Clinical trial NCT02882685: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Morbid Obesity
Keywords: Roux-en-Y gastric bypass
Mini-gastric bypass
Single anastomosis gastric bypass
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* BMI\>35

Exclusion Criteria:

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

Primary outcomes:
measure: Weight-loss
timeFrame: One year
Secondary outcomes:
measure: Glucose homeostasis
timeFrame: Up to 12 months
measure: Bile reflux after Mini Gastric Bypass
timeFrame: 6 months
measure: Weight-loss
timeFrame: 10 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Tuure T Saarinen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.