StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight|
- Weight loss [ Time Frame: 12 month ] [ Designated as safety issue: No ]A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.
- Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Quality of life as assessed by the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite); a ≥ 10 total score improvement from baseline (screening) will respresent a clinically significant improvement.
|Study Start Date:||July 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Post-Roux-en-Y revisional surgery using the StomaphyX device.
Revisional incisionless natural orofice surgery of gastric pouch and stoma. GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications
Other Name: Revisional NOS
Sham Comparator: Sham Procedure
Procedure: Sham procedure
Other Name: Placebo
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Anita P. Courcoulas, MD MPH FACS||University of Pittsburgh|