Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery
NCT ID: NCT03077906
Last Updated: 2017-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
400 participants
OBSERVATIONAL
2017-04-01
2017-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Medical Files data extraction
Medical Files data extraction
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Medical Files data extraction
Medical Files data extraction
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients who stopped their postoperative follow-up
* Patients with unsufficient data collection
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pierre Wauthy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pierre Wauthy
Head of clinic
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierre Wauthy, MD
Role: STUDY_DIRECTOR
CHU Brugmann
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Brugmann
Brussels, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUB-Reflux
Identifier Type: -
Identifier Source: org_study_id