Final Patient Enrolled in Registry of Incisionless Gastric Pouch and Stoma Reduction Procedure

LEXINGTON, Ky. — Bluegrass Bariatric Surgical Associates announced that the final patient has been enrolled in a large, multi-institution registry designed to evaluate the results of an innovative Incisionless gastric pouch and stoma reduction procedure, known as Revision Obesity Surgery, Endolumenal (ROSE). The ROSE procedure reduces the size of a gastric bypass patient's stomach pouch and stoma to approximate the original post-gastric bypass proportions to help them back onto the path of weight loss.

Gastric bypass surgery offers a very effective means to lose weight. It is not, however, always a permanent fix. Up to 44 percent of patients who undergo gastric bypass begin to regain weight — and the serious co-morbidities associated with it — a few years after their initial operation.

Bluegrass Bariatrics surgeons G. Derek Weiss, MD, FACS, FASMBS and John Oldham, Jr., MD, FASMBS, are participants in the 116-patient, nine-site registry. All the patients entered in the registry will be followed for two years.

"Traditionally, patients who regained weight after gastric bypass had few options to reverse that weight gain because their original surgery make an 'open' revision far too dangerous," said Weiss, who, along with Oldham, performed ROSE on 26 of the registry patients. "The ROSE procedure helps overcome the past safety issues of open surgery with very short recovery times and minimal side effects. Our first patient lost 25 pounds in the first month following ROSE. We look forward to following all of our patients to determine the long term results of the procedure, which we believe has the potential to dramatically impact bariatric surgery."

To perform ROSE, surgeons use a small, flexible endoscope and a new EndoSurgical Operating System(TM) (EOS) developed by USGI Medical Inc. The EOS is inserted through the mouth and into the stomach pouch. The EOS tools are then used to grasp tissue and deploy suture anchors to create multiple, circumferential tissue folds around the stoma, reducing the diameter of the stoma. If needed, additional anchors are then placed in the stomach pouch to reduce its volume capacity. No cuts are made into the patient's skin during the procedure.

All the patients who participated in the study had lost at least half of their excess weight following an initially successful Roux-en-Y gastric bypass operation, but then subsequently began to regain weight. Researchers will assess the success, duration and safety of the procedure, how much weight the patients lose and changes in their co-morbidities (such as diabetes).

Endoscopic evaluations will be performed at three months and a year after their ROSE procedure to determine the size of their pouch and stoma, as well as how well the anchored tissue folds have held and how their tissue has responded to the anchors.

"Eliminating skin incisions offers important advantages to patients including reduced risk of infection, less post-operative pain, faster recovery time, and no abdominal scars," said Santiago Horgan, MD, director of the UC San Diego Center for the Treatment of Obesity and director of UCSD's Center for the Future of Surgery, who also participated in the registry. "New flexible surgery tools allow us to utilize the best aspects of laparoscopy and endoscopy to complete new procedures such as ROSE that reduce the trauma associated with more invasive surgery. While the initial clinical evidence has been extremely exciting, standardizing collection and analysis of clinical results across multiple institutions via this registry will provide a more definitive, objective assessment of the benefits of this new surgical technique."

The results of this registry will be submitted for peer-review publication at a later date. All the participating sites received Institutional Review Board approval prior to enrolling patients.

"Obesity rates continue to rise, accelerating the need for safe, effective, more patient-friendly bariatric procedures that can help patients with abnormal weight gain post-gastric bypass get back to a healthy weight when diet and exercise have failed," said Gregory L. Schroder, MD, FACS. "The ROSE procedure addresses this patient population, which may continue to grow as more obese patients undergo primary gastric bypass. We look forward to following our patients and seeing the long term data from this registry."
 

More than 15 million people in the United States suffer from severe obesity and the numbers continue to rise. Several serious diseases and conditions are commonly associated with obesity, including Type II diabetes, hypertension, sleep apnea and cardiovascular disease. Surgical treatment of obesity has increased significantly in recent years. Over 200,000 individuals in the United States underwent bariatric surgery in 2007, and it is estimated that over 125,000 patients today are candidates waiting for an incisionless revision procedure.

Source: Bluegrass Bariatric Surgical Associates