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

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Status: Completed

Conditions: Obesity; GERD

Treatments: Procedure: Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.; Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty; Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04828733

FundoRing vs Nissen

Details and patient eligibility

About

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).

Full 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).

Enrollment: 150 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

OAGB + SCP + FundoRing

Experimental group

Description:

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

Treatment:

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

OAGB + SCP + NF

Active Comparator group

Description:

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

Treatment:

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

OAGB + SCP

Active Comparator group

Description:

laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty

Treatment:

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