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01-12-2022 | Obesity | Study protocol

A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial

Authors: Oral Ospanov, Galymzhan Yeleuov, Alexandr Fursov, Bakhtiyar Yelembayev, Roman Fursov, Zhenis Sergazin, Adil Mustafin

Published in: Trials | Issue 1/2022

Abstract

Background

Laparoscopic one anastomosis gastric bypass (LOAGB) is a simple variation of gastric bypass and has gained worldwide popularity with clinical outcomes similar to laparoscopic Roux-en-Y gastric bypass (LRYGB) for weight loss and management of comorbidities. However, biliary reflux to the esophagus negates the benefits of LOAGB. In addition, weight gain after LOAGB and after LRYGB is a major problem in bariatric surgery.

The aim of this article is to describe the design and protocol of a randomized controlled trial comparing the outcomes of two methods of LOAGB: experimental method with wrapping versus standard method nonwrapping fundus of the excluded part of the stomach to prevent weight regain and biliary reflux after LOAGB.

Methods

The study was designed as a single-center prospective, interventional, randomized controlled trial. Masking: None (open label). Allocation: randomized. Enrollment: 100 obese patients. The relevant ethics committee approved the trial protocol.

The endpoints (body mass index, bile reflux in the esophagus, other reflux symptoms) will be assessed presurgery and postsurgery (12, 24, and 36 months postoperatively).

Discussion

With its 3-year follow-up time, this RCT will provide important data on the impact of wrapping the fundus of the excluded part of the stomach to prevent weight regain and biliary reflux after LOAGB.

Trial registration

ClinicalTrials.govNCT04834635. Registered on 8 April 2021.

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Title: A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial
Authors: Oral Ospanov
Galymzhan Yeleuov
Alexandr Fursov
Bakhtiyar Yelembayev
Roman Fursov
Zhenis Sergazin
Adil Mustafin
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Obesity
Obesity
Gastroesophageal Reflux Disease
Gastric Fundoplication
Gastric Fundoplication
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06252-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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