Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery

November 20, 2017 updated by: Pierre Wauthy

Obesity surgery has become commonplace nowadays. This type of surgery is in full swing and although it is mostly beneficial for the health of the patient (reduction of cardiovascular risks, improvement of self image, reduction of osteo-articular risks, etc...) it is however associated with risks. There are several short and long term complications, excluding the ones related to the anesthesia and the post-op recovery: fistulas, abcesses, infections, dysphagia, risks of endobrachyoesophagus, etc...

The gastroœsophageal reflux remains by far the most common post-op complaint within patients. Patients can experience symptoms as far as 3 years after the surgery. Medical treatment alone can in most cases lighten the symptoms. However, in some cases, this treatment fails and another type of surgery (bypass) must be undertaken, which is psychologically traumatic for the patient.

This retrospective study will analyze a cohort of patients who underwent bariatric surgery (mainly sleeve gastrectomy), in order to identify those at risk of developping gastroœsophageal reflux and how this complication can be avoided in pre-op. The study will also identify cases of invalidating gastroœsophageal reflux that can be solved by obesity surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who benefited from a sleeve gastrectomy surgery between 2008 and the end of 2015 in the department of digestive surgery of the CHU Brugmann.

Patients who already had a disabling gastroœsophageal reflux resistant to medical treatment in pre-op and lost it in post-op, or patients who developped a gastroœsophageal reflux de novo.

Description

Inclusion Criteria:

  • All patients who had at least 1 year of postoperative follow-up

Exclusion Criteria:

  • Patients who did not have postoperative gastroœsophageal reflux
  • Patients who stopped their postoperative follow-up
  • Patients with unsufficient data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Existing gastroœsophageal reflux

Patients who benefited from a sleeve gastrectomy surgery between 2008 and the end of 2015 in the department of digestive surgery of the CHU Brugmann.

Patients who already had a disabling gastroœsophageal reflux resistant to medical treatment in pre-op, and lost it in post-op.
Other: Medical Files data extraction
Medical Files data extraction
De novo gastroœsophageal reflux

Patients who benefited from a sleeve gastrectomy surgery between 2008 and the end of 2015 in the department of digestive surgery of the CHU Brugmann.

Patients who developped gastroœsophageal reflux de novo.
Other: Medical Files data extraction
Medical Files data extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
date of birth
Time Frame: 8 years
date of birth of the patient
8 years
pre-op BMI
Time Frame: 8 years
BMI of the patient before the surgical intervention
8 years
post-op BMI
Time Frame: 8 years
BMI of the patient after the surgical intervention
8 years
existing pre-op gastroœsophageal reflux
Time Frame: 8 years
existing gastroœsophageal reflux before the surgical intervention
8 years
post-op gastroœsophageal reflux
Time Frame: 8 years
gastroœsophageal reflux after the surgical intervention
8 years
occurence of other surgical interventions
Time Frame: 8 years
occurence of other obesity surgical interventions
8 years
medical complications
Time Frame: 8 years
occurence of medical complications
8 years
number of clips used during the surgery
Time Frame: 8 years
number of clips used during the surgery
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Wauthy

Investigators

  • Study Director: Pierre Wauthy, MD, CHU Brugmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-Reflux

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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