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. 2022 Apr 7;23(1):264.
doi: 10.1186/s13063-022-06252-6.

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

Oral Ospanov  1 , Galymzhan Yeleuov  2 , Alexandr Fursov  2 , Bakhtiyar Yelembayev  2 , Roman Fursov  2 , Zhenis Sergazin  2 , Adil Mustafin  2
Affiliations

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

Oral Ospanov et al. Trials. .

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.gov NCT04834635 . Registered on 8 April 2021.

Keywords: FundoRingMGB; FundoRingOAGB; Fundoplication; Gastroesophageal reflux disease; Minigastric bypass; Morbid obesity; One anastomosis gastric bypass.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
FundoRing OA(M)GB - Laparoscopic anastomosis (mini) gastric bypass with total wrapping of the fundus of the gastric excluded part and suture cruroplasty.© 2021 Oral Ospanov
Fig. 2
Fig. 2
Laparoscopic one anastomosis (mini) gastric bypass was performed by Carbajo MA© 2021 Oral Ospanov
See this image and copyright information in PMC

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