NCT01015469

Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: ClinTrio Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY). The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance. The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.

Detailed description

GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass. At least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years. Surgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.

Conditions

• Morbid Obesity Requiring Bariatric Surgery

Interventions

Type	Name	Description
PROCEDURE	Conventional laparoscopic Roux-en-Y gastric bypass	Conventional laparoscopic Roux-en-Y gastric bypass
PROCEDURE	conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring	conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-03-01
• Completion: 2015-03-01
• First posted: 2009-11-18
• Last updated: 2011-02-17

Locations

14 sites across 7 countries: Austria, Belgium, Germany, Netherlands, Poland, Portugal, Saudi Arabia