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

January 11, 2024 updated by: The Society of Bariatric and Metabolic Surgeons of Kazakhstan

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 020000
        • Oral Ospanov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OAGB + SCP + FundoRing
laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty
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.
Active Comparator: OAGB + SCP + NF
laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty
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.
Active Comparator: OAGB + SCP
laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty
Procedure: Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.
Laparoscopic gastric bypass with only suture cruroplasty without fundoplication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of body mass index
Time Frame: 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.
Baseline, at 12, 24, 36 months after surgery
Change of GERD symptoms (GERD-HRQL)
Time Frame: 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.
12, 24, 36 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2019

Primary Completion (Actual)

December 5, 2021

Study Completion (Estimated)

May 10, 2024

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FundoRing vs Nissen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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