A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients
- Conditions
- ObesityGastroesophageal Reflux
- Interventions
- Procedure: DPCProcedure: LSG
- Registration Number
- NCT04287972
- Lead Sponsor
- Fabio Garofalo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LSG-DPC LSG Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure. LSG LSG Laparoscopic Sleeve Gastrectomy LSG-DPC DPC Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure.
- Primary Outcome Measures
Name Time Method De novo GastroEsophageal Reflux Disease (GERD) onset 6 months post surgery 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)
- Secondary Outcome Measures
Name Time Method hiatal hernia appearance 6 months post surgery At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect hiatal hernia appearance
change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire baseline and 6 months post surgery 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)change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire baseline and 6 months post surgery 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) = 0Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 6 months post surgery Evaluation of number of participants with treatment-related adverse events ( short and long term surgical complications)
Trial Locations
- Locations (1)
Ospedale Regionale di Lugano, Civico e Italiano
🇨đź‡Lugano, Switzerland