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

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

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.

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

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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