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

Laval University

Status: Not yet enrolling

Conditions: Bariatric Surgery Complication; Sleeve Gastrectomy; Gastroesophageal Reflux

Treatments: Procedure: sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05690022

EndoFlip

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Before sleeve gastrectomy

No Intervention group

Description:

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.

Sleeve gastrectomy

Experimental group

Description:

After the surgical intervention, new onset or worsening of GERD will be evaluated.

Treatment:

Procedure: sleeve gastrectomy