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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05690022
Enrollment
100
Registered
2023-01-19
Start date
2023-02-01
Completion date
2024-01-01
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Complication, Gastroesophageal Reflux, Sleeve Gastrectomy

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.

Interventions

PROCEDUREsleeve gastrectomy

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

Sponsors

Université de Sherbrooke
CollaboratorOTHER
Laval University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Before/after study design

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
New-onset of gastroesophageal reflux disease12 months postoperativelytotal time of esophageal acid exposure (minutes)

Contacts

Primary ContactRinguette Vickie
vickie.ringuette@usherbrooke.ca15147102044

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026