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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
Sponsor:
Information provided by (Responsible Party):
Tuure Saarinen, Helsinki University Central Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Roux-en-y gastric bypass Procedure: Single anastomosis gastric bypass Not Applicable

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: RYGB
Roux-en-Y gastric bypass
 Procedure: Roux-en-y gastric bypass
Other Name: RYGB
Active Comparator: SAGB
Single anastomosis gastric bypass
 Procedure: Single anastomosis gastric bypass
Other Names:
  • SAGB
  • Mini-gastric bypass
  • MGB


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Weight-loss [ Time Frame: 10 years ]
    Weight-loss at 2years, 5years and 10 years


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • BMI>35

Exclusion Criteria:

  • Pregnancy
  • Previous bariatric surgery
  • Anemia
  • esophagitis (LA B-D)
  • esophageal intestinal metaplasia
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Oulu University Hospital
Oulu, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Tuure T Saarinen, MD Helsinki University Central Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Tuure Saarinen, Helsinki University Central Hospital:
Roux-en-Y gastric bypass
Mini-gastric bypass
Single anastomosis gastric bypass
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overweight
 Overnutrition
Nutrition Disorders
Body Weight