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

Obesity Clinical Trial

— FundoRing  

Official title:

A Randomized Controlled Trial of Laparoscopic One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRingOAGB Versus NissenOAGB Versus OAGB Without Fundoplication for Treating Morbid Obesity and GERD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828733
• Other study ID #: FundoRing vs Nissen
• Status: Completed
• Phase: N/A
• Start date: March 29, 2019
• Est. completion date: May 10, 2024

Study information

• Verified date: June 2024
• Source: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 10, 2024
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• GERD
• Obesity

Intervention

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.
• 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.
• Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.
Laparoscopic gastric bypass with only suture cruroplasty without fundoplication

Locations

Country	Name	City	State
Kazakhstan	Oral Ospanov	Astana

Sponsors (1)

Lead Sponsor	Collaborator
The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body mass index	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.	Baseline, at 12, 24, 36 months after surgery
Primary	Change of GERD symptoms (GERD-HRQL)	Success; =50% improvement in the baseline GERD-HRQL score Failure; <50% improvement in the baseline GERD-HRQL score at 12,24, 36 months.	12, 24, 36 months after surgery