The History of Bariatric Surgery: Introducing a New Bariatric Procedure: Clinical Trials of Gastric Banding

| October 8, 2015

by Paul O’Brien, MD, FRAS

Dr. Paul O’Brien is the head of the Centre for Bariatric Surgery in Melbourne, Australia, and Emeritus Professor of Surgery at Monash University. He was Head of the University’s Department of Surgery at the Alfred Hospital from 1986 to 2004. He founded the Centre for Obesity Research and Education (CORE) at Monash University in 2004 and is its Emeritus Director. He is also the National Medical Director of True Results, a multicenter, outpatient bariatric clinical facility based in Texas. His current principal areas of clinical and research interest are the morbidity of obesity and the health benefits of weight loss. He is a former Co-Editor-in-chief and is now Advisory Editor for the journal Obesity Surgery. Dr. O’Brien is a world leader in laparoscopic adjustable gastric banding. He was involved in the design and testing of the Lap-Band in the early 1990s and he placed the first Lap-Band in Australia in 1994.

Bariatric Times. 2015;12(10):20–22.


 

This column is dedicated to telling the stories of leaders who have helped shape the field of bariatric surgery through their discoveries, teaching, and stewardship.

Column Editor: George L. Blackburn, MD, PhD, FACS
S. Daniel Abraham Professor of Nutrition; Associate Director, Division of Nutrition Harvard Medical School; Director, Center for the Study of Nutrition Medicine, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts

Column Editor: Daniel B. Jones, MD, MS, FACS
Professor of Surgery, Harvard Medical School, Vice Chair, Beth Israel Deaconess Medical Center, Boston, Massachusetts

A Message from the Column Editors
Dear Readers of Bariatric Times:
Bariatric surgery has many leaders who have shaped the field by their discoveries, teaching, and stewardship. In this column, we invite leaders to tell us about their most significant accomplishment(s). Here, we will hear from leaders about their visions, hurdles, collaborations, and, ultimately, what impact their accomplishments have had on the field of bariatric surgery. We will also learn how they set goals and have turned ideas into reality, as well as what was anticipated and what was not expected throughout their journeys.
We are very excited about this project and hope it will help to inspire the next generation of leaders as they evaluate new devices and technology and consider novel procedures and treatments in an era of cost containment. We hope you enjoy these stories.

Sincerely,
Drs. George L. Blackburn and Daniel B. Jones


The birth of a new surgical procedure is rarely smooth. You start with an idea, build a model, and then start to solve numerous challenges. Once the procedure seems to be functioning reasonably, you perform clinical trials to work out the optimal techniques, measure how well it works, and define the side-effects. The story I want to tell is about some of that testing for the laparoscopic adjustable gastric band (LAGB).

The idea of the LAGB was derived from animal studies of an adjustable gastric band developed by Dr. Gerhard Szinicz and co-workers from Austria beginning in 1979.[1,2] Dr. Szinicz has gone on to an illustrious career as a professor of surgery and a leader of minimally invasive abdominal surgery in Austria. His model was brought into clinical practice as open surgery by Dr. Lubomyr Kusmak[3] in the United States and Dr. Peter Forsell in Sweden[4] during the 1980s and then modified to enable laparoscopic placement in the early 1990s.

These were exciting times. Many abdominal surgeons had felt blind-sided by the introduction of laparoscopic cholecystectomy, and we went headlong in search of the next breakthrough laparoscopic procedure. In 1991, I collaborated with the BioEnterics Corporation, who held the rights to the Kusmak band, to help create a laparoscopic option for the bariatric surgeon. They also worked closely with Mitiku Belachew, a gentle and thoughtful surgeon from Huy, Belgium. After some preliminary animal experimentation, Mitiku and his colleague, Marc Legrand, placed the first LAGB on September 1, 1993. The ball was now in play and surgeons across Europe, and me and my friend, Harry Frydenberg in Melbourne leapt into clinical practice within a relative knowledge vacuum. Not surprisingly, some of these early results were disappointing.[5]

Nevertheless, it was clear from those early days that the band worked. From the start, we had very good weight loss in some patients and acceptable weight loss in most. We saw the health benefits and the improved quality of life. But there were lots of early troubles. We needed to know more, and being an academic surgeon, I took on as much of a role as I could in contributing to that knowledge.

I had had the enormous benefit of working for two years with Dr. William Silen at the Beth Israel Hospital in Boston, Massachusetts, in the early 1970s. He was a predecessor of our distinguished Column Editor, Dan Jones. Bill Silen taught me many things, but most importantly he taught me an underlying principle—if you take on the care of a patient you must do everything perfectly. There was no compromise on excellence. The bariatric surgery patient deserves this commitment to perfect care no less than anyone. We sought to do this for our band patients.

First, we needed to optimize the surgical technique and we needed to optimize the aftercare. LAGB is a unique procedure in surgery. While the surgery must be exactly correct, LAGB is the only procedure I can think of where the surgery itself does nothing. It just sets the scene for the aftercare. By placing the band, we have the ability to control appetite. Now, through the simple process of adjustment, we modify the satiety center of the hypothalamus. We must do that adjustment process precisely and the patient must know how to eat optimally for the band. We developed models of aftercare that included physicians, mid-level practitioners, data management systems, and comprehensive patient education materials, including books and DVDs. The book, The Lap-Band Solution (Figure 1Cover) is subtitled “A Partnership for Weight Loss.”[6] This partnership of the healthcare providers and the patients is critical as the key to generating substantial, durable weight loss gently and safely. Over 100,000 copies have been printed and dispersed so far.

The two particular contributions for which I am most pleased have been the careful collection of data on all our patients and the application of randomized, controlled trials (RCTs). From the first band patient onwards, I collected all the relevant data. With expert help from my colleague, Mark Stephens, I set up the bariatric data management program called LapBase, which remains our data manager today, facilitating the day-to-day care of our patients and providing the group data. LapBase has been the invaluable database for numerous publications of various outcomes, including the recent report of our long-term results with good follow-up.[7] Importantly, the database served to keep my spirits up during the bad times. I felt disheartened when I would happen to see several patients in a row who were not doing well, and I would feel the band just wasn’t working. I asked myself if I should give up and go back to bypass. Then I would look at the data for the whole group on LapBase and realize the majority of patients were doing fine, the results were improving, and I would push on. The data tell you the truth. Without the data, you will never know.

My mentor in RCTs was Jim McK. Watts, an excellent academic surgeon and one of the founders of the Obesity Surgery Society of Australia and New Zealand. I was fortunate enough to work with him during the late 70s and early 80s while he was Chairman of the Department of Surgery at Flinders University in South Australia. We were doing stapling procedures and he led the Adelaide study, which was arguably the best RCT in bariatric surgery at that time, comparing gastric bypass, gastroplasty, and gastrogastrostomy in a total of 310 patients.[8]

A key gap for bariatric surgery into the 1990s was a lack of proof by RCT that surgical therapy was better than nonsurgical therapy. As bariatric surgeons we knew in our hearts it was better, yet more than 99 percent of individuals with obesity were sticking with nonsurgical options. We considered doing a RCT during the stapling era of the 80s, but we felt the gap between medical therapy and open gastric bypass was too wide to permit random allocation. It lacked the needed equipoise. The LAGB closed this gap. I was really stimulated to do this trial after an informal discussion with John Kral and Walter Pories at an American Society of Bariatric Surgery (ASBS) meeting around 1995 on this very real need. I thought at the time that we could do the RCT by using the band. It was safe, gentle, reversible, and acceptable to most patients. We could get it through an ethics committee, and we could recruit enough patients.

At that time, we were not offering the band if the body mass index (BMI) was less than 35kg/m2, so I selected BMI 30 to 35kg/m2 as the target group, not primarily to test if we should be including the mild-to-moderately obese as candidates in general, but because BMI 30–35kg/m2 represented the “grey zone”—the person unlikely to benefit from diet and drugs, but not quite obese enough for surgery.

We performed that study by randomly allocating 80 people to either best medical treatment or to surgery, and the results were published in 2006.[9] The surgical group did very well, having 87-percent excess weight loss (%EWL) at two years. The medical group didn’t do too badly with a 21% EWL at two years, a result probably better than any comparable medical therapy trial. Although the trial formally ended at two years, we have continued to follow these people and we published their 10 year outcomes in 2014.[10] The surgical group still showed a 63% EWL plus better health and quality of life at 10 years.

This model for RCT of medical versus surgical therapy was now set, and we subsequently proceeded with multiple RCTs, including the first RCTs of medical versus LAGB therapy in the following groups: individuals with obesity and type 2 diabetes mellitus (T2DM),[11] adolescents with obesity,[12] individuals with obstructive sleep apnea,[13] and individuals with overweight (BMI between 25 and 30kg/m2) and T2DM.[14] In this latter study, we use the band as a pure metabolic treatment as no obesity is present. The two-year follow-up results were impressive, and we are now completing the five-year follow up on these patients to ensure durability of effect.

These various studies are truly team events, and there were important contributions by Wendy Brown, John Dixon, John Wentworth, and many others.

RCTs are the gold standard of clinical research and wherever possible, should be a requirement for accepting new information. However not every question can be subject to RCT for numerous reasons, and we can still learn much from observational studies as long as the data are collected prospectively, comprehensively, and accurately and most patients complete the follow up.
Flowing on from the many years of research to define what works best for the band patient, I have had the good fortune to be able to share this knowledge with surgeons across the world. From the late 1990s to the present, I have been able to provide workshops and preceptorships, books and DVDs, instruments and software, and debates and presentations throughout the United States, Europe, and South America. Such activities provided me with a better understanding of the challenges, new knowledge, and perspectives, and many enduring friendships.

New bariatric surgical procedures will continue to appear and you inevitably start at the bottom of the learning curve. First, optimize the techniques then measure the effectiveness accurately. Only then should we try to estimate the place for a new procedure within our bariatric armamentarium.

References
1.    Szinicz G, Schnapka G. A new method in the surgical treatment of disease. Acta Chir Austriaca. 1982;14:43.
2.    Szinicz G, Muller L, Erhart W, Roth FX, Pointner R, Glaser K. “Reversible gastric banding” in surgical treatment of morbid obesity—results of animal experiments. Res Exp Med. 1989;189:55–60.
3.    Kuzmak LI. A review of seven years’ experience with silicone gastric banding. Obes Surg. 1991;1:403–408.
4.    Forsell P, Hallberg D, Hellers G. Gastric banding for morbid obesity: Initial experience with a new adjustable band. Obes Surg. 1993;3:369–374
5.    Himpens J, Cadiere GB, Bazi M, Vouche M, Cadiere B, Dapri G. Long-term outcomes of laparoscopic adjustable gastric banding. Arch Surg. 2011;146:802–807.
6.    O’Brien P. The Lap-Band Solution: A Partnership for Weight Loss. Melbourne, Australia: Melbourne University Publishing; 2011.
7.    O’Brien P, McDonald L, Anderson M, Brennan L, Brown WA. Long term outcomes after bariatric surgery: fifteen year follow up after gastric banding and a systematic review of the literature. Ann Surg. 2013;257:87–94.
8.    Hall JC, Watts JM, O’Brien PE, Dunstan RE, Walsh JF, Slavotinek AH, Elmslie RG. Gastric surgery for morbid obesity. The AdelaideStudy. Ann Surg. 1990;211:419–427.
9.    O’Brien PE, Dixon JB, Laurie C, et al. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006;144:625–633.
10.    O’Brien PE, Brennan L, Laurie C, Brown W. Intensive medical weight loss or laparoscopic adjustable gastric banding in the treatment of mild to moderate obesity: long-term follow-up of a prospective randomised trial. Obes Surg. 2013;23:1345-1353.
11.    Dixon JB, O’Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, Proietto J, Bailey M, Anderson M. Adjustable gastric banding and conventional therapy for type 2 diabetes: A randomized controlled trial. JAMA. 2008;299:316–323.
12.    O’Brien PE, Sawyer SM, Laurie C, et al. Laparoscopic adjustable gastric banding in severely obese adolescents: A randomized trial. JAMA. 2010;303:519–526.
13.    Dixon JB, Schachter LM, O’Brien PE, et al. Surgical vs. conventional therapy for weight loss treatment of obstructive sleep apnea: a randomized controlled trial. JAMA. 2012;308:1142–1149.
14.    Wentworth JM, Playfair J, Laurie C, et al. Multidisciplinary diabetes care with and without bariatric surgery in overweight people: A randomised controlled trial. Lancet Diabetes Endocrinol. 2014;2(7):545–552.

Funding: No funding was provided.

Financial Disclosures: Dr. O’Brien reports that his center has received general research support from Allergan Inc. (Dublin, Ireland), Apollo Endosurgery, Inc.(Austin, Texas), and Applied Medical (Rancho Santa Margarita, California).

Author Affiliation: Dr. Paul O’Brien is Emeritus Professor of Surgery at Monash University in Melbourne, Australia.

 

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Category: Past Articles, The History of Bariatric Surgery

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