The FundoRingOAGB Versus Non-wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass

Study Overview
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Brief Summary
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Currently, one anastomosis gastric bypass (OAGB) or mini-gastric bypass (MGB) is a common bariatric procedure for treating obesity. Weight gain after surgery is a big problem in bariatric practice. Therefore, adjustable bands and rings are used, for example, FobiRing. But foreign material can cause complications - the erosion of the stomach wall. For this reason, surgeons avoid the use of various mechanical devices on living tissues. The greatest criticism is of the OAGB for the likelihood of biliary reflux. In case of reflux of bile into the esophagus after surgery, as a rule, a second operation is required with conversion OAGB to the Roux-en-Y method. In addition, along with obesity, 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 in bariatric practice, hiatus cruroraphy is performed, and less often fundoplication using the fundus of the excluded part of the stomach. We hypothesize that total fundoplication can not only treat GERD but also significant prevent the return of weight like after a banded gastric bypass and prevent postoperative bile reflux in the esophagus. The aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms. Methods: Adult participants (n=1000) are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group).

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 aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms. Methods: Adult participants (n=1000) are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and and measure secondary outcome: bile reflux in the esophagus and GERD symptoms.

Official Title
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The Total Wrapping of the Fundus of the Gastric Excluded Part (FundoRing) Versus Non- Wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass/Mini - Gastric Bypass: A Randomized Controlled Trial

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Procedure: FundoRingOAGB
* Procedure: OAGB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI from 30 to 50 kg / m2. 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: FundoRingOAGB group<br>laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part (and suture cruroplasty if present hiatal hernia). | Procedure: FundoRingOAGB<br>* laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and with suture cruroplasty if present hiatal hernia<br>|
| Active Comparator: OAGB group<br>laparoscopic one anastomosis gastric bypass (and suture cruroplasty if present hiatal hernia). | Procedure: OAGB<br>* laparoscopic one anastomosis gastric bypass with suture cruroplasty if present hiatal hernia<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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative bile reflux in esophagus | The endoscopic finding of postoperative bile reflux in the esophagus | at 12, 24, 36 months after surgery | 
| GERD symptoms | Change og GERD symptoms if present GERD or postoperative de Novo GERD symptoms (GERD-HRQL) | Baseline, 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, Bariatric surgery, One anastomosis gastric bypass, FundoRingOAGB, Fundoplication