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

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ClinicalTrials.gov Identifier: NCT03077906
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Pierre Wauthy, Brugmann University Hospital

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.


Condition or disease Intervention/treatment
Gastroesophageal Reflux Other: Medical Files data extraction

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. date of birth [ Time Frame: 8 years ]
    date of birth of the patient

  2. pre-op BMI [ Time Frame: 8 years ]
    BMI of the patient before the surgical intervention

  3. post-op BMI [ Time Frame: 8 years ]
    BMI of the patient after the surgical intervention

  4. existing pre-op gastroœsophageal reflux [ Time Frame: 8 years ]
    existing gastroœsophageal reflux before the surgical intervention

  5. post-op gastroœsophageal reflux [ Time Frame: 8 years ]
    gastroœsophageal reflux after the surgical intervention

  6. occurence of other surgical interventions [ Time Frame: 8 years ]
    occurence of other obesity surgical interventions

  7. medical complications [ Time Frame: 8 years ]
    occurence of medical complications

  8. number of clips used during the surgery [ Time Frame: 8 years ]
    number of clips used during the surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077906


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Pierre Wauthy
Investigators
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Study Director: Pierre Wauthy, MD CHU Brugmann

Publications:
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Responsible Party: Pierre Wauthy, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03077906     History of Changes
Other Study ID Numbers: CHUB-Reflux
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierre Wauthy, Brugmann University Hospital:
Gastroœsophageal Reflux
Sleeve Gastrectomy
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases