Clinical trial NCT03077906: Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery
Official title: Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Keywords: Gastroœsophageal Reflux
Sleeve Gastrectomy
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: date of birth
timeFrame: 8 years
measure: pre-op BMI
timeFrame: 8 years
measure: post-op BMI
timeFrame: 8 years
measure: existing pre-op gastroœsophageal reflux
timeFrame: 8 years
measure: post-op gastroœsophageal reflux
timeFrame: 8 years
measure: occurence of other surgical interventions
timeFrame: 8 years
measure: medical complications
timeFrame: 8 years
measure: number of clips used during the surgery
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Pierre Wauthy, MD
role: STUDY_DIRECTOR
References:
citation: Nilsson M, Johnsen R, Ye W, Hveem K, Lagergren J. Obesity and estrogen as risk factors for gastroesophageal reflux symptoms. JAMA. 2003 Jul 2;290(1):66-72. doi: 10.1001/jama.290.1.66.
citation: Mora F, Cassinello N, Mora M, Bosca M, Minguez M, Ortega J. Esophageal abnormalities in morbidly obese adult patients. Surg Obes Relat Dis. 2016 Mar-Apr;12(3):622-628. doi: 10.1016/j.soard.2015.08.002. Epub 2015 Aug 7.
citation: Huseini M, Wood GC, Seiler J, Argyropoulos G, Irving BA, Gerhard GS, Benotti P, Still C, Rolston DD. Gastrointestinal symptoms in morbid obesity. Front Med (Lausanne). 2014 Dec 4;1:49. doi: 10.3389/fmed.2014.00049. eCollection 2014.
citation: Pallati PK, Shaligram A, Shostrom VK, Oleynikov D, McBride CL, Goede MR. Improvement in gastroesophageal reflux disease symptoms after various bariatric procedures: review of the Bariatric Outcomes Longitudinal Database. Surg Obes Relat Dis. 2014 May-Jun;10(3):502-7. doi: 10.1016/j.soard.2013.07.018. Epub 2013 Aug 29.
citation: DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014 Apr;149(4):328-34. doi: 10.1001/jamasurg.2013.4323.
citation: El-Hadi M, Birch DW, Gill RS, Karmali S. The effect of bariatric surgery on gastroesophageal reflux disease. Can J Surg. 2014 Apr;57(2):139-44. doi: 10.1503/cjs.030612.