Back to resultsThe Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
Primary Purpose
Gastroesophageal Reflux, Sleeve Gastrectomy, Bariatric Surgery Complication
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sleeve gastrectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Before sleeve gastrectomy
Sleeve gastrectomy
Arm Description
Gastroesophageal Reflux Disease (GERD) will be evaluated before surgery. EndoFlip, gastroscopy, pH-study and GERD-Health-Related Quality of Life Questionnaire will be realized for all patients.
After the surgical intervention, new onset or worsening of GERD will be evaluated.
Outcomes
Primary Outcome Measures
New-onset of gastroesophageal reflux disease
total time of esophageal acid exposure (minutes)
Secondary Outcome Measures
Full Information
NCT ID
NCT05690022
First Posted
December 13, 2022
Last Updated
January 18, 2023
Sponsor
Laval University
Collaborators
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT05690022
Brief Title
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
Official Title
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Sleeve Gastrectomy, Bariatric Surgery Complication
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before/after study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Before sleeve gastrectomy
Arm Type
No Intervention
Arm Description
Gastroesophageal Reflux Disease (GERD) will be evaluated before surgery. EndoFlip, gastroscopy, pH-study and GERD-Health-Related Quality of Life Questionnaire will be realized for all patients.
Arm Title
Sleeve gastrectomy
Arm Type
Experimental
Arm Description
After the surgical intervention, new onset or worsening of GERD will be evaluated.
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Intervention Description
Patients will be recruited for a sleeve gastrectomy according to the guidelines of the National Institute of Health.
Primary Outcome Measure Information:
Title
New-onset of gastroesophageal reflux disease
Description
total time of esophageal acid exposure (minutes)
Time Frame
12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ringuette Vickie
Phone
15147102044
Email
vickie.ringuette@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François-Charles Malo
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
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