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

Morbid Obesity Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02882685
Study type Interventional
Source Helsinki University Central Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date July 2016
Completion date December 2026
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