A Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass — MEMORING  

Obesity Clinical Trial

Official title: A Randomized Clinical Trial of Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass

Status Withdrawn

Clinical Trial Summary

Background and study aims:

Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). Insufficient weight loss after bariatric surgery or weight gain after surgery is a common big problem in weight loss surgery.

The use of unregulated and uncontrolled bands and rings is not always effective according to previous studies.

This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.

Methods: Adult participants (n=100) are randomly allocated to one of two groups:

Experimental surgical bariatric procedure in the first (A) group: patients (n=50) will undergo the laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) will undergo the laparoscopic one anastomosis gastric bypass (MGB/OAGB group) without band: standard surgery.

All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index.

Clinical Trial Description

This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.

Inclusion Criteria:

• BMI from 30 to 50 kg / m2;

• Ages Eligible for Study: 18 Years to 55 Years

Outcome Measures: Change of body mass index [ Time Frame: Baseline, at 12, 24, 36 months after surgery ] ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT04762849
• Study type: Interventional
• Source: University Medical Center, Kazakhstan
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2021
• Completion date: May 1, 2024