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

Not Applicable

• Conditions: Bariatric Surgery Candidate; Morbid Obesity; Gastroesophageal Reflux
• Interventions: Procedure: MGB/OAGB; Procedure: LSG

• Registration Number: NCT02987673
• Lead Sponsor: Mario Musella MD

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mini/One anastomosis gastric bypass	MGB/OAGB	Execution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB)
Laparoscopic sleeve gastrectomy	LSG	Execution of a laparoscopic sleeve gastrectomy (LSG)

Primary Outcome Measures

Name	Time	Method
Modifications in terms of LES function	12 months	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)
Definition of the best procedure	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Causes of eventual modifications of LES function in relationship with weight loss	6 months and 12 months	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.
Causes of eventual modifications of LES function in relationship with a specific surgical procedure	6 months and 12 months	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)

Trial Locations

Locations (1)

Advanced Biomedical Sciences Department - "Federico II" University; 🇮🇹 Naples, Italy