One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRing vs Nissen vs OAGB Without Fundoplication

Summary

Background and study aims:

Currently, one anastomosis Gastric Bypass (OAGB) is a common bariatric procedure.

Obesity and gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. In these cases, most often for GERD patients OAGB procedures only with hiatus cruroraphy is performed.

The goal of this randomized controlled clinical trial is to compare bariatric and antireflux results after OAGB plus suture cruroplasty with FundoRing (n=50) versus Nissen fundoplication (n=50) and versus without total fundoplication (n=50) for patients with morbid obesity and GERD.

The main questions it aims to answer are:

* What is the impact of wrapping the fundus of the excluded part of the stomach use FundoRing method in the experimental group against developing reflux esophagitis compare impact standard Nissen in OAGB?
* What is the impact of excluded stomach fundoplication on weight loss in FundoRing group versus standard Nissen group in OAGB?

Methods: Adult participants (n=150) are randomly allocated to one of three groups:

Experimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty (OAGB + SCP + FundoRing); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty (OAGB + SCP +NF).

Active comparator surgical bariatric procedure in the second (C) group: patients (n=50) undergo laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty (OAGB + SCP). All patients are then followed up 12, 24, and 36 months after surgery where the changing body mass index and change of GERD symptoms (GERD-HRQL).

Conditions

• Obesity
• GERD

Interventions

PROCEDURE

laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty

Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use FundoRing method.

PROCEDURE

laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty

Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use the Nissen method.

PROCEDURE

Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.

Laparoscopic gastric bypass with only suture cruroplasty without fundoplication

Sponsors & Collaborators

• The Society of Bariatric and Metabolic Surgeons of Kazakhstan

  lead OTHER

Principal Investigators

• Oral Ospanov, Professor · President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-29

Primary Completion

2021-12-05

Completion

2024-05-10

Countries

• Kazakhstan

Study Locations