MGB/OAGB and LSG Effects on Lower Esophageal Sphincter (LES) Function

Study Overview
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Brief Summary
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Background While several articles have reported about the effects of laparoscopic sleeve gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is expected to be the first randomized trial exploring and comparing these two interventions. Setting Federico II University Hospital, Naples - ITALY. Methods Fifty morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and 24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or MGB/OAGB. Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss?

Official Title
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Effects of Mini/One Anastomosis Gastric Bypass (MGB/OAGB) and Sleeve Gastrectomy (LSG) on Lower Esophageal Sphincter (LES) Function. A Randomized Controlled Trial

Conditions
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Morbid Obesity, Gastroesophageal Reflux, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: MGB/OAGB
* Procedure: LSG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 80 morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 40 pts) or MGB (arm 2 - 40 pts).- Exclusion Criteria: Patients lost at follow up. Cancer patients at any stage.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Mini/One anastomosis gastric bypass<br>Execution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB) | Procedure: MGB/OAGB<br> <br> |
| Active Comparator: Laparoscopic sleeve gastrectomy<br>Execution of a laparoscopic sleeve gastrectomy (LSG) | Procedure: LSG<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modifications in terms of LES function | Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? This will be measured by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH) | 12 months | 
| Definition of the best procedure | Does one between the two procedures outperform the other one in terms of eventual LES area modifications? This will be measured in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causes of eventual modifications of LES function in relationship with a specific surgical procedure | In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss? This will be evaluated in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH) | 6 months and 12 months | 
| Causes of eventual modifications of LES function in relationship with weight loss | In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss? This will be evaluated in both procedures by the weight loss expressed as body mass index (BMI) points loss. | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mini/One anastomosis gastric bypass, Sleeve Gastrectomy, Gastro-esophageal sphincter function