Status:
WITHDRAWN
A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients
Lead Sponsor:
Fabio Garofalo
Conditions:
Gastroesophageal Reflux
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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 Diaphragmat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04287972
Start Date
November 8 2019
End Date
October 31 2022
Last Update
April 4 2022
Active Locations (1)
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1
Ospedale Regionale di Lugano, Civico e Italiano
Lugano, Switzerland, 6900