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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077906
• Other study ID #: CHUB-Reflux
• Status: Completed
• Phase: N/A
• First received: March 8, 2017
• Last updated: November 20, 2017
• Start date: April 1, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: November 2017
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Other:
• Medical Files data extraction
Medical Files data extraction

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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