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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Obesity, GERD

Intervention / Treatment
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* Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty
* 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.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI from 30 to 50 kg / m2. Gastroesophageal reflux diseases The person is generally fit for anesthesia (ASA grading 1-2) and surgery. The person commits to the need for long-term follow-up. Exclusion Criteria: BMI less than 30 kg / m2 and more than 50 kg / m2. Prosthetic (mesh) hiatal herniorrhaphy or large hiatal hernia; Esophageal shortening Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis History of surgery on the stomach or esophagus Less than 18 or more than 60 years of age Not fit for bariatric surgery Psychiatric illness Patients unwilling or unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OAGB + SCP + FundoRing<br>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<br>* Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use FundoRing method.<br>|
| Active Comparator: OAGB + SCP + NF<br>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<br>* Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use the Nissen method.<br>|
| Active Comparator: OAGB + SCP<br>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.<br>* Laparoscopic gastric bypass with only suture cruroplasty without fundoplication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, GERD, Gastric bypass, Fundoplication, Nissen, FundoRing