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

Primary Purpose

Morbid Obesity

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Roux-en-y gastric bypass
Single anastomosis gastric bypass
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Roux-en-Y gastric bypass, Mini-gastric bypass, Single anastomosis gastric bypass

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI>35

Exclusion Criteria:

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

Sites / Locations

  • Helsinki University Central Hospital
  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RYGB

SAGB

Arm Description

Roux-en-Y gastric bypass

Single anastomosis gastric bypass

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
Weight-loss
Weight-loss at 2years, 5years and 10 years

Full Information

First Posted
July 23, 2016
Last Updated
July 18, 2022
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02882685
Brief Title
Comparison of Mini Gastric Bypass and Roux-en-Y Gastric Bypass
Acronym
RYSA
Official Title
Comparison of Two Operative Techniques - Mini Gastric Bypass and Roux-en-Y Gastric Bypass in the Treatment of Severe Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Roux-en-Y gastric bypass, Mini-gastric bypass, Single anastomosis gastric bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RYGB
Arm Type
Active Comparator
Arm Description
Roux-en-Y gastric bypass
Arm Title
SAGB
Arm Type
Active Comparator
Arm Description
Single anastomosis gastric bypass
Intervention Type
Procedure
Intervention Name(s)
Roux-en-y gastric bypass
Other Intervention Name(s)
RYGB
Intervention Type
Procedure
Intervention Name(s)
Single anastomosis gastric bypass
Other Intervention Name(s)
SAGB, Mini-gastric bypass, MGB
Primary Outcome Measure Information:
Title
Weight-loss
Description
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
Secondary Outcome Measure Information:
Title
Glucose homeostasis
Description
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
Title
Bile reflux after Mini Gastric Bypass
Description
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
Title
Weight-loss
Description
Weight-loss at 2years, 5years and 10 years
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI>35 Exclusion Criteria: Pregnancy Previous bariatric surgery Anemia esophagitis (LA B-D) esophageal intestinal metaplasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuure T Saarinen, MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31888729
Citation
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.
Results Reference
derived
PubMed Identifier
31853864
Citation
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.
Results Reference
derived

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

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