StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
|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 represent 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.
Transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.
Other Name: transoral incisionless fastening device
Sham Comparator: Sham Procedure
Procedure: Sham procedure
Other Name: Placebo
The Roux-en-Y gastric bypass (RNYGB) is the most commonly performed bariatric procedure to treat morbid obesity 1. Numerous studies have documented the effectiveness of RNYGB in promoting excess weight loss (EWL) typically in the 65-80% range after 1.5 to 2 years 1. Despite the favorable short-term outcomes of this bariatric surgical procedure, approximately 10-40% of patients do not achieve successful long-term weight loss 2. The weight regain occurs typically within 2 to 7 years after RNYGB surgery and is associated primarily with dilation of the gastric pouch or stoma 3, 4. Several open and laparoscopic bariatric revision procedures have been used in an attempt to correct these dilations, but they all have been associated with serious complications such as perforations, obstruction, staple line disruption, blind loop syndrome, stoma ulcer, and incisional hernias 2, 5, 6. Because of this high rate of morbidity associated with revisional gastric bypass surgery, less invasive endoscopic procedures may become a preferred approach for weight regain after RNYGB 7, 8.
The StomaphyX delivery system with SerosaFuse fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device. The device uses vacuum to invaginate tissue through a port into a chamber and fasten it using the H shaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue. Durability of the SerosaFuse fasteners has been demonstrated during several clinical studies utilizing the EsophyX device 9-12.
Reason for Conducting the Present Study: The goal of this study was to investigate the safety and effectiveness of the StomaphyX device for revisional natural orifice surgery of the gastric pouch and gastrojejunostomy anastomosis (stoma) in RNYGB patients to reduce regained weight.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939055
|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|