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NCT05690022 Clinical Trial

The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy

Gastroesophageal Reflux Clinical Trial

Official title:
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05690022
Other study ID # EndoFlip
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date January 1, 2024

Study information
Verified date January 2023
Source Laval University
Contact Ringuette Vickie
Phone 15147102044
Email vickie.ringuette@usherbrooke.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine if preoperative EndoFlip measurement can effectively predict postoperative GERD-related quality of life and lower esophageal acid exposure.

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 information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date January 1, 2024
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• sleeve gastrectomy
Patients will be recruited for a sleeve gastrectomy according to the guidelines of the National Institute of Health.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Laval University Université de Sherbrooke

Outcome
Type Measure Description Time frame Safety issue
Primary New-onset of gastroesophageal reflux disease total time of esophageal acid exposure (minutes) 12 months postoperatively
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