Gastroesophageal RefluxNCT03077906

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

An observational study of Gastroesophageal Reflux, run by Pierre Wauthy at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastroesophageal Reflux
What is being tested?: Medical Files data extraction
How many people: 400 participants
Where: 1 siteBelgium
Study dates: 1 Apr 2017to 1 Jun 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

All patients who had at least 1 year of postoperative follow-up

Who cannot join

Patients who did not have postoperative gastroœsophageal reflux
Patients who stopped their postoperative follow-up
Patients with unsufficient data collection

Trial locations and contacts

1 site in 1 country.

Belgium1 site

CHU Brugmann
Brussels, 1020

Other trials in Belgium

About this study

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.

Conditions: Gastroesophageal Reflux
Being tested: Medical Files data extraction
Keywords: Gastroœsophageal Reflux, Sleeve Gastrectomy
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medical Files data extractionOther
Medical Files data extraction

Study groups in NCT03077906
Study group	Role	What they receive
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. Receives: Other: 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. Receives: Other: Medical Files data extraction

What is being measured

The primary outcome is the main question the study is designed to answer.

date of birth
date of birth of the patient
Measured: 8 years
pre-op BMI
BMI of the patient before the surgical intervention
Measured: 8 years
post-op BMI
BMI of the patient after the surgical intervention
Measured: 8 years
existing pre-op gastroœsophageal reflux
existing gastroœsophageal reflux before the surgical intervention
Measured: 8 years
post-op gastroœsophageal reflux
gastroœsophageal reflux after the surgical intervention
Measured: 8 years
occurence of other surgical interventions
occurence of other obesity surgical interventions
Measured: 8 years
medical complications
occurence of medical complications
Measured: 8 years
number of clips used during the surgery
number of clips used during the surgery
Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20171 Jun 2017

First posted13 Mar 2017
Study start1 Apr 2017
Primary completion1 Jun 2017
Study completion1 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03077906
Sponsor's protocol ID: CHUB-Reflux
Status last verified: Nov 2017
First submitted: 8 Mar 2017
Last updated: 22 Nov 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 12837713
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.
PubMed 26686303
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.
PubMed 25593922
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.
PubMed 24238733
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.
PubMed 24500799
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.
PubMed 24666452

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All Gastroesophageal Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery
ClinicalTrials.gov ID: NCT03077906
Acronym / sponsor ID: CHUB-Reflux
Conditions: Gastroesophageal Reflux
Keywords: Gastroœsophageal Reflux, Sleeve Gastrectomy
Study type: Observational
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Pierre WauthyUniversity, hospital or other
Study start: 1 Apr 2017 (actual)
Primary completion: 1 Jun 2017 (actual)
Study completion: 1 Jun 2017 (actual)
First posted: 13 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Existing gastroœsophageal reflux	–	Other: Medical Files data extractionPatients 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.
De novo gastroœsophageal reflux	–	Other: Medical Files data extractionPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

All patients who had at least 1 year of postoperative follow-up

Key exclusion criteria (3 listed)

Patients who did not have postoperative gastroœsophageal reflux
Patients who stopped their postoperative follow-up
Patients with unsufficient data collection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medical Files data extractionMedical Files data extraction	Other	De novo gastroœsophageal reflux, Existing gastroœsophageal reflux

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
Background: PubMed 12837713Nilsson 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.
Background: PubMed 26686303Mora 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.
Background: PubMed 25593922Huseini 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.
Background: PubMed 24238733Pallati 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.
Background: PubMed 24500799DuPree 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.
Background: PubMed 24666452El-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.
Individual participant dataSharing planned: No

Related trials for Gastroesophageal Reflux

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pierre Wauthy, MD study director

CHU Brugmann

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Gastroesophageal Reflux, run by Pierre Wauthy at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

date of birth (time frame: 8 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03077906, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.