The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
Not Applicable
Not yet recruiting
- Conditions
- Sleeve GastrectomyGastroesophageal RefluxBariatric Surgery Complication
- Interventions
- Procedure: sleeve gastrectomy
- Registration Number
- NCT05690022
- Lead Sponsor
- Laval University
- Brief Summary
This study aims to determine if preoperative EndoFlip measurement can effectively predict postoperative GERD-related quality of life and lower esophageal acid exposure.
- Detailed Description
Enrolled patients will be subjected to a pre-operative gastroscopy, 48-Hour Bravo pH study and EndoFlip. In addition, each patient will complete a GERD-related quality of life questionnaire (GERD-HRQL scale). One year after surgery, patients will undergo a follow up a gastroscopy, pH study, EndoFlip and the same quality of life questionnaire to predict the incidence of postoperative GERD and determine the effect of sleeve gastrectomy.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Age between 18 and 65 years old
Exclusion Criteria
- Hiatal hernia > 2 cm at preoperative gastroscopy
- Erosive esophagitis at preoperative gastroscopy
- Barrett's metaplasia/dysplasia at preoperative gastroscopy
- Revision surgery before the end of the study
- Pregnancy during the study period
- Actively bleeding esophageal varices
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sleeve gastrectomy sleeve gastrectomy After the surgical intervention, new onset or worsening of GERD will be evaluated.
- Primary Outcome Measures
Name Time Method New-onset of gastroesophageal reflux disease 12 months postoperatively total time of esophageal acid exposure (minutes)
- Secondary Outcome Measures
Name Time Method