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

May 11, 2023 updated by: Oral Ospanov, University Medical Center, Kazakhstan

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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 ]

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical diagnosis of Obesity;
  2. BMI from 30 to 50 kg / m2.

Exclusion Criteria:

  1. Insulin-dependent diabetes;
  2. BMI less than 30 kg / m2 and more than 50 kg / m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR)
Laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. A ring with shape memory put on the gastric pouch
Procedure: Laparoscopic one anastomosis gastric bypass
Laparoscopic one anastomosis gastric bypass include the creation of gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. For the creation of a gastric pouch and gastroenterostomy use a linear stapler.
Device: A shape-memory ring for adjustable gastric banding
A shape-memory ring (SMR) use for adjustable gastric banding. SMR is placed around the gastric pouch above the gastro-entero-anastomosis.
Active Comparator: laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery
Laparoscopic one anastomosis gastric bypass (MGB/OAGB) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch.
Procedure: Laparoscopic one anastomosis gastric bypass
Laparoscopic one anastomosis gastric bypass include the creation of gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. For the creation of a gastric pouch and gastroenterostomy use a linear stapler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of body mass index
Time Frame: Baseline, at 12, 24, 36 months after surgery
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.
Baseline, at 12, 24, 36 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center, Kazakhstan

Investigators

  • Principal Investigator: Oral Ospanov, Professor, Corporate Foundation "University Medical Center" (UMC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

February 14, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCKazakhstan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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