Research

• Introduction
• Clinical Trials
• Qualifying For The Study
• The "Smart Band" Clinical Trial
• Our Researchers

Introduction

Members of The Australian Institute of Weight Control have been researching the benefits of gastric banding in the morbidly obese for over a decade. We have studied the harmful effects of obesity, the health benefits of weight loss and the optimal care of the patient undertaking gastric band surgery. We have developed a wealth of knowledge regarding the best techniques for placement of the band and follow up care of patients after surgery.

We have now treated more than 7,000 patients during the last 10 years and have published many articles on the results of our studies into the outcomes of this surgery.

The most important information that comes from these studies to date is that:

• Gastric banding is a safe procedure.
• Gastric banding leads to between 50 to 60% of excess weight loss.
• Weight loss following gastric banding leads to resolution and improvement of most of the diseases caused by obesity.
• Weight loss following gastric banding leads to improvement in quality of life.

Our extensive database enables us to track a patient’s clinical assessment and progress. It also enables us to conduct research on how effective the procedure has been in terms of individual progress as well as being able to examine what the average weight loss is at any given point in time for all patients.

It must be stated that when patients information is used for research that it is "de-identified", which means that no identifying markers will be used and patients will only be identified by their file number and initials.

Clinical Trials

In addition to expanding our knowledge by research into patient outcomes, the Institute is also involved in a number of clinical trials. Before any drug, device or surgery makes it to market it goes through a series of stringent clinical trials.

A clinical trial is a research study conducted with patients who have been diagnosed with major illness and generally involves testing of new treatments (whether drugs or devices) or finding ways of improving existing treatments. Clinical trials are conducted all over the world in most large hospitals in an attempt to improve treatment for many diseases. The main objective of a clinical trial is to compare two or more groups of subjects, using two or more treatment options to determine the effectiveness of a proposed drug or biological treatment.

Clinical trials are carefully and ethically designed to allow truthful and precise collection and analysis of information to find out more about a disease. Such trials help discover whether a promising new treatment is safe and effective, as well as giving a better understanding of the current standard treatment, in the hope of improving the side effects experienced by many patients.

Implantable Vagal Block Therapy (VBLOC) Under Clinical Investigation as a Treatment for Obesity.

EnteroMedics Inc. is developing implantable systems to treat obesity and other gastrointestinal disorders. Its VBLOC™ Therapy is designed to precisely control, or "neuroregulate", nerve and organ function. The vagal nerves regulate much of the activity of the stomach and the pancreas and are also believed to play a significant role in the signaling of satiety and hunger.

VBLOC Therapy delivers high frequency, low energy electrical signals through laparoscopically implanted leads to block vagal nerve transmission. The delivery of energy to the nerves is intermittent and the effects of VBLOC Therapy on the nerves and end organs are intended to be reversible. The system is designed to be precisely programmed and non-invasively adjusted to meet individual needs. Unlike the majority of existing surgical obesity treatments, normal digestive system anatomy is preserved. Clinical trials are intended to show that VBLOC Therapy will help those who are morbidly obese manage their weight.

Currently available surgical obesity treatments such as gastric bypass surgery and laparoscopic banding alter normal anatomy to reduce stomach size. Clinical studies will demonstrate if VBLOC Therapy offers a safe and effective alternative to the well known complications associated with existing approaches to bariatric surgery.

VBLOC Therapy is undergoing clinical investigation for obesity treatment at select centers within and outside the United States. The Australian Institute of Weight Control’s clinics in Adelaide and Sydney have been selected as the only clinical trial sites outside the U.S.A.

If you are willing to make a commitment to losing weight and participating in a medical weight management program that will provide education and advice on diet, exercise and behavioral modification—and you meet the eligibility requirements of the clinical investigation—VBLOC™ Therapy might be for you.

Qualifying for the study

In order to be eligible to participate in the EMPOWER clinical research study and receive investigational VBLOC Therapy, all patients must meet the inclusion criteria. These criteria are carefully thought out to include those patients who are the best possible candidates for the clinical research study. These criteria include:

• Be a male or female between the age of 18 and 65
• Have a BMI (Body Mass Index) between 35 and 45*
• Sign an informed consent

This is just a partial list of criteria for acceptance into the clinical research study. Only a clinical research study staff member can make that determination.

For more information about VBLOC Therapy and the EMPOWER clinical research study, please call Jane Collins at Circle of Care Adelaide on (08) 8404 2359 Ruth Hutchinson at Circle of Care Sydney on (02) 1300 722224.

The "Smart Band" Clinical Trial

Effective weight loss after gastric banding is dependent appropriate band adjustments to determine and maintain optimal individualized restriction. Traditionally, band adjustments are performed by injecting sterile saline into the port. The amount of saline added is determined empirically and is based on achieving a level of fullness or satiety after small portions of food, without causing regurgitation or vomiting. Too little inflation of the gastric band can result in inadequate restriction and weight loss, whereas too much inflation may result in increased risk of regurgitation, vomiting, reflux, or oeophageal and pouch complications. Most algorithms used are volume-based and rely on stepwise filling based on patient feedback. The Australian Institute of Weight Control is currently investigating a new approach based on “in vivo band manometry”, which measures pressure within the gastric band.

Current gastric band patients are invited to participate in this clinical trial to evaluate whether it is possible to consistently measure the pressure within the gastric band. The information obtained in this study will be used to determine if it may be feasible to use pressure based gastric band adjustments in the future.

Ethicon Endo-Surgery, Inc. is the company funding this study (International Sponsor) and is located in the United States. The Local Sponsor is Johnson and Johnson Medical Pty Ltd located in North Ryde NSW.

Without research there is no development. The Australian Institute of Weight Control has committed significant resources to undertake research projects at all of our locations. We participate in global weight loss studies, conduct research on new devices and closely monitor international trends on new research.

This allows us to continually review our processes and ensure our services meet the highest standards both in Australia and globally.

Our Researchers

Professor James Toouli MBBS, FRACS

Our team of research fellows and research assistants are directed by Professor Jim Toouli who is recognized world wide for his surgical expertise and extensive research activities. He is Professor of Surgery at Flinders University in Adelaide and Co-Director of Circle of Care Adelaide. Jim is a member of the original team who began performing bariatric surgery at Flinders in the 1980s. . He has been responsible for training surgeons in bariatric and abdominal surgery nationally and internationally. His research in digestive diseases as well as obesity has attracted funding support from NH & MRC, other Government and semi-government organizations as well as the biomedical industry. He has authored over 200 publications in peer reviewed journals, over 50 invited chapters and edited 6 surgical books. Currently he supervises a number of clinical and laboratory based research projects in collaboration with a number of scientists and supervises a number of PhD and other higher degree students.

Dr Anthony Brancatisano B Appl Sc, MB BS, Ph D

Tony is Director of Research and Education at the Sydney Circle of Care. He is a medical practitioner and assistant surgeon in laparoscopic surgery. He achieved his research qualifications from Sydney University in 1987 as a National Health and Medical Research Council of Australia Research Scholar and undertook his post doctorate studies abroad at the Mayo Clinic in Rochester, Minnesota USA. He has written and published many peer-reviewed journal articles and book chapters. Given his broad background in research and medicine he is committed to achieving best outcomes in improving and resolving many of the co morbid illnesses associated with obesity and patient's overall quality of life.

Original Articles

Anwar, Mohamed MS; Collins, Jane; Kow, Lilian PhD, FRACS; Toouli, James PhD, FRACS Long-term Efficacy of a Low-pressure Adjustable Gastric Band in the Treatment of Morbid Obesity. Annals of Surgery. 247(5):771-778, May 2008.

Brancatisano A, Wahlroos S, Matthews S, Brancatisano R. Gastric banding for the treatment of type 2 diabetes mellitus in the morbidly obese. Surgery Obesity Related Diseases 2008, In Press.

Brancatisano A, Wahlroos S, Brancatisano R. Improvement in co morbid illness following placement of the Swedish Adjustable Gastric Band. Surgery Obesity Related Diseases. 2008, In Press.

Taylor CJ, Layani L. Laparoscopic adjustable gastric banding in patients > or =60 years old: is it worthwhile? Obes Surg. 2006 Dec;16(12):1579-83.

Al-Jiffry BO, Shaffer EA, Saccone GT, Downey P, Kow L, Toouli J. Changes in gallbladder motility and gallstone formation following laparoscopic gastric banding for morbid obestity. Can J Gastroenterol. 2003 Mar;17(3):169-74.

Greenslade J, Kow L, Toouli J. Surgical management of obesity using a soft adjustable gastric band. ANZ J Surg. 2004 Apr, 74(94):195-9.

Madeleine L Phillips1, Mark C Lewis2, Veronica Chew3, Lilian Kow4, John P Slavotinek5, Lynne Daniels6, Robin Valentine7, Jim Toouli8 and Campbell H Thompson9 The Early Effects of Weight Loss Surgery on Regional Adiposity. Obesity Surgery. Volume 15, Number 10 / November, 2005

Mark C Lewis, Madeleine L Phillips, John P Slavotinek, Lilian Kow, Campbell H Thompson and Jim Toouli Change in Liver Size and Fat Content after Treatment with Optifast® Very Low Calorie Diet Obesity Surgery, Volume 16, Number 6 / June, 2006

Abstracts:

Brancatisano A, Moulos M, Theodorou T, Turton A, Young G, Christian J, and Brancatisano R Weight Control Surgery using the Swedish Adjustable Gastric Band (SAGB): the Sydney experience. Obesity Surgery, A215, volume 15, 986, 2005.

Brancatisano R, Moulos M, Theodorou T, Turton A, Young G, Christian J, and Brancatisano A Concurrent laparascopic gastric banding and hiatus hernia repair in morbidly obese patients. Obesity Surgery, A215, volume 15, 985, 2005.

Brancatisano R Moulos M, Theodorou T, Turton A, Young G, Christian J, and Brancatisano A Multi disciplinary follow up improves results following adjustable gastric band surgery for the morbidly obese. 20th Annual Scientific Meeting of the Obesity Surgery Society of Australia and New Zealand. 2005.

Brancatisano R, Wahlroos, S, Brancatisano A. Laparoscopic Gastric Banding in the Morbidly Obese: Single Surgeon Experience of 520 patients. Obesity Surgery, A69, 1009, 2006.

Brancatisano A, Wahlroos, R Brancatisano. Improvements in Quality of Life in Morbidly Obese Patients Following Gastric Banding in a Multidisciplinary Institution. Obesity Surgery A93, 1014, 2006.

Brancatisano A, Wahlroos, R Brancatisano. Health Outcomes in Obese Patients after Weight Loss Surgery using the Swedish Adjustable Gastric Band. Obesity Surgery, A146, 1027, 2006.

Brancatisano A, Wahlroos S, Brancatisano R. Gastric Banding for the Treatment of Type 2 Diabetes Mellitus in the Morbidly Obese. Australian Diabetes Society Scientific Meeting, 23rd-25th August, A300, 124, 2006.

Phillips M, Lewis M, Wahlroos S, Slavotinek J, Valentine R, Thompson C, Toouli J. Effects of Optifast very low calorie diet on liver size and regional adiposity. Gastroenterology Suppl 2006; A-294

Brancatisano, A, Wahlroos S, Brancatisano R. Gastric banding for the treatment of type 2 diabetes mellitus in the morbidly obese.Surgery Obesity Related Diseases. 3 (3), 290-291, 2007.

Brancatisano, A, Wahlroos S, Brancatisano R. Weight loss outcomes using the Swedish adjustable gastric band in the morbidly obese: Single surgeon experience in 774 patients. Surgery Obesity Related Diseases, 3 (3), 317, 2007.

Brancatisano, A, Wahlroos, S, Brancatisano R. Quality of life before and after gastric banding in a multidisciplinary institution. Surgery for Obesity and Related Diseases. 3 (3), 321, 2007.

Other publications:

UPDATE – Medical Observer Article – Laparoscopic Gastric Banding for Morbidly Obese by Dr Roy Brancatisano, 2006.

Brancatisano A and Brancatisano R. Weight Management in Review: Bariatric surgery for weight loss – Part 1, Issue 7, InoVa Pharmaceuticals, 2008.