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

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Other: Medical Files data extraction

• Registration Number: NCT03077906
• Lead Sponsor: Pierre Wauthy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-13
• Study Start: 2017-04-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
De novo gastroœsophageal reflux	Medical Files data extraction	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.
Existing gastroœsophageal reflux	Medical Files data extraction	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium