- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05690022
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
January 18, 2023 updated by: Laurent Biertho, Laval University
This study aims to determine if preoperative EndoFlip measurement can effectively predict postoperative GERD-related quality of life and lower esophageal acid exposure.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ringuette Vickie
- Phone Number: 15147102044
- Email: vickie.ringuette@usherbrooke.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Before sleeve gastrectomy
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.
|
|
Experimental: Sleeve gastrectomy
After the surgical intervention, new onset or worsening of GERD will be evaluated.
|
Patients will be recruited for a sleeve gastrectomy according to the guidelines of the National Institute of Health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
New-onset of gastroesophageal reflux disease
Time Frame: 12 months postoperatively
|
total time of esophageal acid exposure (minutes)
|
12 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: François-Charles Malo, Université de Sherbrooke
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2023
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
January 1, 2024
Study Registration Dates
First Submitted
December 13, 2022
First Submitted That Met QC Criteria
January 18, 2023
First Posted (Estimate)
January 19, 2023
Study Record Updates
Last Update Posted (Estimate)
January 19, 2023
Last Update Submitted That Met QC Criteria
January 18, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EndoFlip
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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