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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Monocentric Randomized Controlled Prospective Study to Evaluate the Antireflux Efficacy of Primary Crural Closure During Sleeve Gastrectomy for Obese Patients With Incompetents Oeso-gastric Valves

Conditions
-----------------
Gastroesophageal Reflux, Obesity

Intervention / Treatment
-----------------
* Procedure: DPC
* Procedure: LSG


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LSG-DPC<br>Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure. | Procedure: DPC<br>* 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.<br>Procedure: LSG<br>* 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.<br>|
| Active Comparator: LSG<br>Laparoscopic Sleeve Gastrectomy | Procedure: LSG<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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) | 6 months post surgery |