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Completed

NCT Number: NCT03077906

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

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Files data extraction

Other

Medical Files data extraction

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pierre Wauthy

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2017
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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