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StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight

2014-08-27 03:20:47 | BioPortfolio

Summary

The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine. Although RNYGB has been demonstrated as an effective bariatric procedure, a significant number of patients experience weight regain that is often associated with distended gastric anatomy. Open and laparoscopic approaches for revision are associated with higher complication rates than de novo procedures. This study will evaluate the safety and effectiveness of a revisional incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss in post-RNYGB patients who have experienced weight regain.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Obesity

Intervention

Sham procedure, Revisional incisionless natural orifice surgery of the gastric pouch and stoma using the StomaphyX device

Location

The Ohio State University Medical Center
Columbus
Ohio
United States
43210

Status

Recruiting

Source

EndoGastric Solutions

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:47-0400

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Medical and Biotech [MESH] Definitions

Surgical procedures performed through a natural opening in the body such as the mouth, nose, urethra, or anus, and along the natural body cavities with which they are continuous.

Medical procedure involving the emptying of contents in the stomach through the use of a tube inserted through the nose or mouth. It is performed to remove poisons or relieve pressure due to intestinal blockages or during surgery.

Vagal denervation of that part of the STOMACH lined with acid-secreting mucosa (GASTRIC MUCOSA) containing the GASTRIC PARIETAL CELLS. Since the procedure leaves the vagal branches to the antrum and PYLORUS intact, it circumvents gastric drainage required with truncal vagotomy techniques.

Surgical procedure in which the STOMACH is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the SMALL INTESTINE by an end-to-side SURGICAL ANASTOMOSIS, depending on the amounts of intestinal surface being bypasses. This procedure is used frequently in the treatment of MORBID OBESITY by limiting the size of functional STOMACH, food intake, and food absorption.

Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.

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