Comparison of Mini Gastric Bypass and Roux-en-Y Gastric Bypass (RYSA)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Roux-en-y gastric bypass; Procedure: Single anastomosis gastric bypass

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital
  • Oulu, Finland
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI>35

Exclusion Criteria:

• Pregnancy
• Previous bariatric surgery
• Anemia
• esophagitis (LA B-D)
• esophageal intestinal metaplasia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RYGB; Roux-en-Y gastric bypass	Procedure: Roux-en-y gastric bypass; Other Names: RYGB
Active Comparator: SAGB; Single anastomosis gastric bypass	Procedure: Single anastomosis gastric bypass; Other Names: SAGB; Mini-gastric bypass; MGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	6 months
Weight-loss	Weight-loss at 2years, 5years and 10 years	10 years

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Tuure T Saarinen, MD, Helsinki University Central Hospital

Publications and helpful links

General Publications

• Saarinen T, Merilainen S, Koivukangas V, Pietilainen KH, Juuti A. Prospective randomized controlled trial comparing the efficacy and safety of Roux-en-Y gastric bypass and one-anastomosis gastric bypass (the RYSA trial): trial protocol and interim analysis. Trials. 2019 Dec 30;20(1):803. doi: 10.1186/s13063-019-3898-y.
• Saarinen T, Pietilainen KH, Loimaala A, Ihalainen T, Sammalkorpi H, Penttila A, Juuti A. Bile Reflux is a Common Finding in the Gastric Pouch After One Anastomosis Gastric Bypass. Obes Surg. 2020 Mar;30(3):875-881. doi: 10.1007/s11695-019-04353-x.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: July 23, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Roux-en-Y gastric bypass; Mini-gastric bypass; Single anastomosis gastric bypass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: HUS214/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO