NCT05690022

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

December 13, 2022

Last Update Submit

January 18, 2023

Conditions

Gastroesophageal RefluxSleeve GastrectomyBariatric Surgery Complication

Outcome Measures

Primary Outcomes (1)

  • New-onset of gastroesophageal reflux disease

    total time of esophageal acid exposure (minutes)

    12 months postoperatively

Study Arms (2)

Before sleeve gastrectomy

NO INTERVENTION

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

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

Procedure: sleeve gastrectomy

Interventions

sleeve gastrectomyPROCEDURE

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

Sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • François-Charles Malo

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ringuette Vickie

CONTACT

15147102044vickie.ringuette@usherbrooke.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Before/after study design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 13, 2022

First Posted

January 19, 2023

Study Start

February 1, 2023

Primary Completion

July 1, 2023

Study Completion

January 1, 2024

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share