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

Sponsor
Laval University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05690022
Collaborator
Université de Sherbrooke (Other)
100
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: sleeve gastrectomy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Before/after study designBefore/after study design
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

  1. New-onset of gastroesophageal reflux disease [12 months postoperatively]

    total time of esophageal acid exposure (minutes)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Laval University
  • Université de Sherbrooke

Investigators

  • Principal Investigator: François-Charles Malo, Université de Sherbrooke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laurent Biertho, Clinical Professor, Laval University
ClinicalTrials.gov Identifier:
NCT05690022
Other Study ID Numbers:
  • EndoFlip
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Gastroesophageal Reflux

Study Results

No Results Posted as of Jan 19, 2023