A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients

Fabio Garofalo

Status: Withdrawn

Conditions: Gastroesophageal Reflux; Obesity

Treatments: Procedure: DPC; Procedure: LSG

Study type: Interventional

Funder types: Other

Identifiers

NCT04287972

ORL-CHIR-003

Details and patient eligibility

About

This is a monocentric randomized controlled prospective study. A total of 122 patients will be recruited and randomized 1: 1 in the experimental group - Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure - or in the control group - Laparoscopic Sleeve Gastrectomy.

At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GastroEsophageal Reflux Disease and hiatal hernia appearance.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-65 years
• Patient with BMI between 35 and 50 Kg/m2 for whom laparoscopic sleeve gastrectomy indication was made
• Patients with no preoperative gastroesophageal reflux disease symptoms
• Hill 2-3 or 4 (with HH <2 cm) hypogastric valve diagnosed preoperatively

Exclusion criteria

• Gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-H2 drugs
• Hiatal Hernia >2cm and/or esophagitis and/or Barrett metaplasia
• Previous bariatric and/or gastric surgery
• Normal gastroesophageal valve (Hill 1)
• Motility disorders of the esophagus (documented on manometry)
• PH-study positive for gastro-oesophageal reflux disease (DeMeester Score >14.1)
• Contraindications to gastroscopy or manometry or ph-study
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Patient not legally competent
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

LSG-DPC

Experimental group

Description:

Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure.

Treatment:

Procedure: LSG

Procedure: DPC

LSG

Active Comparator group

Description:

Laparoscopic Sleeve Gastrectomy

Treatment:

Procedure: LSG