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

Fabio Garofalo

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Gastroesophageal Reflux Obesity

Interventions

DPCPROCEDURE

The anterior fat pad is dissected until the left crura is visible, pars flaccida is open and the right crura exposed. Phreno-oesophageal ligament is sectioned starting from the right crura. Posterior and anterior vagal nerve are recognized before the oesophageal dissection. An intra-abdominal oesophagus lengths of 2 or 3 cm is obtained in order to reduce tension. Left and right crura are sutured with 2 or 3 non absorbable 2-0 stitches; an additional anterior stitch is posed if necessary to calibrate hiatus size without oesophageal deviation.

LSGPROCEDURE

After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ospedale Regionale di Lugano, Civico e Italiano

Lugano, Switzerland

Outcomes

Primary Outcomes

De novo GastroEsophageal Reflux Disease (GERD) onset

At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GERD (GastroEsophageal Reflux Disease)

Time frame: 6 months post surgery

Secondary Outcomes

hiatal hernia appearance

At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect hiatal hernia appearance

Time frame: 6 months post surgery

change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire

Evaluation of benefits in term of life quality by Gastroparesis Cardinal Symptom Index (GCSI) self-assessment of gastroparesis symptoms. The Gastroparesis Cardinal Symptom Index (GCSI), is a questionnaire that assess severity of symptoms associated with gastroparesis. Symptoms are rated from 0 (no symptom) to 5 (very severe)

Time frame: baseline and 6 months post surgery

change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire

Evaluation of benefits in term of life quality and reduction of Protonic Pomp Inhibitors drugs by GERD-Health Related Quality of Life questionnaire. Questionnaire (GERD-HRQL) for symptoms related to GERD. Symptoms are rated from 0 (no symptom) to 5 (Symptoms are incapacitating to do daily activities). The total Score is calculated by summing the individual scores to 15 questions. * Greatest possible score (worst symptoms) = 75 * Lowest possible score (no symptoms) = 0

Time frame: baseline and 6 months post surgery

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Evaluation of number of participants with treatment-related adverse events ( short and long term surgical complications)

Data from ClinicalTrials.gov

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