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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04287972
• Other study ID #: ORL-CHIR-003
• Status: Withdrawn
• Phase: N/A
• Start date: November 8, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2022
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Obesity

Intervention

Procedure:
• DPC
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.
• LSG
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.

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale di Lugano, Civico e Italiano	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Fabio Garofalo

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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