An interventional study of Roux-en-y gastric bypass and Single anastomosis gastric bypass in Morbid Obesity, sponsored by Helsinki University Central Hospital. Active, not recruiting at 2 sites in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 120 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Roux-en-Y gastric bypass
Procedure: Roux-en-y gastric bypass
Single anastomosis gastric bypass
Procedure: Single anastomosis gastric bypass
Also known as: RYGB
Also known as: SAGB, Mini-gastric bypass, MGB
Weight-loss
Main outcome is weight-loss at 1 yewar after the operationoperation. Weight-loss is calculated as excess weight-loss compared to the preoperative weight 2 months before the operation.
Time frame: One year
Glucose homeostasis
2 months before the operation glucose homeostasis status is studied (oral glucose tolerance test). Oral glucose tolerance tests will be repeated at 6months and 12 months. Continuos glucose monitoring will be done before the operation at operation and 6 months after the operation
Time frame: Up to 12 months
Bile reflux after Mini Gastric Bypass
All patients undergo a gastroscopy prior to inclusion. Patients with Barrets esophagus or LA B-C esophagitis are excluded. The first 30 patients, who are randomized to Mini Gastric Bypass will undergo a gastroscopy and a hepatobiliary scintigraphy 6 months after the operation. At hepatobiliary scintigraphy the amount of bile reflux is calculated as the amount of tracer found in the gastric pouch or esophagus in relation to total amount of tracer in the liver.
Time frame: 6 months
Weight-loss
Weight-loss at 2years, 5years and 10 years
Time frame: 10 years
Plan to share: No
This study is active, not recruiting, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital