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

NCT ID: NCT05690022

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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.

Conditions

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Gastroesophageal Reflux Sleeve Gastrectomy Bariatric Surgery Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before/after study design
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Sleeve gastrectomy

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

Group Type EXPERIMENTAL

sleeve gastrectomy

Intervention Type PROCEDURE

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

Interventions

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sleeve gastrectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Laurent Biertho

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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François-Charles Malo

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Central Contacts

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Ringuette Vickie

Role: CONTACT

15147102044

Other Identifiers

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EndoFlip

Identifier Type: -

Identifier Source: org_study_id

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