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Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID04852198

Comparing One Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass with 150cm Biliopancreatic Limb for Weight Loss and Metabolic Control

Led by Flevoziekenhuis · Updated on 2024-04-23

298

Participants Needed

2

Research Sites

124 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two types of gastric bypass surgeries for patients with obesity or morbid obesity. The study compares One Anastomosis Gastric Bypass OAGB with Roux-en-Y Gastric Bypass RYGB to determine which procedure provides better weight loss and metabolic control while minimizing side effects and complications. This multicenter, open-label, randomized controlled trial aims to find the optimal surgical approach for eligible patients aged 18 to 65 with specific body mass index BMI and comorbidities. Participants will be randomly assigned to one of two groups one receiving the OAGB procedure with a 150cm biliopancreatic limb, and the other undergoing the RYGB procedure with a 150cm biliopancreatic limb and a 75cm alimentary limb. Both procedures are established gastric bypass surgeries performed to help with weight loss and metabolic improvement. The studys main focus is to measure excess BMI loss two years after surgery. During the study, participants will be monitored for their weight loss progress, metabolic health, nutritional status, remission of comorbid conditions, quality of life, and any complications or serious adverse events. Researchers will collect data over a two-year period following surgery to assess these outcomes. The trial is sponsored by Flevoziekenhuis and is designed to provide insights into the relative benefits and risks of these two surgical options for patients needing bariatric surgery.

CONDITIONS

Brief Title

Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial

Research Team

S

Stef JM Smeets, MD PhD

F

Floris Bruinsma, Student

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