Comparison of Mini Gastric Bypass and Roux-en-Y Gastric Bypass (RYSA)
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ClinicalTrials.gov Identifier: NCT02882685 |
Recruitment Status :
Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : July 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Morbid Obesity | Procedure: Roux-en-y gastric bypass Procedure: Single anastomosis gastric bypass | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Two Operative Techniques - Mini Gastric Bypass and Roux-en-Y Gastric Bypass in the Treatment of Severe Obesity |
Study Start Date : | July 2016 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: RYGB
Roux-en-Y gastric bypass
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Procedure: Roux-en-y gastric bypass
Other Name: RYGB |
Active Comparator: SAGB
Single anastomosis gastric bypass
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Procedure: Single anastomosis gastric bypass
Other Names:
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- Weight-loss [ Time Frame: One year ]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.
- Glucose homeostasis [ Time Frame: Up to 12 months ]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
- Bile reflux after Mini Gastric Bypass [ Time Frame: 6 months ]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.
- Weight-loss [ Time Frame: 10 years ]Weight-loss at 2years, 5years and 10 years
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI>35
Exclusion Criteria:
- Pregnancy
- Previous bariatric surgery
- Anemia
- esophagitis (LA B-D)
- esophageal intestinal metaplasia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882685
Finland | |
Helsinki University Central Hospital | |
Helsinki, Finland, 00029 | |
Oulu University Hospital | |
Oulu, Finland |
Principal Investigator: | Tuure T Saarinen, MD | Helsinki University Central Hospital |
Responsible Party: | Tuure Saarinen, MD, Helsinki University Central Hospital |
ClinicalTrials.gov Identifier: | NCT02882685 |
Other Study ID Numbers: |
HUS214/2016 |
First Posted: | August 30, 2016 Key Record Dates |
Last Update Posted: | July 20, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Roux-en-Y gastric bypass Mini-gastric bypass Single anastomosis gastric bypass |
Obesity Obesity, Morbid Overweight |
Overnutrition Nutrition Disorders Body Weight |