as to operate, teach, support institutional programs, and Ashton, the John F. and Carolyn Bookout Professor of well established or linear as for medical trials.” on top of that, be academically productive. Most chairs Surgical Quality and Outcomes Science at The MethThe study authors pointed out that a significant believe that training a cohort of surgeons to be accomodist Hospital, Houston, and a research professor of body of published literature and guidelines designed plished surgical trialists is an important goal. Unfortumedicine in surgery, Weill Cornell Medical Center, for surgical trialists exists and is growing annually. Part nately, gathering the resources to support that mission New York City. of the problem, they said, is that surgeons do not use it. is a tough challenge, particularly as return on investWhat makes the findings even more remarkTo date, more than 1,000 documents have been pub- ment, extramural research funding, for that type of able is that the surgeons surveyed represent a high- lished that provide guidance on clinical trials, includ- research in surgery remains very lean.” ly educated group in terms of clinical trial training, a ing 302 from the United States alone. Three-fourths In their report, the study authors laid out some suggroup expected to have a smooth experience organiz- of the guidance documents were released or updated gestions for trialists and would-be trialists, based on ing a clinical trial. Nearly half of those surveyed had in the past decade. their interviews with surgical trialists. They urged obtained some kind of formal education in clinical triAccording to the survey, surgical researchers gen- aspiring trialists to obtain formal training in the als beyond their doctoral degrees. Nine of the 11 sur- erally do not use the documents and guidance pub- methods and issues of clinical trials (both the progeons interviewed undertook a year or two of research lished by regulatory and professional organizations. grams from the ACS and VA were recommended); to as part of their training (although their research years Only three out of 15 interviewees mentioned pub- seek out mentors experienced in clinical trials; and to were spent mostly in laboratories and not in clinical lished guidelines for trialists. establish a strong network of collaborators like stattrials). And six of the physicians interviewed had vol“This seems unfortunate, given the wealth of infor- isticians and psychometricians. Finally, they recomuntarily sought out formal training in clinical research mation these documents contain on how to perform mended that surgical trialists seek out positions that leading to a master’s degree or graduate coursework. ethically sound and methodological rigorous clini- get them involved in various aspects of clinical trials.

Four surgeons had participated in seminars in clini- cal trials and how to report them,” said co-author Dr. As an example, joining a hospital’s IRB or participacal trial methods offered by organizations such as the Wray, also a senior member of The Methodist Hos- tion in a trial can be helpful, they said.

American College of Surgeons or the Veterans Affairs pital Research Institute. Dr. Wray served as the lead In an interview, the investigators also made a broad Cooperative Studies Program. recommendation to the surgical communiMost respondents said their didactic instructy on how to raise the bar on surgical trials. tion prior to starting the trial was inadequate.

They called on the surgical community to Instead, they reported that informal training establish a network of surgical trials that has from other people such as mentors, peers or colconsistent funding and includes surgeons laborators provided “some of the most imporand experts from other scientific fields. tant education on how to develop and execute a “We’d love to see an effort across the trial.” Even anonymous reviewers who provided country that ensures stable funding for a critiques on protocols, applications and mansurgical cooperative randomized trial netuscripts helped trialists to learn more about work so that new interventions can be tested the process. thoroughly before they widely disseminate,” Experienced surgical trialists said the report said Dr. Wray. paints an accurate picture of the current state of Many barriers to such a program exist, the surgical research. top being a lack of funding.

Heidi Nelson, MD, the Fred C. Andersen But the investigators said that they expect Professor of Surgery at Mayo Clinic, in Rochmore funds will become available for surester, Minn., is one of the country’s leading gical trials as a result of the Patient-Censurgical trialists. She co-chaired the Ameritered Outcomes Research Institute, created can College of Surgeons Oncology Group for by the 2010 Accountable Care Act. “I see seven years and led the landmark COST trial, this as a great opportunity now. Traditionally a multi-institutional Phase III prospective ranit’s been very difficult to get funding domized trial comparing laparoscopic and open for non-industry surgical trials,” said colon cancer surgery.

Dr. Wray.

Dr. Nelson agreed that the trial process Without more organization, the authors is fraught with frustration, but said that the said, surgeons and surgical trialists aren’t study underplays one element of the process: likely to attract funding dollars. The slapthe immense sense of reward that comes with dash structure for surgical trials also reduccompleting a trial. “I certainly share some of Chad Hoover, Ephemera #7, 48" x 48", oil on canvas. The surgeon es the chances of gaining external support, the frustrations, but I found clinical trials vastly and assistants navigate a complex deep abdominal procedure. For financial or otherwise, when up against rewarding—challenging but vastly rewarding.” more information about this painting, the series, or the artist, visit “highly trained competitors from fields Clinical trials have not historically been a part chad@chadhooverart.com. outside surgery,” the investigators said.

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SUR-BADV-MBNG-EN-201210

9LVLW www.RECOTHROM.com RU VFDQ WKH 45 FRGH ZLWK \RXU VPDU WSKRQH

RECOTHROM is a registered trademark of ZymoGenetics, Inc. Â&#x2039; =\PR*HQHWLFV ,QF $OO ULJKWV UHVHUYHG 57

7KURPELQ PDGH ZLWK D WZLVW RECOTHROM is human thrombin produced using recombinant DNA technology ² ,Q D JHQHWLFDOO\ PRGLĂ&#x20AC;HG &+2 &KLQHVH KDPVWHU RYDU\ FHOO OLQH Q 1RW GHULYHG IURP FDWWOH RU KXPDQ SODVPD Q &RQYHQLHQW DQG HDV\ WR XVH ² 5(&27+520 &RQYHQLHQFH .LWV DOORZ IRU TXLFN DQG HDV\ UHFRQVWLWXWLRQ Q )OH[LEOH SURGXFW OLQH ZLWK PXOWLSOH DSSOLFDWLRQ PHWKRGV ² 0D\ EH DSSOLHG GLUHFWO\ RU LQ FRQMXQFWLRQ ZLWK DEVRUEDEOH JHODWLQ VSRQJH 863

INDICATION RECOTHROM Thrombin, topical (Recombinant) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

IMPORTANT SAFETY INFORMATION Contraindications Â&#x2021; Topical use only â&#x20AC;&#x201C; DO NOT INJECT directly into the circulatory system Â&#x2021; Do not use for the treatment of massive or brisk arterial bleeding Â&#x2021; Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins Warnings and Precautions Â&#x2021; Potential risk of thrombosis if absorbed systemically Â&#x2021; In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction Adverse Reactions Â&#x2021; 7KH VHULRXV DGYHUVH HYHQW WKDW RFFXUUHG LQ Â&#x2022; Q RI SDWLHQWV H[SRVHG WR 5(&27+520 LQ FRPSOHWHG FOLQLFDO WULDOV ZDV DWULDO žEULOODWLRQ 7KH PRVW FRPPRQ DGYHUVH HYHQWV UHSRUWHG LQ WKHVH WULDOV 1 ZHUH LQFLVLRQ VLWH SDLQ

SURFHGXUDO SDLQ DQG QDXVHD $GYHUVH HYHQWV UHSRUWHG LQ WKHVH WULDOV were consistent with those commonly observed in surgical patients Please see Brief Summary of Full Prescribing Information on following page.

14

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Fewer Complications Cited for Robot-Assisted Lap Gastric Bypass B Y C HRISTINA F RANGOU SAN DIEGO—Adding robotic assistance to laparoscopic gastric bypass may lead to a slight reduction in complications compared with conventional laparoscopy, in the first 30 days after surgery, according to the largest reported series of robotics in bariatric surgery.

“This study suggests that, with robotics, we can take an already extremely safe

operation and make it even safer, and perhaps more cost-effective with the reduction we’re seeing in complications,” said lead author Erik Wilson, MD, metabolic and bariatric surgeon at the University of Texas Health Science Center at Houston and Memorial Hermann-Texas Medical Center.

He presented the study at the 2012 annual meeting of the American Society for Metabolic and Bariatric Surgery.

Dr. Wilson and his colleagues reviewed outcomes for 1,695 consecutive patients who underwent robotic-assisted laparoscopic gastric bypass surgery at the University of Texas Health Science Center at Houston (n=578), the Eastern Maine Medical Center, Bangor (n=708) and Florida Hospital Celebration Health, Celebration (n=409).

All patients underwent surgery performed with the da Vinci Surgical System

Immunogenicity The potential development of antibodies to RECOTHROM has been evaluated in multiple clinical trials. These pre-specified evaluations were performed in order to characterize the immunogenicity of RECOTHROM and the neutralizing potential of any detected antibodies. In completed clinical studies 5 of 552 (0.9%) patients exposed to RECOTHROM with both baseline and post-treatment antibody specimens available developed specific anti-RECOTHROM product antibodies. None of these antibodies were found to neutralize native human thrombin.

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION RECOTHROM® Thrombin, topical (Recombinant) Rx Only The following is a brief summary of the full prescribing information for RECOTHROM Thrombin, topical (Recombinant).

CONTRAINDICATIONS Do not inject directly into the circulatory system.

Do not use for the treatment of massive or brisk arterial bleeding.

Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM, or hamster proteins.

WARNINGS AND PRECAUTIONS Potential risk of thrombosis if absorbed systemically.

In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction.

ADVERSE REACTIONS The serious adverse event that occurred in ≥ 1% (n=6/583) of patients exposed to RECOTHROM in completed clinical trials was atrial fibrillation. The most common adverse events in patients exposed to RECOTHROM in clinical trials (N=583) were incision site pain (51%), procedural pain (30%), and nausea (28%).

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical trials have been performed with RECOTHROM applied with absorbable gelatin sponge (Phase 2, Phase 3, and Phase 3b studies) and applied with a spray applicator (Phase 2 study). Adverse events reported in clinical trials were consistent with those commonly observed in surgical patients.

Clinical Trials of RECOTHROM Used in Conjunction with Gelatin Sponge Among the 411 patients treated with study drug in the randomized, double-blind, Phase 3 study that compared RECOTHROM to bovine thrombin, both applied with gelatin sponge, in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, all but 2 patients (1 patient/treatment group) reported adverse events. Most events were moderate in severity and had a similar incidence in the RECOTHROM and bovine thrombin treatment groups. The most common adverse events were incision site pain (63% for both treatment groups), procedural pain (RECOTHROM 29%; bovine thrombin 34%), and nausea (RECOTHROM 28%; bovine thrombin 35%). Serious adverse events were reported by 18% of patients treated with RECOTHROM and 22% with bovine thrombin.

In the randomized, double-blind, Phase 3 study that compared RECOTHROM to bovine thrombin, both applied with gelatin sponge, in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, the development of specific anti-product antibodies was evaluated in both treatment groups. Blood samples were collected at baseline and at day 29 for 97% of the patients in both treatment groups.

For patients randomized to RECOTHROM, the samples were analyzed by ELISA for antibodies to RECOTHROM, Chinese hamster ovary (CHO) host cell protein, and pro-thrombin activator (used in the conversion of single chain precursor to active RECOTHROM). For patients randomized to bovine thrombin, the samples were analyzed by ELISA for antibodies to bovine thrombin product.

At baseline 1.5% of patients (n=3/198) in the RECOTHROM group had positive anti-product antibody titers compared with 5% of patients in the bovine thrombin group (n=10/200). Of the patients who had detectable anti-product antibodies at baseline, 0 of 3 in the RECOTHROM group and 8 of 10 in the bovine thrombin group exhibited ≥ 1.0 titer unit (≥ 10-fold) increases in antibody levels after study treatment.

Treatment with RECOTHROM applied with absorbable gelatin sponge resulted in a statistically significantly lower incidence of specific anti-product antibody development. Three of 198 (1.5%; 95% CI, 0 to 4%) of the patients in the RECOTHROM arm developed specific anti-thrombin product antibodies (1 patient also developed anti-CHO host cell protein antibodies). No patients developed antibodies to pro-thrombin activator. Forty-three of 200 patients (22%; 95% CI, 16 to 28%) in the bovine thrombin arm developed specific antibodies to bovine thrombin product. None of the antibodies in the RECOTHROM group neutralized native human thrombin. Antibodies against bovine thrombin product were not tested for neutralization of native human thrombin. Because the study was not powered to detect a difference in clinical outcomes attributable to antibody formation, no conclusions can be drawn regarding the clinical significance of the difference in antibody formation based on the results of this study.

In the open-label, single group, Phase 3b study in patients with a high likelihood of prior bovine thrombin exposure undergoing spinal, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, 15.6% of patients (n=32/205) had anti-bovine thrombin product antibodies at baseline prior to treatment with RECOTHROM. Following treatment, none of the 200 evaluable patients (patients for whom specimens were available for antibody testing at baseline and post-RECOTHROM treatment) developed antibodies to RECOTHROM. In the randomized, double-blind, controlled Phase 2 studies of RECOTHROM compared to placebo (RECOTHROM excipients reconstituted with 0.9% sodium chloride, USP) applied in conjunction with absorbable gelatin sponge, which were performed across a range of surgical settings (spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access), the incidence of antibody development to RECOTHROM was 1.2% in the RECOTHROM group (n=1/83) compared to 2.4% (n=1/41) in the placebo group. In the open-label, single group Phase 2 study of RECOTHROM applied with the spray applicator to excised burn wounds, 1 patient developed antibodies following treatment (1.6%, n=1/62).

Adverse events of interest were pre-specified, based on the thrombin mechanism of action, use of absorbable gelatin sponge, USP, historical reporting in association with cross-reacting antibodies to bovine thrombin product, and results from Phase 2 clinical trials of RECOTHROM applied with absorbable gelatin sponge. The incidences of these pre-specified adverse events were similar between treatment groups (see Table 1).

The detection of antibody formation is highly dependent upon the sensitivity and specificity of the assay. The absolute immunogenicity rates reported here are difficult to compare with results from studies of other products due to differences in assay methodology, patient populations, and other underlying factors.

Table 1. Events of Interest in the RECOTHROM Phase 3 Study

To report p SUSPECTED ADVERSE REACTIONS,, contact ZymoGenetics, y , Inc. at 1-888-784-7662,, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. g

AE Category* Patients with any event category Bleeding Cardiac Hypersensitivity Nausea + vomiting Other infection Post-operative wound infection Thromboembolic

RECOTHROM (N=205) n (%) 124 (60%) 27 (13%) 41 (20%) 30 (15%) 68 (33%) 26 (13%) 19 (9%) 12 (6%)

†

Thrombin-JMI (N=206) n (%) 136 (66%) 24 (12%) 38 (18%) 37 (18%) 83 (40%) 31 (15%) 22 (11%) 10 (5%)

*

Adverse events were included in event categories based on a blinded review of the investigator verbatim and coded terms. † THROMBIN-JMI® Thrombin, Topical (Bovine).

In an open-label, single-group Phase 3b study, 209 patients with documented or highly likely prior exposure to bovine thrombin within the previous 3 years were treated with RECOTHROM when undergoing surgeries (spinal or peripheral arterial bypass or arteriovenous graft formation for hemodialysis access). The most common adverse events were incision site pain (45%), procedural pain (39%), and nausea (27%). Similar to the Phase 3 study, serious adverse events were reported by 22% of patients treated with RECOTHROM. Clinical Trials of RECOTHROM Applied with Spray Applicator In an open-label, single-group, Phase 2 study in burn patients, 72 patients were treated with RECOTHROM applied with a spray applicator at the burn wound excision site prior to autologous skin grafting. This study included both adults (≥ 17 years of age, n=68) and pediatric patients ≤ 16 years of age (n=4). The most common adverse events in the adult and pediatric age groups included procedural pain (35%), pruritis (25%), and constipation (19%).

DRUG INTERACTIONS Drug interactions have not been formally studied.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with RECOTHROM. It is also not known whether RECOTHROM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RECOTHROM should be given to a pregnant woman only if clearly needed.

Pediatric Use Of the 72 patients undergoing burn wound excision and grafting treated with RECOTHROM applied with the spray applicator in the open-label, single group, Phase 2 study, 4 were pediatric patients.

All were age 12 to 16 years. The safety and effectiveness of RECOTHROM in all pediatric age groups have not been fully established.

Geriatric Use Of the total number of patients in Phase 2 and Phase 3 clinical studies of RECOTHROM with absorbable gelatin sponge, 38% were 65 years old and over, while 16% were 75 years old and over.

No substantive differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

For Full Prescribing Information, access www.RECOTHROM.com Manufactured for ZymoGenetics, Inc. RT022-06, January 2011

(Intuitive Surgical) between 2003 and 2011 and had an average preoperative body mass index of 48 kg/m2.

No patient died within the first 30 days after surgery; the study showed a mortality rate slightly below the 0.2% often cited for laparoscopic gastric bypass, based on a study of hospitals in Michigan (JAMA ( 2010;304:435-442).

Major morbidity was reported in 1.5% of patients, and included three anastomotic leaks (0.12%), three abscess leaks (0.18%) and 14 bleeds requiring transfusions. Four patients had early strictures diagnosed (0.2%).

In April, the American College of Surgeons Bariatric Surgery Center Network Accreditation Program reported a 30-day mortality rate of 0.14% and a morbidity rate of 5.02% among 14,491 patients who underwent laparoscopic gastric bypass between 2007 and 2009 ((Ann Surgg 2011;254:410-420).

But it is misleading to compare the robotic series with previously published studies. The patients are not matched, the surgeon experience is not matched, and the robotic series represents only a very small number of patients compared with the patients in the national bariatric database.

Even so, surgeons said the new report shows conclusively that the robot is a safe and effective tool for minimally invasive surgery in bariatric patients.

“This report shows that, in the hands of experienced robotic surgeons, the robotic is certainly as safe, and perhaps safer, than the laparoscopic approach,” said Ranjan Sudan, MD, a bariatric and robotic surgeon and vice-chair of education, Duke University Health System, Durham, N.C. Dr. Sudan performed the first robotic bariatric surgery in 2000.

However, neither this study, nor any of the previously published studies of robotic bariatric surgery, shows an advantage of using the robot, he said.

Robotic surgery is more expensive and more time-consuming, particularly early in the surgeon’s learning curve compared with conventional laparoscopy. The robot costs more than $1 million to purchase, with an additional $1,000 to $1,400 for instruments per case.

Studies will have to show a conclusive advantage for using the robot if it is going to gain widespread acceptance in bariatric surgery during an era of increased consciousness about health

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

‘In the hands of experienced robotic surgeons, the robot is certainly as safe, and perhaps safer, than the laparoscopic approach.’

—Ranjan Sudan, MD care costs, Dr. Sudan said.

“We need research that compares the outcomes, the patient benefits, the ergonomics (for the surgeon) and the cost. Until we have that, we are not going to be able to convince anyone that the robot is much better.”

In this series, surgeons at the three centers performed a roboticassisted procedure. One surgeon sat away from the operating table at a console, where he or she manipulated two robotic arms to perform surgery. At the Maine hospital, surgeon Michelle Toder used a three-port technique and performed the operation in conjunction with a very skilled physician assistant. In Texas and Florida, surgeons performed an operation that is more of a “one-person surgery.” All aspects of the procedure other than stapling were performed through the robot. (The robot does not have stapling capabilities so this is performed through the port).

Eighty-one patients (4.8%) required readmission to hospital after surgery and 46 (2.7%) underwent reoperation.

Reasons for reoperation included bowel obstruction in 17 patients, infection in five patients, bleeding in 18 patients and negative explorations in six patients.

The mean operating time varied among the three centers. The average time was 156 minutes in Texas, where all cases were teaching cases. In Orlando, operative times dropped to 128 minutes

and in Maine, where all cases were done at a private hospital, operative times averaged 104 minutes.

According to Dr. Wilson, operative times are decreasing and now reach about 90 minutes in Texas, nearly half of what it was in 2003, and in Maine, operative times are less than 60 minutes. “Operative times are now comparable to what you can do laparoscopically,” he said.

Several authors have tried to compare robotic and laparoscopic surgery using published prospective studies. The largest, a systematic review published last

fall, found patients who were operated on with a robot had a significantly reduced incidence of anastomotic stricture in the robotic group (pooled odds ratio, 0.43; 95% confidence interval, 0.19-0.98; P=0.04). Investigators found no significant difference between robotic and laparoscopic groups for anastomotic leak, postoperative complications, operative time and hospital length of stay (Int J Med Robott 2011;7:393-400).

The findings were based on an analysis of seven studies comparing robotic and laparoscopic Roux-en-Y gastric bypass in 1,686 patients.

“

Some experts said that it is unlikely a randomized trial will ever be performed that could measure between robotic and laparoscopic surgery. Any differences between the two procedures are small and to quantify the differences would require a trial involving thousands of patients.

Dr. Wilson disclosed that he is a consultant for Apollo Endosurgery, EndoGastric Solutions, Ethicon EndoSurgery and Intuitive Surgical; a proctor for Intuitive Surgical; and the recipient of an educational grant from Gore. Dr. Sudan reported no relevant disclosures.

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16

In the News BARRETT’S ESOPHAGUS jcontinued from page 1

specialists about when the most appropriate time is to administer RFA in the progression of BE. “The gastroenterologists really don’t feel like BE is a big problem—that it’s kind of an anatomic peculiarity and not something to be frightened about,” said Lee Swanstrom, MD, FACS, clinical professor of surgery, Oregon Health & Science University, Portland.

‘With the majority of LGD, we find that it disappears after the first endoscopy is done, so we pretty much wait on those patients because the majority of the LGD disappears in the follow-up endoscopy.

—Prateek Sharma, MD “I think surgeons tend to be a little more aggressive about it, considering it premalignant along the same lines as colon polyps,” he said. “For my patients with low-grade dysplasia, we do tend to recommend that they have an ablation.

We [first] treat them intensively, medically, and repeat their biopsies, but if it comes back a second time as low-grade dysplasia, then we will recommend those patients undergo ablation.”

This philosophical difference in approach becomes one of great significance as gastroenterologists, who were previously focused more on diagnostics, have entered the realm of treating BE through RFA, which as an endoscopic procedure falls neatly into their sphere of practice.

Prateek Sharma, MD, associate professor of medicine, Division of Gastroenterology and Hepatology, University of Kansas School of Medicine, Kansas City, doesn’t tend to use RFA on all patients

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

with low-grade dysplasia (LGD).

“With the majority of LGD, we find that it disappears after the first endoscopy is done, so we pretty much wait on those patients because the majority of the LGD disappears in the follow-up endoscopy.

It is a difficult disease to define because even expert pathologists cannot agree on the diagnosis,” said Dr. Sharma.

During an RFA procedure to treat BE, a sizing balloon is inserted into the esophagus, followed by a catheter that inflates to meet the inner esophageal lining. A controlled burst of ablative energy is then administered through the catheter, burning away the abnormal cells of BE and leaving room for new cells to grow in their place.

Before ablation became available as an option for treating LGD, the standard of care for patients in this phase was surveillance. Guidelines from the American Gastroenterological Association (AGA) recommend surveillance intervals for LGD patients every six to 12 months (intervals for nondysplastic BE are suggested every three to five years). But the introduction of RFA into the mix has raised the question of whether it is more cost-effective in the long run to replace surveillance with ablation, even though most people with LGD will never progress to cancer.

“Some people with LGD will get cancer, but who are they?” asked Yvonne Romero, MD, esophagologist and assistant professor of medicine, Mayo Clinic College of Medicine, Rochester, Minn.

“You would need to ablate about 400 people with nondysplastic BE to help one from developing cancer,” she said.

Individuals at most risk for developing BE are white men aged 50 years and older, who are overweight and have a history of gastroesophageal reflux disease. Although the progression from BE to adenocarcinoma is uncommon, when it does develop, it has a very low survival rate. Only 15% to 20% of patients will survive at least five years after diagnosis. According to the American Cancer Society, more than 17,000 new cases are expected to be diagnosed in 2012 and more than 15,000 patients will die from adenocarcinoma, which is the most rapidly increasing

Procedural steps for endoscopic mucosal resection.

Commentary David Earle, MD, Series Editor Barrett’s esophagus (BE) is a disease process that is complex and crosses specialties for diagnosis and management. Each specialty has inherent biases toward patient care, leading to wide practice variability. Because the management of BE is usually high-tech, health care economics will have an additional effect on research and development. As this article brings together thoughts from different specialties, with specific focus on BE, we will hopefully move toward a multidisciplinary approach to clinical care and device development. This type of approach will improve sharing of knowledge and skill, reduce poor practice techniques, and maintain innovation and research for a disease that can cause both physical and emotional distress for all those involved.

Dr. Earle is director of Minimally Invasive Surgery, Baystate Medical Center, Springfield, Mass., and assistant professor of surgery, Tufts University School of Medicine, Boston.

cancer in the Western world.

Dr. Swanstrom believes that more attention needs to be given to the management of BE. “I think it’s not totally settled that waiting until a patient has HGD [highgrade dysplasia] and then trying to ablate them is the best therapy,” he said. “There should be a public policy debate on whether all patients with chronic reflux disease should have an endoscopy and if they have Barrett’s esophagus, be ablated.”

Specialists differ not only in their response to the low cancer risk inherent in LGD, but in the diagnosis of BE itself.

If a particular phase of the disease is misdiagnosed, then using RFA could end up either undertreating HGD and superficial cancer or overtreating LGD, positioning RFA against a moving target.

For example, histologic characteristics of LGD are similar to that of cell inflammation and therefore can lead to difficulty in pathologic interpretation. “One thing that is hard to determine is—do cells look funny because of inflammation or funny because of an actual genetic change?” Dr. Romero pointed out.

“The accuracy rate of determining

‘The day [the guidelines] are published, there could be a brand new article that comes out in the literature that completely revolutionizes the way you think about things and it will take years before the guidelines catch up.’

—Steven DeMeester, MD what is really LGD is pretty low and that’s a problem,” Dr. Swanstrom said.

“That leads some people to recommend treating it aggressively with ablation— better safe than sorry—and other people saying, ‘well, it’s a 50-50 chance of it really being LGD, so let’s just wait and see until we know for sure before you add to

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

‘There should be a public policy debate on whether all patients with chronic reflux disease should have an endoscopy and if they have Barrett’s esophagus, be ablated.”

—Lee Swanstrom, MD the cost of the patient’s treatment.’ ” Although less ephemeral a diagnosis, determining the phase of HGD also is open to dispute, primarily because the interpretation of pathologic results of biopsies can differ widely. According to AGA guidelines, the “risk for progression from LGD to HGD or adenocarcinoma remains controversial [because of the] difficulty in distinguishing dysplasic from nondysplastic BE and determining with reproducible accuracy the degree of dysplasia.”

The standard protocol for performing biopsies in patients with BE is four-quadrant specimens taken every 2 cm and is recommended by the AGA, the American College of Gastroenterology (ACG) and the American Society for Gastrointestinal Endoscopy (ASGE). For patients with known or suspected dysplasia, the societies recommend the Seattle protocol, which requires four-quadrant specimens taken every 1 cm.

However, the AGA notes in its medical position statement on the management of BE that “many practicing gastroenterologists do not adhere to those guidelines.”

Dr. Romero said that increasing the sampling surface area from 2 cm to 1 cm is still an insufficient sample. “There is error in the system because we only sample a small amount of mucosa. Even if you double from 1% to 2%, it’s not like you

capture 50% of the mucosa,” she said.

A recent study (Clin Gastroenterol Hepatoll 2009;7:653-658) supports the view that in patients with HGD, surveillance using the Seattle protocol may not be adequate for cancer detection and recommends that patients be evaluated by endoscopic mucosal resection (EMR). A distinct advantage of EMR is that the abnormal tissue removed can be sent to the lab for analysis, whereas with RFA, biopsies cannot be done at the same time as ablation due to the risk for perforation and strictures, so in effect, ablation burns the evidence.

“Ablation is a welcome technology in the right person with the right amount of disease and who is willing to live with risk,” said Dr. Romero. “I’m one of the people who isn’t terribly enthusiastic about ablating. Endoscopic mucosal resection is the key. No one argues against it. EMR is a slam-dunk advance in our field.”

‘Endoscopic mucosal resection is the key. No one argues against it.

EMR is a slamdunk advance in our field.’

—Yvonne Romero, MD

which leads to the question of who is best positioned to advise on the range of treatment options for BE: One particular study shows that specialists tend to more frequently recommend treatments that fall within their own field of practice (Dis Esophaguss 2008;21:241-250).

“Different specialties will likely converge more,” said Steven DeMeester, MD, associate professor, University of Southern California, Los Angeles. “As we’re moving to a point where we’re doing more and more things ‘Unfortunately, we have through the endoscope—both specialized in such a way that gastroenterologists and surgeons—you can see the natuwe specialize to procedure rather ral tendency would be for the than specializing to disease.’ blending of those two fields into people who are consid—Gary Hochheiser, MD ered experts in endoscopic surgery.” A thoracic surgeon, Dr. Prior to the advent of ablation, the DeMeester performs “the A to Z on the standard of care for HGD was an esopha- esophagus,” including endoscopic resecgectomy, a major surgical procedure and a tion, ablation and esophagectomies. “But potentially traumatic one for BE patients I’m rare, very rare,” he said. who tend to be older and have comorbid Gary M. Hochheiser, MD, chief, thoconditions that make surgery of this mag- racic surgery, Baystate Medical Center nitude very difficult. and assistant professor of surgery, Tufts RFA (combined with EMR) has given University School of Medicine, Boston, patients an alternative to such an invasive said, “Unfortunately, we have specialized procedure, yet it poses its own dilemma: in such a way that we specialize to proIt does not guarantee the complete elim- cedure rather than specializing to disease. ination of precancerous cells in the long And so a gastroenterologist is specialterm, nor can it address the risk for sub- ized to do endoscopy, a surgeon is spemucosal abnormalities, therefore commit- cialized to operate, but is there someone ting the patient to a lifetime of follow-up who is specialized to treat esophageal disendoscopies. In contrast, esophagecto- ease from top to bottom? I don’t think my, for obvious reasons, can provide this our training programs are set up that way. peace of mind.

If you can develop a program that has a Although both gastroenterologists and multidisciplinary team and you all treat surgeons perform RFA, an esophagecto- the patient together, then that is just as my is solely in the domain of surgeons, good, if not better, because having more

minds involved is better than having one person try to do all of this themselves.”

Various surgeon and gastroenterologist societies have created guidelines in an effort to streamline procedures like RFA, but differences in their recommendations exist. Guidelines are of no great value, Dr. DeMeester said, as they cannot keep up with the pace of medical research and technology.

“Medicine is constantly moving forward. The day [the guidelines] are published, there could be a brand new article that comes out in the literature that completely revolutionizes the way you think about things and it will take years before the guidelines catch up.”

One of the co-authors of a recent international paper on the management of HGD (Gastroenterology 2012;143:336346), Dr. Romero said, “We accept that guidelines will change with medical advancements, but the question is can we hammer down a process where we are all involved in the conversation?”

According to Dr. Romero, research already is under way to find a more definitive way to pinpoint the various stages of BE. Biomarkers such as stool, urine and blood samples are being studied as possible alternatives to biopsies. “My question is how can we get endoscopists and pathologists out of the equation?”

New RFA medical devices are being launched by companies like Barrx Medical (recently acquired by Covidien) that broaden the scope of patients who qualify for ablation therapy, including those with strictures or other esophageal conditions.

“All these [new devices] open up new doors to treat patients who, a year ago, you would struggle to treat because of the limitations in the technology and the catheter design,” Dr. DeMeester said.

However, although medium-term results of RFA are encouraging, the long-term effects remain to be seen.

“I think [RFA] is a fantastic technology,” said Dr. Swanstrom. “It works amazingly well to get rid of BE. But there are a lot of questions we don’t know about it.

Like, do you need to do something else to make sure it doesn’t just come back in seven or 10 years? In which case, it’s a waste of money.”

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Surgeons‘ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Dear Readers,

Welcome to the November issue of The Surgeons’ Lounge. This issue features Martin Newman, MD, from the Department of Plastic Surgery, who is head of Clinical Research at Cleveland Clinic Florida, Weston, and Michel C. Samson, MD, from the Department of Plastic Surgery, Cleveland Clinic Florida, Weston. Drs. Newman and Samson reply to a question related to recommended analgesia care following reconstructive thoracic surgery after tumor extirpation.

Check out the answer to the Surgeon’s Challenge—how did you do?

We conclude this issue with The EuroAsian Corner, in which David Hazzan, MD, discusses totally laparoscopic right hemicolectomy with transvaginal specimen extraction.

I hope all our U.S. readers went out and voted earlier this month!

As always, we greatly value our readers’ opinions and encourage all feedback.

Sincerely, Dr. Szomstein n is associate director, Samuel Szomstein, MD, FACS Bariatric Institute, Section of Minimally Editor, The Surgeons’ Lounge Invasive Surgery, Department of Szomsts@ccf.org General and Vascular Surgery,

See Answer to The Surgeons’ Challenge on page 22

Cleveland Clinic Florida, Weston.

Question for Drs. Newman and Samson From Pedro Vieira, MD New Jersey Medical School, University of Medicine and Dentistry of New Jersey, University Hospital General Surgery Program

We are planning to perform a thoracic surgery with reconstruction following tumor extirpation. The patient is an otherwise healthy 75-year-old woman with a recurrent, locally invasive subscapular spindle cell tumor. It is likely that the resection will include several segments of posterior ribs at or around the T4 level. My plan for reconstruction includes placement of a prosthetic mesh with muscle flap coverage. Considering the level of postoperative pain that can be expected in such cases, as well as our plans for reconstruction, can you provide a recommendation for postoperative analgesia?

Dr. Newman’s

Reply

This is an excellent question.

Thoracic wounds and subsequent reconstructions such as the one you anticipate are often associated with substantial postoperative pain. Often the intensity of pain following thoracic surgery and reconstruction is greater than that seen with wounds of the abdomen, cranium or extremities.

Broadly speaking, I look at the options

for postoperative pain control as surgeons also have noted the benefits generally falling into one of two classes: of these devices, and the literature has centrally acting agents such as narcotics, become replete with manuscripts that and agents that act locally. Narcotics and cite their advantages. However, despite other centrally acting analgesics are a the many benefits associated with use well-established option for postoperative of indwelling catheters that deliver local pain control. The pharmacokinetics of anesthetics, there are drawbacks. One these medications are well understood. drawback is the theoretical increase in Similarly, the negative side-effect profiles the risk for infection associated with of these medications are familiar to, and indwelling catheters. Although the in many cases dreaded by, surgeons, increase is theoretical, I try to limit the nurses and experienced number of foreign bodies Agents that act in surgical reconstruction patients. Although not all centrally acting agents locally have taken sites. Prosthetics, such as have an identical profile, in the case you present, naturally occurring a greater role in my are sometimes necessary as and synthetic opioids are closed suction drains. practice in generally tend to make However, the addition recent years. patients sluggish. Since of an indwelling catheter pulmonary, toilet, and to this mix concerns me ambulation factors play such vital roles in and may dissuade me from placing the recovery process of thoracic patients, yet another foreign body in an already I would recommend using these agents crowded surgical field. In addition, cost sparingly during the postoperative is a drawback. These “pumps” can be phase. I would not eliminate them expensive. In an economic climate such completely, but instead use them as an as the current one, the cost of these adjunct in my armamentarium. The devices is evaluated not only as an outlevel of the surgery also concerns me. of-pocket expense, but also as the “time Although I have significant respect for to fill” the device. epidural blocks and catheters in their Luckily, there are other options. ability to reduce postoperative pain and Recently, a pharmaceutical company narcotic consumption, the high thoracic specializing in slow-release drug location of the tumor precludes the use delivery liposomes has made available of epidural anesthesia. Agents that act a slow-release bupivacaine formulation. locally have taken a greater role in my According to the manufacturer, the practice in recent years. The advent of medication can be injected into the devices with implantable indwelling surgical incision. Slow release of the catheters designed to direct the slow but bupivacaine is said to last 72 hours. If constant administration of long-acting this product delivers as promised, it will local anesthetics has made a difference be a significant and desirable advance in my practice. For the past eight to 10 for patients: Not only will we be able to years, these tools have played an ever- reap the maximum anesthetic benefits increasing role in my management of associated with local agents, but also will postoperative analgesia. Personally, I have be able to avoid the theoretical risks and noted a decreased need for narcotics and costs associated with indwelling catheter a faster recovery in my patients. Other infusion pumps.

Dr. Samson’s

Reply

I agree with Dr. Newman, and I can share an anecdotal experience. Recently, I had a case similar to the one you are describing, in which I had the opportunity to use the slow-release liposomal formulation of bupivacaine. Similar to the case that Dr. Vieira is describing, in my recent case, ablation incorporated several posterior rib segments involved with the neoplastic process. The defect was reconstructed with a synthetic mesh that I covered with a latissimus dorsi muscle flap. I injected the liposomal bupivacaine directly into the muscle and ribs surrounding the defect and the reconstruction. As is my practice in these cases, I left closed suction drains, which I brought out remotely from the incision but I did not use indwelling catheters designed to deliver local anesthetic.

In retrospect, I found the postoperative pain control remarkable. On rounds during Postoperative day (POD) 1, I found the patient sitting up in a chair eating breakfast and smiling. She reported her pain as being minimal and controlled with acetaminophen.

She ambulated well on that day and throughout the subsequent days. On POD 4, it was obvious to me that the beneficial effects of the liposomal bupivacaine were decreasing. She began, for the first time, to complain about postoperative pain and began asking for PRN hydrocodone. This seemed to manage her pain well. She continued to participate in respiratory therapy and to ambulate throughout her hospitalization. see SURGEONS’ LOUNGE PAGE 20

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Surgeonsâ&#x20AC;&#x2122; Lounge jcontinued from page 18 She eventually was discharged and is doing well. This case illustrates one positive experience I had with the liposomal formulation of bupivacaine.

However, I have used this medication several times since, for patients undergoing reconstructive procedures as well as patients undergoing cosmetic procedures. I have continued to have good experiences with it. I believe slowrelease liposomal bupivacaine represents the next phase in providing patients with the postoperative analgesia they desire and deserve.

Disclosures: Drs. Newman and Samson serve as consultants to Pacira Pharmaceuticals, Inc. Dr. Newman is a consultant for LifeCell Corporation.

EuroAsian Corner

By David Hazzan, MD Laparoscopic surgery is a wellestablished alternative to open surgery for the treatment of patients with benign and malignant right-sided colon pathologies. Early concerns about the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

oncologic outcomes of laparoscopy have been addressed by trials reporting equivalent oncologic outcomes between the two approaches. Despite the very good results obtained by advances in laparoscopic surgery, an abdominal wall incision has been necessary to retrieve the specimen and in some cases to perform the anastomosis, either by a midline, Pfannenstiel or muscle-splitting incision. The larger the abdominal incision, the greater the risk for wound-related morbidity, such as incisional hernias and wound infection.1 To eliminate the need for a counter-incision for extraction and anastomosis construction, transvaginal extraction has been described for left and right laparoscopies, as well as total colectomies (Figures 1-5). The vagina has been used to access the abdominal cavity since 1910, and since then it has been widely used for the extraction of surgical specimens such as the gallbladder, kidney and spleen.2 In 1996, Redwine et al3 reported the first series of transvaginal colon removals in five women with endometriosis of the sigmoid colon.4 Since then, a few case series and case reports have been published describing different techniques for right-sided colon

Figures 1 and 2. Side-to-side isoperistaltic anastomosis.

Figure 3. Posterior colpotomy area ready to be created against the transvaginal endobag.

Figure 4. Transvaginal specimen extraction.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Figure 5. Endobag inserted to the abdomen through the posterior colpotomy.

pathologies. In order to perform the procedure, advanced laparoscopic surgical skills are needed; transection of the specimen and anastomosis should be done intracorporeally.

In 2010, Park et al5 reported a case series of 14 patients with right-sided colon adenocarcinoma. His group used four 5 mm trocars and one 11 mm trocar for the camera. A 12 mm trocar was placed through the posterior vagina and a 60 mm endoscopic stapler device was introduced through it in order to create a functional end-to-end anastomosis in an antiperistaltic fashion. After placement of the specimen into a retrieval bag, the vaginal colpotomy was enlarged to 3 to 4 cm long and the specimen was removed.

Finally, the posterior colpotomy was closed transvaginally with absorbable sutures. In the same year, McKenzie6 reported his experience in four patients with right colon adenocarcinoma. We recently summarized our institutional experience of 11 patients with malignancy of the right colon. All patients underwent a formal oncologic laparoscopic right hemicolectomy with isoperistaltic sideto-side end functional intracorporeal anastomosis, followed by transvaginal extraction of the resected specimen.

None of the cases required an open conversion, but in one patient the planned transvaginal retrieval of the specimen was aborted because of severe carbon dioxide retention and an inability to tolerate the steep Trendelenburg position necessary to perform the posterior colpotomy. The median operating time was 128 minutes (range, 102-154 minutes). The median number of harvested lymph nodes was 16.8 (range, 12-26). There was no perioperative mortality or major morbidity, except one case of postoperative rectal bleeding that was conservatively managed. No patient experienced complications directly associated with the transvaginal approach, and the median hospital stay was five days (range, four to eight days). Despite a small number of case series and the lack of randomized studies, I think that totally laparoscopic, right hemicolectomy with intracorporeal anastomosis and

transvaginal retrieval of the specimen is a feasible and safe alternative for selected patients with right-sided colon cancer.

A careful review of gynecologic history and preoperative consultation is required when selecting appropriate female patients. In general, transvaginal access is not recommended for patients who have vaginal narrowing, are virgins, have a history of endometriosis or are planning a pregnancy. The described procedure may be applicable to small tumors and early colon cancer, and serve as a bridge between conventional laparoscopic surgery and incision-free surgery. More

studies with long-term follow-up are necessary to establish the role of this technique in the treatment of right-colon benign and malignant diseases.

4.

Torres RA, Orban RD, Tocaimaza L, et al. Transvaginal specimen extraction after laparoscopic colectomy. World J Surg.

2012;36:1699-1702.

5.

Park JS, Choi GS, Lim KH, et al. Clinical outcome of laparoscopic right hemicolectomy with trasvaginal resection, anastomosis, and retrieval of specimen. Dis Colon Rectum.

2010;53:1473-1479.

6.

McKenzie S, Baek JH, Wakabayashi M, et al. Totally laparoscopic right colectomy with transvaginal specimen extraction: the authors’ initial institutional experience. Surg Endosc.

2010;24:2048-2052.

References 1.

2.

3.

Hackert T, Uhl W, Buchler MW. Specimen retrieval in laparoscopic colon surgery. Dig Surg. 2002;19:502-506.

Harrel AG. Minimally invasive abdominal surgery: lux et veritas past, present and future.

Am J Surg. 2005;190:239-243.

Redwine D, Koning M, Sharpe DR. Laparoscopically assisted transvaginal segmental resection of rectosigmoid colon for endometriosis. Fertil Steril. 1996;65:193-197.

see SURGEONS’ LOUNGE PAGE 22

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

RADIOFREQUENCY jcontinued from page 1

“The pathologist can’t look at everything. For a 2-cm piece of tissue they would have to get 3,000 sections, which is impossible,” Dr. Klimberg said. ”The fact is it’s more important what I left behind than what I took out.

The only way to sterilize that cavity is to use some steam or heat, and that’s basically what we’re doing.”

Radiation after lumpectomy is equal to mastectomy in terms of local recurrence and survival, but the cosmetic effects of radiation can be less than desirable. “Radiation is the gift that keeps on giving—it keeps shrinking the breast over time,” Dr. Klimberg said.

With RFA, “the heat takes care of what the radiation does, at the same time, and doesn’t have long-lasting effects. You end up with a very nice cosmetic result,” she said.

Another limitation to radiation therapy is that it is not practical or even feasible for all patients. “We live in a rural state, Arkansas, and we have patients who choose mastectomy because they can’t afford to leave their livelihood, to leave the farm animals for six weeks or even a week to come in for radiation,” Dr. Klimberg said.

Although some centers do offer intraoperative radiation, its cost can be prohibitive.

“The machines cost more than a million dollars to set up,” Dr. Klimberg said. “[RFA] technology costs less than $30,000 to set up and is very low-maintenance, so it would be conducive to have in small and rural hospitals.

It’s the only thing being introduced for treating patients that is lesss expensive, so it would also be practical in Third-World countries where, for the most part, women get mastectomies.”

People have tried to ablate the tumor within the breast,

Radiofrequency ablation being deployed in an open breast cavity intraoperatively.

Photo courtesy of V. Suzanne Klimberg, MD

but tumors have a different density and resistance from normal tissues, “so unless it’s a very tiny tumor, it’s very difficult to use heat, laser or current to ablate a tumor,” Dr. Klimberg said. “To achieve the best results, you have to take the tumor out and ablate the margins, and that’s the difference between what we’re doing and what other people have tried.”

To test their hypothesis that eRFA could extend the margin by 1 cm, decrease the re-excision rate and provide benefits similar to radiation at the time of surgery, the researchers conducted a Phase II trial of that twostep process in 73 patients with invasive breast cancer and an average tumor size of 1.1±0.61 cm (range, 0.22.5 cm) who did not undergo adjuvant or neoadjuvant chemotherapy.

“After standard surgical lumpectomy, a purse-string suture was placed around the cavity, and our ablation probe was placed into the cavity and maintained at 100°C for 15 minutes. Doppler sonography was used to follow margin ablation. Our preclinical and in vivo study showed this consistently affected a 1-cm ablation zone,”

Dr. Wilson said.

Of the 73 patients, 19 had inadequate margins less than or equal to 2 mm. Of these patients, 16 (84%) with close or focally positive margins did not require re-excision.

“Only three out of 73 patients returned to the operating room for re-excision,” Dr. Wilson said.

In the median follow-up of 55 months, there was only one local recurrence and there were three elsewhere recurrences, all in the ipsilateral breast. Of the 40 patients who were scored using Radiation Therapy Oncology Group (or RTOG) cosmesis scoring, 90% reported good to excellent cosmesis.

“In conclusion, eRFA could reduce the need for re-excision to obtain adequate margins. Long-term follow-up suggests that in patients with favorable breast cancer, or those who can’t or won’t have radiation, eRFA could reduce local recurrence without need of radiation therapy,” Dr. Wilson said.

“I think this is very promising technology, and not just for women who cannot afford radiation or who live far from a radiation facility,” said Deanna J. Attai, MD, Center for Breast Care, Inc., in Burbank, Calif. “If this is proven to be as effective as radiation therapy, wholebreast or partial-breast, with fewer side effects and is much more cost-effective, this may quickly become the standard of care for women undergoing breastconserving therapy.”

The study was relatively small, but had a respectable follow-up, she said. “In addition, the number of patients actually exceeds the number in the initial FDA-approval trial for the MammoSite [Hologic] catheter.”

More data are needed before drawing conclusions, Dr. Attai added, noting that a multicenter registry trial is currently enrolling patients.

jcontinued from page 21

The Surgeon’s Challenge (from October 2012 issue) (Co-collaborator: Adam Bauermeister, MD, PGY1, Cleveland Clinic Florida, Weston) A 49-year-old man underwent laparoscopic longitudinal gastrectomy (sleeve) for morbid obesity (body mass index [BMI]: 40 kg/m2).

On postoperative day (POD) 1, the patient is recovering well and complaining only of mild abdominal tenderness. Upper gastrointestinal evaluation with Gastrograffin demonstrates no obstruction or leak, and duplex ultrasonography of the lower extremities indicate no deep vein thrombosis. The patient has mild hypotension and normal labs (complete blood cell count [CBC] and comprehensive metabolic panel [CMP]). The patient is advanced to a Phase I diet and a Foley catheter is discontinued. On POD 2, the patient is tolerating a diet, the hypotension has resolved, but he comments that he has unusual mild to moderate right buttock pain. On examination, the buttock is without erythema, induration or signs of infection. The rectal exam is normal; the urine output is adequate; and labs (CBC and CMP) are still within normal limits. What workup and further management should be performed at this stage of the patient’s hospital course?

Answer to Surgeons‘ Challenge This male patient recently underwent laparoscopic longitudinal gastrectomy for morbid obesity. On POD 2, the patient was recovering well and tolerating his Phase II diet. He complained of mild right buttock pain and stated that it felt as if he had pulled a muscle. The right buttock was tender on examination with no erythema or signs of infection. Due to a concern about a possible deep vein thrombosis (DVT), a duplex ultrasonography of the gluteal region was performed and was found to be negative. Serum creatinine phosphokinase (CPK) and myoglobin levels were ordered. CPK and myoglobin labs were significantly elevated (CPK: 3,536 IU/L; myoglobin: 57 µg/L). These symptoms and lab findings led to the diagnosis of rhabdomyolysis (RML). RML is an increasingly recognized and potentially fatal complication in morbidly obese patients who undergo long-duration surgeries.

RML occurs from injury to the skeletal muscle.

Subsequent release of myoglobin into the bloodstream can result in serious complications such as acute renal failure, disseminated intravascular coagulation (DIC) and local compartment syndrome.1 RML is believed to occur due to pressure injury to muscle during prolonged procedures. Risk factors include prolonged surgery time, nonphysiologic positioning (supine or lithotomy positions), inadequate padding and inadequate intraoperative hydration.2 Symptoms most commonly include numbness or pain in gluteal, lumbar or lower extremity muscles and/or oliguria.3 RML is diagnosed by

elevated CPK levels with a value five times greater than normal (>1,050 IU/L).4 The presence of myoglobinuria, found on examination or from lab reports, is an important supporting factor for the diagnosis of RML. Treatment of RML includes IV hydration, diuresis, alkalinization and correction of electrolyte abnormalities. Treatment for subsequent renal failure, DIC or compartment syndrome includes dialysis, treatment of coagulopathy and decompression.

Attention to postoperative complaints of pain, weakness, neuropathy, dark urine or oliguria should alert clinicians to the possibility of RML. Particularly, one should have increased suspicion in morbidly obese patients, who have a higher risk for developing this complication due to their excess weight.2 Diagnosis by serial serum CPK levels and aggressive therapy, started early, are recommended to prevent the potentially fatal complications of RML.

References 1. Hunter JD, Greg K, Damani Z. Rhabdomyolysis. Cont Educ Anaesth Crit Care Pain. 2006;6:141-143.

2. Khurana RN, Baudendistel TE, Morgan EF, et al. Postoperative rhabdomyolysis following laparoscopic gastric bypass in the morbidly obese. Arch Surg. 2004;139:73-76.

3. Torres-Villalobos G, Kimura E, Mosqueda JL, et al. Pressure-induced rhabdomyolysis after bariatric surgery. Obes Surg. 2003;13:297-301.

4. Mognol P, Vignes S, Chosidow D, Marmuse JP. Rhabdomyolysis after laparoscopic bariatric surgery. Obes Surg.

2004;14:91-94.

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Acute Care Surgery LD Britt; Andrew Peitzman; Phillip Barie; Gregory Jurkovich

June 4, 2012 This comprehensive textbook covers the related fields of trauma, critical care and emergency general surgery. The full spectrum of acute care surgery is expertly addressed, with each chapter highlighting cutting-edge advances in the field and underscoring state-of-the-art management paradigms.

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Atlas of Advanced Operative Surgery: Expert Consult—Online and Print

Vijay P. Khatri November 9, 2012 This new resource picks up where other surgical references leave off, providing highly visual, step-by-step guidance on more than 100 advanced and complex procedures in both general and subspecialty areas.

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

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General Surgery Board Review, Fourth Edition Larry A. Scher; Gerard Weinberg

October 17, 2011 This guide is indispensable for surgical residents and general surgeons preparing for the American Board of Surgery’s certification and recertification examinations. This study guide includes questions and answers after each chapter and succinct but detailed reviews of all topic areas found on the ABSITE and certification exam. There’s a new chapter on bariatric surgery and minimally invasive procedures.

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Surgical and Medical Management of Male Infertility Marc Goldstein; Peter N. Schlegel

December 31, 2012 For many years, the focus of fertility research and treatment has been the female. In reality, at least half of all infertility cases have a male factor as a major or contributing cause. With contributions from worldrenowned experts, this comprehensive overview of male infertility cove s anatomy, ers a ato y, evaluation, e a uat o , treatment t eat e t and a d prevention. p e e to

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The Business of Surgery

Eldo E. Frezza; MD April 13, 2007 A guide to the principles of establishing and maintaining a surgical practice.

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The Johns Hopkins ABSITE Review Manual

Susanna M. Nazarian; Robert A. Meguid; Pamela A. Lipsett July 14, 2008 This comprehensive manual covers all aspects of the ABSITE. This innovative text is broken up into two sections: The first features a full-length practice test based on actual key words from recent ABSITE exams, along with perforated answer sheets to simulate the real exam. The second section reviews all practice test questions and answers, providing rationales behind surgical decision making.

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Trauma, Seventh Edition

Kenneth Mattox; Ernest Moore; David Feliciano September 28, 2012 With a new full-color design and a rich atlas of anatomic drawings and surgical approaches, Trauma, 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.

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Video Atlas of Advanced Minimally Invasive Surgery: Expert Consult—Online and Print

Constantine T. Frantzides November 5, 2012 Video Atlas of Advanced Minimally Invasive Surgery y brings you the detailed visual guidance and unmatched expertise you need to master the most important and cutting-edge minimally invasive procedures and the treatment of unusual cases. Full-color photographs and narrated procedural videos online and on DVD lead you through today’s most effective techniques. Tips from a veritable “who’s who” in the field equip you to deliver optimal p results while minimizing g or avoiding g complications. p GSN1112

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Letters to the Editor

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

ER Call, Beeper Anxiety and Credit Rating To the Editor: [Re: "ER Call Ruined My Credit Rating," by Claire Cronin, MD, September 2012, page 4] I read with absolute pleasure the opinion article written by Dr. Claire Cronin in this issue. I laughed out loud multiple times, confusing my office staff who thought it was unusual to hear one of the docs actually laughing while they were still in the office. It made a nice break from the post-clinic torture that

is our electronic medical records system.

The sad part is that despite the tonguein-cheek method of delivery, the multiple real issues raised have become a daily source of frustration for the average surgeon in practice. Despite having to go back to the grim reality that has become our daily routine, and despite the fact that I am already starting to dread my night of ER call, I truly believe I will have a few more laughs today remembering the “Cronin Coincidence” and my

own “beeper anxiety,” as I trudge dutifully to my emergency room to provide another urgent surgical consultation for constipation in a 90-year-old, demented nursing home resident!

Charles Atkinson, MD, FACS Tucson, Arizona

To the Editor: I read with some disgust the article by Dr. Cronin. I have the following advice for her:

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surgeon preferred anatomical coverage and conformance…

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6.

7.

Hop off. Sounds like you should find a new line of work other than surgery.

Pay the bill. You stabbed yourself!

Learn how to insert a tube thoracostomy.

Take charge of the trauma resuscitation. If you had, you probably wouldn’t have stabbed yourself. a. Getting a chest X-ray during b. trauma code with no blood pressure? Where did you learn that? c. You describe a tension pneumothorax diagnosed by the emergency department doctor on chest X-ray. Wow! Take happy pills for your beeper anxiety.

It is fairly common knowledge that an incident report for a needlestick or other injury is required.

Remember, this was no one’s fault but your own. Take responsibility.

Lawrence Roberts, MD, FACS Fredericksburg, Virginia

To the Editor:

a new dimension in laparoscopic hernia repair.

I feel extremely sympathetic to Dr. Cronin’s situation. I had to deal with exactly the same problem: While taking care of a patient, I got a needlestick and could not go to employee health because it was closed. The OR [operating room] nurse filed an incident report and they sent me to the ER [emergency room] to get my blood drawn and a urine sample taken. I am a university employee, but despite that, I got a large bill for an “ER visit” that took several phone calls and trips to administrators to straighten out. While all that was happening, the bill was sent to collection. It was an unnecessary hassle to fix the issue, even though “hospital policy” was followed as indicated.

Mecker G. Möller, MD, FACS Miami, Florida

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

www.atriummed.com/c-qur © Atrium Medical Corporation 2012. All rights reserved. Atrium and C-QUR CentriFX are trademarks of Atrium Medical Corporation, a MAQUET GETINGE GROUP company.

I would laugh at this article but it makes me want to cry. I feel your pain.

Spencer Brown, MD Culver City, California

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

BARIATRIC SILS jcontinued from page 1

American Gastrointestinal and Endoscopic Surgeons (SAGES), Dr. Zorron said that it is too early to draw comparisons between bariatric SILS and NOTES and more traditional approaches, but the work needs to keep moving forward: “Our aim is to minimize the access. We are trying to do something less [invasive] for our patients, and [evolve] in our surgery,” he said.

Around 2007, Dr. Zorron, along with other surgeons, started using NOTES and SILS for cholecystectomy, among other procedures, and found generally favorable results with few complications.

“Now we are starting to do this for bariatric surgery for more complicated patients with more complex disease,” he said. “For now, we are doing more transvaginal and single-port sleeve gastrectomies, a simpler procedure than gastric bypass which will happen later, I think.”

‘The most important thing is that we think about how we can make a better surgery that will be referenced in the next 10 to 20 years.’

—Ricardo Zorron, MD, PhD Aside from the pioneering drive of surgeons, it is not clear what is driving the trend toward minimizing bariatric operations. Patient demand, for example, is not particularly high. Morbidly obese patients tend to be more concerned with the risks of surgery than with the cosmetic aftereffects of traditional laparoscopic surgery.

“It is not like in the beginning of laparoscopy when we had patients knocking on the door, wanting to do it that way,” Dr. Zorron said.

Bariatric surgery using NOTES and SILS presents a host of technical challenges to surgeons, such as limited motion and visualization. Surgeons can overcome some of these problems with increasingly sophisticated instruments, but the technology itself is evolving and, when available, is often quite expensive. Furthermore, surgeons who are already fully skilled in bariatric surgery would have to undergo additional training in these increasingly minimal approaches, but what could be a detractor for some is an exciting challenge to others: “It is the natural history of surgeons to try to do better, to get better. In the environment we work in, surgeons want to be on the cutting edge,” said Raul Rosenthal, MD, professor of surgery, Herbert Wertheim School of Medicine, Florida International University, Miami; chairman, Bariatric and Metabolic Institute; section head, Minimally Invasive Surgery,

Cleveland Clinic, Weston, Fla. “Then there is the technology that is made available to us, and the combination of surgeons who want to take advantage of that technology and start doing new things they hope will be better for the patient,” he aid. “However, there hasn’t been any proper scientific work done to validate that [SILS] is superior to other procedures.”

From Dr. Zorron’s point of view, if the work is not done today, there will be nothing to draw from tomorrow. “Laparoscopic surgery has to change because progress is expected. It is not the point to

develop instruments or [technology] that can be sold,” he said, noting that he did not have specific industry support during his 20 years of research in Brazil, where he worked until just a few months ago.

“I think the most important thing is that we think about how we can make a better surgery that will be referenced in the next 10 to 20 years.”

At present, bariatric NOTES hinges on the development of instrumentation— long staplers in particular. But surgeons have been using SILS to place gastric bands. “This is an operation that is simpler than others, and I’m sure we can do

it,” said Dr. Zorron, citing a study that showed, in a group of 22 patients, only one needed conversion to traditional laparoscopy and the results were good overall, with no intra- or postoperative complications (Surg Obes Relat Diss 2010;6:41-45).

One criterion for patient selection—a body mass index (BMI) range of 35 to 45 kg/m2—may have influenced the positive outcome, “but I think this is an approach that makes sense for these types of surgeries,” Dr. Zorron said.

With regard to sleeve gastrectomy, Dr. Zorron reiterated Dr. Rosenthal’s opinion see BARIATRIC SILS page 26

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In the News BARIATRIC SILS jcontinued from page 25

(which he shared at last year’s SAGES meeting) that the procedure is still evolving: Indications for sleeve gastrectomy are still in question; it is unknown whether patients will need a follow-up procedure; and there is a lack of long-term data.

Despite the challenges with exposure and visualization, skilled surgeons can satisfactorily perform sleeve gastrectomy via SILS, according to Dr. Zorron. The first prospective, randomized study comparing patients who received a laparoscopic

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

sleeve gastrectomy with five trocars, with patients who received a sleeve gastrectomy using only one, found more pain in the multiport group in postoperative days 1 and 2 (Obes Surgg 2011;21:1664-1670).

Overall, the extent of literature on SILS bariatric surgery is too limited to conclude whether or not there is a future for it. At present, this procedure costs more than traditional laparoscopic surgery; surgeons often have to add ports during a single-port procedure; and no strong data exist to indicate that it will improve patient outcomes.

However, Dr. Zorron supports

continued investigation of NOTES and SILS. “We cannot prove anything now.

Maybe we can prove it in 10 years, but if we don’t [study] this, we cannot prove anything or change anything,” he said. “I think progress is like this. It’s easy to criticize, and very hard to do.”

At present, he performs the majority of his bariatric procedures using traditional approaches, and offers SILS and NOTES procedures only to a small percentage of carefully selected patients. “I suffer to do this surgery. I take more time, I go home later,” Dr. Zorron said. “But I want to do progress in surgery—that is the point.”

Get concise medical education videos at your fingertips.

‘Personally, I might be a little biased; I don’t see any benefit. But at this point, it would be unfair to any hypothesis to say “this should not even be done in a randomized controlled trial.”’

—Raul Rosenthal, MD According to Dr. Rosenthal, no one should be performing NOTES or SILS bariatric procedures outside a randomized controlled trial with an institutional review board (IRB) protocol, and he suggested that the industry might be pressuring surgeons to move into territories as yet unproven and unsafe. “[There is the] perception that you’re missing something, that if you guys don’t do single incision, NOTES or [robotic surgery], you’re not going to be leading-edge. In five years, you’re not going to have a job,” he said.

Dr. Rosenthal also said that, without industry support, it is unlikely that anyone would experiment with approaches that are more challenging and expensive, offer no proven benefits in pain reduction or improved cosmesis, and that fly well under the radar of patients still impressed by traditional laparoscopy.

Furthermore, the challenges brought about by reducing the number of port sites to a single port, flouts one of the most important tenets of surgery—safety—starting with the compromised visibility and potential crossing of instruments. Dr. Rosenthal said, “The principles of safe surgery are traction and counter-traction, triangulation, dissection, critical view, control of critical structures, but with the exposure allowed by SILS, you can barely see anything. The principles of safe surgery, all basic principles, are gone with SILS.” The additional length of time it takes to perform SILS procedure is another safety issue that results in patients spending more time under anesthesia, Dr. Rosenthal said. “All these references tell you very clearly, the longer you’re under anesthesia, the more complications you can have.” More time on the operating table means greater cost, especially in the United States, and that cost is further driven by the expense of new technology.

“The little [scientific research] that has been done shows that [SILS] is of no benefit for the patient, could be detrimental, is more costly; and to some degree I believe that we should not be doing it until we have prospective, randomized controlled studies that show the reasons we should be doing it and when we should be doing it,” said Dr. Rosenthal.

This leads to the question of whether

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

there is any point in investigating SILS procedures even within prospective randomized trials.

“That is a good question,” Dr. Rosenthal said. “I think we have to be fair to the scientific process. Personally, I might be a little biased; I don’t see any benefit. But at this point, it would be unfair to any hypothesis to say, ‘this should not even be done in a randomized controlled trial.’ I would not take that away from any new approach.”

Eric DeMaria, MD, WakeMed Health and Hospital System, Raleigh, N.C., sides with the skeptic’s view when it comes to the pursuit of NOTES and SILS in bariatric procedures. “What we’re doing is really not tried, tested, vetted or endorsed as the appropriate standard of care,” he said, and the discussion raises more overarching questions.

“I’m really concerned about how we always seem to be innovating in bariatric surgery but never really seem to find the appropriate thing to do and stick with it,” he said. “Laparoscopic cholecystectomy was introduced, and created a dramatic change in our approach to cholecystectomy about 20 years ago, but it hasn’t changed very dramatically since then.

In contrast, bariatric interventions seem to be continuously evolving and changing and never quite reach the point of standardization.”

Dr. DeMaria agrees with the notion that surgeons are innovators by nature, always problem solving and trying to figure out a modification that will improve outcomes or cut down on length of procedure, but this comes down to a matter of degree.

“I don’t think it’s such an issue if you’re looking at a question of, say, changing what suture material you use or how you perform the suturing,” he said. “Tremendous variability occurs in surgery because you can’t always do things the same way. Unfortunately, in bariatrics, we also seem to regularly come across novel procedures, or access concepts that many people begin to apply without proving those concepts with any sort of prospective research approach.”

In some cases, this approach begins to blur the fine line between innovation and human experimentation, Dr. DeMaria said. “That may seem strong language, but at some point in the continuum you go from modification to innovation to human experimentation. Human experimentation has led to tremendous advances, but it has also caused harm.”

Bariatric SILS has not been proven to demonstrate desired outcomes, but there may be some subtle benefits, said Dr. DeMaria. “One that I often hear argued is that the reduced invasiveness of single incision encourages patients to come forward for surgical treatment who might not have been comfortable with it before.”

Additionally, there is no schematic for location and number of incisions that laparoscopic surgeons place. For years, Dr. DeMaria has placed fewer incisions for laparoscopic procedures when the individual case has warranted doing so.

“The question is can you push from four to six incisions to a single incision safely and talk about this being advantageous when you don’t have the data to back that up?” he said.

A greater criticism of the field of surgery, however, is that there is no standard system for adopting new approaches, even if they have been tested and found

beneficial.

“I’ve lived through two eras in surgery where I know for a fact that patients were injured by the lack of an appropriate, careful system for introducing new concepts in surgery,” said Dr. DeMaria.

The first era was the introduction of laparoscopic cholecystectomy, and the second was the beginning of laparoscopic gastric bypass.

“Bariatric surgery took such a black eye from highly publicized complications that it almost fell into disfavor and may not have existed if things had

continued for another couple of years in the same direction,” Dr. DeMaria said.

“It’s really about time that we in minimally invasive surgery, and bariatrics in particular, figure out a way to offer and train surgeons well, to perform standard procedures and not be so tolerant of disruptive innovation,” he said.

“Our bariatric population is so vulnerable to being misled and convinced that a ‘great’ new concept could save them from their disease. We have to be more responsible because we have a population that’s willing to sign up for anything that will help.”

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

Surgery Reverses Diabetic Nephropathy in Almost 60% of Patients Researchers, Expecting a Halt in Progression After Bariatric Surgery, Instead See Remission B Y C HRISTINA F RANGOU SAN DIEGO—Bariatric surgery induces a significant and lasting improvement in diabetic nephropathy, with nearly 60% of patients with this condition achieving remission five years after surgery, according to a study presented at the 2012 annual meeting of the American Society for Metabolic and Bariatric Surgery.

The investigators say that the finding demonstrates a previously unknown microvascular effect of bariatric surgery.

“When we started this study, we thought bariatric surgery may just halt the progression of diabetic nephropathy.

Instead, over half the patients who had diabetic nephropathy prior to undergoing bariatric surgery experienced remission,” said lead author Helen M. Heneghan, MD, a bariatric surgery fellow at Cleveland Clinic Bariatric and Metabolic Institute, in Ohio.

Dr. Heneghan said the finding warrants

greater consideration of bariatric surgery in patients with diabetic kidney disease. However, she said, more studies with larger numbers of patients are still needed to confirm the results.

Dr. Heneghan and her colleagues examined the five-year outcomes of 52 diabetic patients who underwent bariatric surgery at the Cleveland Clinic. Of these patients, 75% were women. They had a mean age of 51.2 years (±10.1 years) and a preoperative body mass index of 49 kg/ m2 (±8.7 kg/m2).

Before their operations, 37.6% of patients had diabetic nephropathy, as indicated by microalbuminuria (30-299 mg/g creatinine) or macroalbuminuria (>300 mg/g creatinine). After bariatric surgery, nephropathy resolved in 58.3% of the patients at a mean follow-up of 66 months.

Patients with microalbuminuria and those with macroalbuminuria experienced similar improvements in nephropathy. For patients with microalbuminuria, 42% remained stable five years after surgery and 58% had a regression of their nephropathy. Half of the patients with macroalbuminuria remained stable and half experienced

“No medical therapy has been as effective in achieving an effect of this magnitude on diabetic nephropathy.”

—Philip R. Schauer, MD regression. No patient with nephropathy worsened or required dialysis.

For patients with no evidence of diabetic nephropathy prior to bariatric surgery, 75% remained without nephropathy after five years whereas the remaining 25% progressed to microalbuminuria.

“No medical therapy has been as effective in achieving an effect of this magnitude on diabetic nephropathy,” said study co-author Philip R. Schauer, MD, professor of surgery and director of Cleveland Clinic Bariatric and Metabolic Institute.

Similar to previous studies, bariatric surgery’s effect on diabetes was strongly dependent on the amount of

weight loss. The patients with the greatest weight loss had the best results in terms of diabetes improvement in this study.

Overall, diabetes resolved in 44% of patients, who averaged a mean weight loss of 92.3 pounds. One-third of patients experienced an improvement in their diabetes; these patients lost an average of 77.8 pounds. And patients who see NEPHROPATHY page 31

Appendectomy Delay Increases Surgical Site Infection Risk B Y G EORGE O CHOA

A

delay of more than six hours from the time of admission to the time of appendectomy was associated with an increased risk for surgical site infection (SSI) among patients with nonperforated appendicitis, according to a study in Annals of Surgery (2012;256:538-543).

The paper’s lead author, Pedro G. Teixeira, MD, surgical critical care fellow, Department of Surgery, University of Southern California (USC), Los Angeles County (LAC) + USC Medical Center, in Los Angeles, told General Surgery News, “As a surgical community, we’ve attempted to decrease the rate of complications. SSIs have been used as a marker of quality care delivery. Identifying somethiing that we do that increases the rate of SSIs is very rellevant.”

In the retrospective study, the records of patients admitted with appendicitis to LAC+USC C Medical Center from July 2003 to June 2011 1 were reviewed. Over the eight-year period, 4,529 patients were admitted with appendiccitis and 4,108 (91%) underwent appendecctomy. Perforation occurred in 23% (942)) of the patients who received appendectomyy. A delay to appendectomy was not associatted with a higher perforation rate.

After adjusting for age, leukocytosis, sex, surgical technique (open vs. laparoscoopic) and perforation, the time from admission

to appendectomy (time to appendectomy) greater than six hours was independently associated with an increase in SSI (odds ratio [OR], 1.54; 95% confidence interval [CI], 1.01-2.34; P=0.04). Time to appendectomy did not significantly increase SSI risk in patients with perforated appendicitis, but it did so in patients without perforation. A delay of greater than

'Our paper suggests that expediting surgical intervention is appropriate. It may not be appropriate to wait more than six hours.'

—Pedro G. Teixeira, MD

six hours resulted in a significant increase in SSI from 1.9% to 3.3% in patients with nonperforated appendicitis (OR, 2.16; 95% CI, 1.03-4.52; P=0.03], such that the incidence of SSI in nonperforated appendicitis reached a level similar to that with perforation (3.3% vs. 3.9%; P=0.47).

The average time from admission to appendectomy was 11 hours and 50 minutes. Dr. Teixeira noted that this was “a little long,” although 36% of patients were operated on within six hours.

“There are several reasons for a delay,” he said.

“Because some data show that a delay is acceptable, some surgeons are reassured that it wouldn’t negatively affect the outcomes. Also, we have a very busy hospital, and even though it is open 24/7, in some cases p mu ultiple trauma patients might affect the timing and cau use a delay.”

JJohn E. Mazuski, MD, PhD, professor of surgery, Waashington University School of Medicine, in St. Loouis, who was not associated with the study, wrote by email: “This is an important paper from several standpoints. A key point is that it is a very large, albeit rretrospective study.” The important conclusions, he stated, are “that appendiceal perforation is not directly rrelated to timing of appendectomy” and “that there waas an important consequence to a delay in appendectomy, which is an increase in infectious risk.”

Dr. Mazuski noted several limitations of the study, inccluding the use of a composite end point for SSI thaat “does intermix complications which may be of see APPEN DECTOMY page 31

GSN Bulletin Board

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2012

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The Division of General Surgery at the University of Washington School of Medicine is seeking applications for a full-time non-tenured faculty position in the Urgent Care Surgery section at the rank of Acting Instructor or Assistant Professor or Associate Professor, depending on the applicant’s credentials. This position will be on a service with three other attending surgeons and will be based primarily at the University of Washington Medical Center. The main responsibilities are to develop a general surgery practice, with a focus on urgent surgical consults and referrals, and to participate in the teaching of surgical residents, medical students, and division fellows. They are expected to develop an area of scholarly expertise, as expected of every faculty member, in consultation with the Division and Section Chief. The University of Washington Medical Center is a nationally recognized academic medical center offering outstanding specialty and primary care. UW faculty engage in teaching, research, and service. The candidates must have an MD (or equivalent) and be board certified or board eligible (or equivalent) in surgery. In order to be eligible for University sponsorship for an H-1B visa, graduates of foreign (nonU.S.) medical schools must show successful completion of all three steps of the U.S. Medical Licensing Exam (USMLE), or equivalent as determined by the Secretary of Health and Human Services.

The University of Washington is an affirmative action, equal opportunity employer. Applicants should submit their curriculum vitae, a cover letter, and references to:

Brant K. Oelschlager, MD Byers Endowed Professor in Esophageal Research Department of Surgery, General Surgery Division University of Washington 1959 NE Pacific Street, Box 356410 Seattle, Washington 98195-6410 Email: brant@uw.edu

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NEPHROPATHY

APPENDECTOMY

had no improvement in diabetes showed the least weight loss, an average of 27.5 pounds after five years. They also had the highest levels of HbA1c (glycosylated hemoglobin) five years after surgery at 7.9%, in contrast to 5.9% among those with resolved diabetes and 6.9% among those with improvements in diabetes.

The investigators found no preoperative differences in the mean urinary albumin levels between patients who were prescribed a renoprotective agent and those who were not. However, postoperatively, patients who were not on an angiotensin-converting enzyme inhibitor had lower levels of albuminuria (within normal range) compared with those who remained on a renoprotective agent (P=0.039).

P

different importance” as well as the restriction to the experience of a single public hospital.

“Another limitation with the paper is the way in which delay of appendectomy was measured,” he said. “The time recorded is that between hospital admission and appendectomy, but neither of these is precisely characterized. … [Another] major potential limitation is the lack of data on antibiotic usage relative to the delay. …

jcontinued from page 28

Malabsorptive procedures were associated with a trend toward higher rates of remission of diabetes and nephropathy.

“This probably reflects the fact that patients who had improvement of their diabetes and regression or non-progression of their nephropathy status also had a significant improvement or remission of hypertension, and were no longer prescribed an antihypertensive medication,” said Dr. Heneghan.

In a discussion following the presentation, several surgeons asked if the type of bariatric procedure influenced nephropathy outcomes. One surgeon suggested that the duodenal switch, with its high reported rates of resolution of diabetes and improvement in hemoglobin C1 levels, may offer the best chance of improving diabetic nephropathy.

However, the study was too small to detect any differences in diabetic nephropathy based on bariatric procedure and no patient underwent a duodenal switch in the study, said Dr. Heneghan.

Sixty-nine percent of patients underwent gastric bypass, 3% had sleeve and the remainder underwent laparoscopic gastric banding.

Malabsorptive procedures were associated with a trend toward higher rates of remission of diabetes and nephropathy, although the difference from other procedures was not significant.

“This study would suggest that gastric bypass would probably be the most effective procedure,” said Dr. Heneghan.

“In our institution, we recommend a gastric bypass in patients who have obesityassociated diabetes.”

jcontinued from page 28

Were the patients experiencing a significant delay (>6 hours) being treated with antibiotics?”

Regarding how the study should affect clinical practice, Dr. Teixeira said, “Our paper suggests that expediting surgical intervention is appropriate.

It may not be appropriate to wait more than six hours.”

“I think it would be premature to suggest that practice patterns should be altered based on the findings of this study,” Dr. Mazuski countered. “To bring the performance of appendectomy down to the suggested six-hour time

point … would probably require a significant increase in resources just for this one disease process.” The “role of antibiotics in permitting a safe delay in appendectomy” needs to be addressed with further research, he said.

Dr. Teixeira reported no relevant financial conflicts of interest. Dr. Mazuski reported receiving research funding and serving as a consultant and speaker for several pharmaceutical companies making antibiotics that can be used in the treatment of intra-abdominal infections, including AstraZeneca, Forest Laboratories, Merck and Pfizer.

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Clinical Experience Using

Multifunctional LigaSure™ Small Jaw Instrument in Vessel Sealing Procedures Faculty:

Introduction

Ellie Maghami, MD, FACS Associate Professor of Surgery Chief, Division of Otolaryngology/ Head and Neck Surgery City of Hope National Medical Center Duarte, California

What do endocrine and head and neck surgeons want in an energy-based vessel sealing device? “Something that is easy and safe to use, won’t harm any neighboring structures, effectively seals lymphatic vessels and minimizes bleeding, is easy to set up and use by the nursing staff, and is relatively inexpensive,” said John L. Crawford, MD, surgeon at Texas Health Harris Methodist Hospital in Fort Worth.

According to Paolo Miccoli, MD, Italian director of surgery at Azienda OspedalieroUniversitaria Pisana in Pisa, Italy, a welldesigned vessel sealing device can offer several advantages. “We could obtain optimal coagulation and cutting, and separate the vessels with the same instrument. This way we do not need to clamp and tie, which could reduce the length of the operation by at least 30%,” he said. “Another advantage would be to make operating more precise and accurate, with a reduction in blood loss.”

Taking into consideration such input from surgeons, Covidien introduced a new member to the LigaSure™ family of cutting and sealing devices—the new LigaSure small jaw instrument—designed to increase ease of use and enhance safety in the operating room. The LigaSure small jaw instrument features an integrated blade that can be activated independent of sealing. The new device is multifunctional, capable of blunt dissection and grasping, and has a low thermal profile, thus reducing the risk for inadvertent burns (Figure 1).

John L. Crawford, MD, FACS Department of Endocrine Surgery Texas Health Harris Methodist Hospital Fort Worth, Texas Paolo Miccoli, MD Italian Director of Surgery Azienda OspedalieroUniversitaria Pisana Pisa, Italy Neil Tolley, MD Consultant ENT and Thyroid Surgeon St. Mary’s Hospital London, United Kingdom TO LEARN MORE ABOUT THE LIGASURE™ SMALL JAW, CALL 1-800-255-8522

Use scan app to read Distributed by McMahon Publishing

Multifunctionality and Need-Based Approaches Prior to adopting LigaSure technology, Ellie Maghami, MD, associate professor of surgery and chief of otolaryngology at City of Hope National Medical Center in Duarte, California, used the clamp-and-tie approach for neck dissection. “I would clamp the lymphatic bundles, divide the tissue, and tie off each individual bundle one by one,” she said. “That obviously takes some time.”

She finds the LigaSure small jaw instrument ideally suited to speed up this task. “I like it for neck dissections quite a bit.

A lot of the neck dissections I do are for very advanced bulky disease in the neck where I come across a lot of lymphatics. This [instrument] allows you to quickly sweep through the lymphatics and save some time, especially when operating with a single assisting resident surgeon-in-training.”

Dr. Maghami also finds the LigaSure small jaw instrument helpful when operating on patients who have previously undergone treatment for cancer. “I do a lot of post-chemoradiation neck dissections for recurring cancer,” she said. “The anatomy in the reoperative cases often is distorted by tumor or dense scar tissue, so it helps to have an instrument that allows you to navigate through soft tissue in a fast and reliable way.

That is how I use LigaSure in my practice, in my hands, most efficiently.”

Dr. Crawford has used LigaSure technology to seal and cut blood and lymph vessels, divide mesentery in bowel surgery,

REPORT and perform splenectomies and thyroidectomies. Prior to adopting the LigaSure™ small jaw instrument, Dr. Crawford and his team used the Harmonic FOCUS™*, which they found could be problematic. “We were frustrated because the Harmonic FOCUS took us longer to set up. I had a lot of trouble with the device not working or the energy unit breaking intraoperatively, and I was concerned about energy getting too far out from the probe. The tissue seemed to be coagulated further out from the jaws of the instrument and we were concerned about using it too close to nerves,” he said.

“We don’t use cautery next to the recurrent laryngeal nerve or the external branch of the superior laryngeal nerve during thyroid or parathyroid surgery, so the [LigaSure small jaw instrument] had a nice niche. We started using it and liked it immediately,” Dr. Crawford said. Additionally Dr. Crawford prefers the way the LigaSure small jaw instrument cuts as compared with the Harmonic FOCUS. He noted, “The smooth cutting device built into the LigaSure small jaw instrument allows me to moblize the upper pole of the thyroid gland during a thyroid lobectomy much more quickly than with the Harmonic FOCUS. With the FOCUS, I often have to switch to scissors to cut the tissue, then go back to the FOCUS to continue the dissection.”

Neil Tolley, MD, a consultant ear, nose, and throat, and thyroid surgeon at St. Mary’s Hospital in London, who performs 5 to 10 thyroid/parathyroid surgeries per week, tried LigaSure technology 5 or 6 years ago, but did not find it compatible with the energy platform he was using at the time.

When the ForceTriad™ energy platform became available he tried again with the LigaSure technology. “Although we still had to go through the second maneuver—picking up the scissors and cutting the part that was sealed—I gave up the Harmonic scalpel and went to the LigaSure [small jaw],” he said. “I found the LigaSure [small jaw instrument] ergonomically easier to use and more suited to the confined environment associated with head and neck surgery and, in particular, thyroid surgery through a small incision.”

Dr. Tolley found the LigaSure technology to be more reliable and consistent than instruments he had used in the past. “The Harmonic scalpel has a learning curve; you have to learn about its limitations in vessel sealing. The LigaSure [small jaw] is superior for sealing thin-walled vessels such as veins. I found the Harmonic less reliable for sealing larger caliber veins,” Dr. Tolley said.

Table 1. Comparison Between the Clamp-and-Tie Method and LigaSure™ Small Jaw Instrument Operating Time

2

Conventional Group

LigaSure Group

P-Value

Lobectomy (min) 67.25±4.49

37.65±4.68

<0.0001

Subtotal thyroid- 101.20±7.51 ectomy (min)

66.80±4.56

<0.0001

Total thyroidectomy (min)

132.13±7.50

93.16±5.68

<0.0001

Length of incision (cm)

9.11±1.38

9.02±1.50

0.505

Intraoperative blood loss (mL)

132.72±28.38

65.60±14.79

<0.0001

Based on references 1-5.

Figure 1. LigaSure™ Small Jaw Instrument with ForceTriad™ Energy Platform.

Dr. Tolley also preferred the cooler temperature profile of the LigaSure technology. “You have to be careful with the active blades [when working with other instruments]—if you just touch the skin you will get a burn,” he said. “Of course, what we really wanted was the LigaSure technology with an integrated blade. That came on the market in January in the United Kingdom. I haven’t looked back since.”

Reduced Operating Time Studies have shown that the use of LigaSure technology in head and neck surgery results in reduced blood loss, less postoperative pain, and reduced hospital length of stay compared with conventional techniques.1 In a study of 110 patients with thyroid disease, Youssef and colleagues found that postoperative blood loss was reduced by approximately 67 mL in the LigaSure group (P<0.0001) and that operating time was reduced by roughly 30 minutes (P<0.0001). There was a significant reduction in reported pain and analgesic use with LigaSure. Additionally, patients in the LigaSure group were able to return to activity and work without pain sooner than patients in the conventional group. The most consistently noted benefit, however, has been reduction in operating times (Table 1).1-5 Surgeons using the LigaSure small jaw instrument are finding that its multifunctionality and integrated blade might contribute to the reduced operating time, eliminating the need to reach for separate instruments.

Dr. Maghami was quite pleased with the first-generation LigaSure Precise™ instrument. “I liked that instrument because it somewhat mimicked the tonsil dissector we use in head and neck surgery. But it did not have cutting integrated, and in surgery that often translates into additional time spent for instrument exchanges,” she said.

“By integrating [a] cutting function into the new device, efficiency is enhanced.”

Noting the well-documented coagulating capacity of radiofrequency technology, Dr. Miccoli considers the ability to cut and coagulate with one instrument an important advance.6 “The main advantage acquired with the new LigaSure small jaw instrument is the ability to cut with great precision the vessels that have been coagulated,” said Dr. Miccoli, who has been using LigaSure technology for the past decade; nearly 3,000 thyroidectomies per year are performed at his center.

“Using this instrument allows you full control over the surgical procedure, which is not only time saving, but also makes you more comfortable with the procedure; that is the most important thing.”

REPORT

Figure 2. Thermal imprint comparison of the Ligasure™ Small Jaw Instrument and the Harmonic FOCUS™*.

Temperature Profile The design of the LigaSure™ small jaw instrument, with a relatively cool temperature profile and insulated tip, is meant to confine effects to the target tissue and minimize the risk for thermal spread to surrounding tissues. “One of the reasons nerve damage occurs is transmission of heat, so the capacity of controlling better heat transmission means less [risk for] heat injuries to the nerve,” Dr. Miccoli said.

The mean maximum external jaw temperature ranges of the LigaSure small jaw instrument during a procedure are lower than those of Harmonic FOCUS. During a single activation for sealing an isolated vessel, the LigaSure small jaw instrument achieves temperatures of 60°C to 95°C, compared with 178°C to more than 250°C for the Harmonic FOCUS. On average, the external jaw temperature of the LigaSure small jaw instrument was at most 155°C cooler than the Harmonic FOCUS (Figure 2).7 “I think that what has been considered low temperatures, less than 100º [Celsius], can be very harmful to critical structures,” Dr. Miccoli said. “So we should not exceed 40° or 50° [Celsius] when close to critical structures. Since radiofrequency generally does not exceed 60° to 70° [Celsius], I think we are [getting] close to the ideal instruments.”8 The LigaSure small jaw instrument takes just up to 5.4 seconds to cool down to less than 60°C after a single activation on isolated vessels, whereas the Harmonic FOCUS may require at least 10 to as many as 60 seconds to cool down to 60°C. The LigaSure small jaw instrument seals effectively at cooler temperatures compared with the Harmonic FOCUS (Table 2).7 The cooler temperature profile is an attractive feature to head and neck surgeons for a variety of reasons.

For one, there is less risk for personal injury or for inadvertent burns to the patient. More importantly, this lowers the risk for injury to the critical and sometimes delicate structures in the head and neck.7,9 “You can help avoid thermal injury to very important structures like the recurrent laryngeal nerve, the very delicate parathyroid glands, the trachea, the esophagus, and the skin, as well as the drapes.” Dr. Crawford said. The lateral heat spread of previous instruments was of concern to Dr. Tolley, as it may have been larger than the expected 2 mm, he said.

“The Harmonic device gets very hot, and you really appreciate how significant this is, in my opinion, when you’re assisting someone else.”

Dr. Tolley found that instruments he used in the past were prone to cause small burns to the patient’s skin. “When you take the instrument out of the wound, you may get a little burn on the skin,” he said. Although the burns were not third degree, they could still scar. “When you’re operating, sometimes you’re ‘micro-focusing.’ You’re really looking very carefully at a structure and you may not be aware of what is happening in the more generic use of the instrument,” Dr. Tolley said.

“You’re cutting with the tip, but you may be touching the skin or other structures with the part of the instrument you are not focused on.”

Dr. Maghami appreciates the confidence she has that the instrument in her hand will allow her to focus without the concern of another area being at risk. “Both tips of the [LigaSure] instrument are guarded, and it functions like a bipolar instrument in the sense that you have thermal energy between the tips and nowhere else,” she said.

“With the Harmonic scalpel, one end of the blade is uncovered and it gets very hot. Throughout the application, you have to be very mindful of where you’re putting that end of the instrument, and in proximity to what structure you are engaging it,” Dr. Maghami said. “[With the application of the jaws], you must be careful not to place the hot tine near critical neurovascular structures during thyroid surgery. With the LigaSure device you really don’t have that [concern] to the same degree. It’s much safer, especially in a training program where you’re educating relatively novice surgeons [about the] application of these technologies. One must constantly remind young residents of the heat polarity of the tines in the application of the Harmonic scalpel. This is not necessary with the LigaSure.”

Vessel Sealing and Sutureless Surgery Used with the ForceTriad energy platform, LigaSure technology provides a continuous output of energy, making 3,333 adjustments per second to seal vessel walls (Figure 1).

The LigaSure small jaw instrument can seal vessels up to 7 mm. Lamberton and colleagues studied the burst pressure

Table 2. Temperature Comparison of LigaSure™ Small Jaw and Harmonic FOCUS™* Mean Maximum External Jaw Temperature Ranges During Operation

LigaSure Small Jaw

Harmonic FOCUS

Single activation for sealing isolated vessels

60-95°C

178->250°C

1-7 mm diameter

1-5 mm diameter

Single activation for mesentery dissection

55-61°C

194->250°C

Minimum time to achieve device cool down (temperature <60°C) after single activation on isolated vessels

0-5.4 sec

10.2-60 sec

Multiple activations (10) for mesentery dissection

78-82°C

>250°C

Minimum time to achieve device cool down (temperature <60°C) after multiple activations (10) on mesentery

17-33 sec

53-83 sec

3

Conclusion Although surgeons might be inclined to quickly adopt an instrument that offers clear advantages in terms of patient outcomes and their own satisfaction, hospital directors and materials managers, too, need to be convinced of the benefits of a new technology before the instrument can debut in the operating room. Increased efficiency with LigaSure technology could offset the cost of its use.5 “A high-volume hospital should acquire new technologies because it is in the position of offering the best quality, both to the surgeons and their patients,” Dr. Miccoli said. “I think it could be beneficial for hospitals to acquire this instrument,

4

500 450 400 350 300 250 200 150 100 50 0

Mean Burst Pressure 386

204

Harmonic Scalpel

LigaSure

Figure 3. Comparative mean burst pressure between Harmonic™* and LigaSure™ products.

Adapted from reference 10.

which is an objective improvement over the previous instruments.”

For Dr. Tolley, adoption of the LigaSure small jaw instrument makes sense clinically and economically. “There are factors limiting the number of cases you can do, but if you can operate faster, there will be more patient turnover, which economically benefits both the hospital and the surgeon. Furthermore, and more to the point, increased vessel sealing reliability will enhance patient safety.”

References 1.

Youssef T, Mahdy T, Farid M, Latif AA. Thyroid surgery: use of the LigaSure Vessel Sealing System versus conventional knot tying. Int J Surg. 2008;6(4): 323-327.

2.

Cakabay B, Sevinc MM, Gomceli I, Yenidogan E, Ulku A, Koc S. LigaSure versus clamp-and-tie in thyroidectomy: a single-center experience. Adv Ther.

2009;26(11):1035-1041.

3.

Yao HS, Wang Q, Wang WJ, Ruan CP. Prospective clinical trials of thyroidectomy with LigaSure vs. conventional vessel ligation: a systematic review and meta-analysis. Arch Surg. 2009:144(12):1167-1174.

4.

Leptner U, Vaasna T. LigaSure vessel sealing system versus conventional vessel ligation in thyroidectomy. Scand J Surg. 2007;96(1):31-34.

5.

Saint Marc O, Cogliandolo A, Piquard A, Fama F, Pidoto RR. LigaSure vs. clamp-and-tie technique to achieve hemostasis in total thyroidectomy for benign multinodular goiter: a prospective randomized study. Arch Surg.

2007;142(2):150-156.

6.

Manouras A, Markogiannakis H, Koutras A, et al. Thyroid surgery: comparison between the electrothermal bipolar vessel sealing system, harmonic scalpel, and classic suture litigation. Am J Surg. 2008;195(1):48-52.

7.

Data on file, Covidien.

8.

Kim FJ, Chammas MF, Gewehr E, et al. Temperature safety profile of laparascopic devices: Harmonic ACE (ACE), Ligasure V (LV), and plasma trisector (PT). Surg Endosc. 2008;22(6):1464-1469.

9.

Smith CT, Zarebczan B, Alhedfdhi A, Chen H. Infrared thermographic profiles of vessel sealing devices on thyroid parenchyma. J Surg Res. 2011;170(1):64-68.

10.

Lamberton GR, Hsi RS, Jin DH, Lindler TU, Jellison FC, Baldwin DD. Prospective comparison of four laparoscopic vessel ligation devices.

J Endourol. 2008;22(10):2307-2312.

For more information go to: Covidien.com/EnergySolutions.

COVIDIEN, COVIDIEN with Logo, Covidien logo and positive results for life 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. M120920 2012/11.

Disclaimer: This monograph is designed solely to provide the health care professional with information to assist in his or her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the health care professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. Covidien, the authors, the coordinators, the reviewers, and the McMahon Publishing specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through the reader’s misunderstanding of the content.

SR1128

of several vessel sealing devices. As compared with the Harmonic device, LigaSure™ was observed to have a higher burst pressure, indicating better vessel sealing (Figure 3).10 Dr. Tolley is confident that the LigaSure small jaw instrument can seal any vessel he encounters in head and neck surgery.

“You need to have the best and most reliable means of sealing the vessels. If you have a bleed, the patient will have to go back to surgery. They may end up with long-term brain damage, which has huge consequences to the patient and the hospital in terms of litigation,” Dr. Tolley said. “For all the vessels that you encounter [in head and neck surgery], the LigaSure small jaw is fit for the purpose,” he continued.

Dr. Crawford has the utmost confidence in the LigaSure small jaw instrument. “I think it’s been [very] consistent. Just last week for the first time I did a total thyroidectomy on a gentleman who is HIV- and hepatitis B–positive and I didn’t use any sutures,” he said.

Ergonomically, the LigaSure small jaw instrument may offer some advantages to head and neck surgeons, particularly those who use the clamp and tie approach for neck dissection. “Before energy devices, we used to clamp and tie,” Dr. Miccoli said. “Reaching a more limited space was ergonomically unfriendly. This changed the economy of the surgical gesture.”

Dr. Maghami clamped, divided, and tied her way through residency and fellowship. “But as an attending and going through cases with a single surgical resident assisting, it became a bit cumbersome,” Dr. Maghami said. “So I started experimenting with the [LigaSure] small jaw instrument, and it seemed to be an efficient and reliable device.”

Dr. Tolley appreciates the shorter length of the LigaSure small jaw instrument for working in confined areas. “For example, [some devices are] not designed for head and neck work, whereas the LigaSure has been specifically designed for use in the head and neck.”

Ergonomically, the LigaSure small jaw instrument has an edge over devices such as the Harmonic FOCUS, according to Dr. Crawford. “It’s smaller, it’s lightweight, and it’s nice because it has that cutting device [incorporated].”

mm Hg

REPORT