NCT02882685

Comparison of Mini Gastric Bypass and Roux-en-Y Gastric Bypass

Comparison of Two Operative Techniques - Mini Gastric Bypass and Roux-en-Y Gastric Bypass in the Treatment of Severe Obesity

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study compares Roux-en-Y gastric bypass with single anastomosis gastric bypass in a randomized prospective setting. This study also adresses the issue of bile reflux after MGB.

Detailed description

Roux-en-Y gastric bypass (RYGB) and single anastomosis gastric bypass (SAGB or mini gastric bypass, MGB) have both shown excellent weight-loss and effect on comorbidities such as type 2 diabetes. In this study eligible patients are randomized for either of the operations. Effects on glucose homeostasis as well as weight-loss and the effect on comorbidities are recorded during the follow-up. Before the surgery and at 6 and 12 months, all participants will undergo body composition measurements (bioimpedance, MRI and DEXA), mixed meal tests and oral glucose tolerance tests, calorimetry and biopsies of skin, subcutaneous fat and muscle will be obtained and samples of urine, feces and saliva are collected. At these timepoints, all patients will fill out questionnaires regarding psychocological, social and physical health and wellbeing. Interim analysies will be done for the first 60 patients (30 per group) after 3 months, in which safety issues and trial setup is reviewed. If there are no problems with safety and setup, the trial can be carried out according to initial plan. At 12 months, all outcomes for all patients will be analyzed. Main outcome is weight-loss one year after the surgery. Follow-up continues at 24months, 5 years and 10 years after the surgery and follow-up data will be analyzed accordingly. Also, MGB has been feared to cause bile reflux. The first 30 MGB patients will undergo a gastroscopy and a hepatobiliary scintigraphy for bile reflux detection at 6 months.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
PROCEDURE	Roux-en-y gastric bypass
PROCEDURE	Single anastomosis gastric bypass

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-12-01
• Completion: 2026-12-01
• First posted: 2016-08-30
• Last updated: 2022-07-20

Locations

2 sites across 1 country: Finland