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

• ClinicalTrials.gov Identifier: NCT02882685
• Recruitment Status: Active, not recruiting
• First Posted: August 30, 2016
• Last Update Posted: July 20, 2022
• Sponsor: Helsinki University Central Hospital
• Information provided by (Responsible Party): Tuure Saarinen, Helsinki University Central Hospital

Tracking Information

• First Submitted Date: July 23, 2016
• First Posted Date: August 30, 2016
• Last Update Posted Date: July 20, 2022
• Study Start Date: July 2016
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 18, 2022)

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.

Original Primary Outcome Measures (submitted: August 24, 2016)

Weight-loss [ Time Frame: Up to 10 years ]

During the follow-up the weight (kg) is measured for all participants at operation, 1 month, 3 months, 6 months, 12 months, 2 years, 4 years, 7 years and ten years after the operation. Weight-loss is calculated as excess weight-loss compared to the preoperative weight 2 months before the operation.

Current Secondary Outcome Measures (submitted: July 18, 2022)

• 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

Original Secondary Outcome Measures (submitted: August 24, 2016)

• 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.
• Bile reflux after Mini Gastric Bypass [ Time Frame: 12 months ]
  All patients undergo a gastroscopy prior to inclusion. Patients with Barrets esophagus or LA B-C esophagitis are excluded. Patients, who are randomized to Mini Gastric bypass will undergo a gastroscopy and a hepatobiliary scintigraphy 12 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Mini Gastric Bypass and Roux-en-Y Gastric Bypass
• Official Title: Comparison of Two Operative Techniques - Mini Gastric Bypass and Roux-en-Y Gastric Bypass in the Treatment of Severe Obesity
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Morbid Obesity

Intervention

• Procedure: Roux-en-y gastric bypass
  Other Name: RYGB
• Procedure: Single anastomosis gastric bypass
  Other Names:

  • SAGB
  • Mini-gastric bypass
  • MGB

Study Arms

• Active Comparator: RYGB
  Roux-en-Y gastric bypass
  Intervention: Procedure: Roux-en-y gastric bypass
• Active Comparator: SAGB
  Single anastomosis gastric bypass
  Intervention: Procedure: Single anastomosis gastric bypass

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 24, 2016): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• BMI>35

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT02882685
• Other Study ID Numbers: HUS214/2016
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tuure Saarinen, Helsinki University Central Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Helsinki University Central Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Helsinki University Central Hospital
• Verification Date: July 2022