Morbid Obesity Requiring Bariatric Surgery Clinical Trial
Official title:
International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment