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

Not Applicable

Completed

• Conditions: GERD; Obesity
• Interventions: Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty; Procedure: Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.

• Registration Number: NCT04828733
• Lead Sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Brief 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).

Detailed Description

One anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is gaining popularity as a primary surgical treatment for morbid obesity. The total fundoplication is the gold standard for treating GERD. Morbid obesity and GERD require simultaneous surgical treatment.

The aim study is to compare bariatric and antireflux results after OAGB/MGB plus suture cruroplasty (SCP) with FundoRing versus Nissen fundoplication and versus without total fundoplication.

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, 36 months after surgery where record the changing body mass index and change of GERD symptoms (GERD-HRQL).

Study Timeline

• Study Start: 2019-03-29
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-02
• Primary Completion: 2021-12-05
• Study Completion: 2024-05-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Class I- III obesity (BMI 30.0-50.0 kg/m)
• Patients with GERD A or B grade of reflux esophagitis (LA grade) after treatment PPI
• Hiatal hernia (HH) <5 cm
• ASA grading 1-2
• Age 18-60 years old.

Exclusion Criteria

• Giant hiatal hernia (HH) >5 cm
• Esophageal shortening
• Patients with C or D grade of RE (reflux esophagitis)
• Previously surgery on the stomach or esophagus
• Psychiatric illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OAGB + SCP + NF	laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty	laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty
OAGB + SCP	Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.	laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty

Primary Outcome Measures

Name	Time	Method
Change of body mass index	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.
Change of GERD symptoms (GERD-HRQL)	12, 24, 36 months after surgery	Success; ≥50% improvement in the baseline GERD-HRQL score Failure; \<50% improvement in the baseline GERD-HRQL score at 12,24, 36 months.

Trial Locations

Locations (1)

Oral Ospanov; 🇰🇿 Astana, Kazakhstan