NCT03077906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

March 8, 2017

Last Update Submit

November 20, 2017

Conditions

Gastroesophageal Reflux

Keywords

Gastroœsophageal RefluxSleeve Gastrectomy

Outcome Measures

Primary Outcomes (8)

  • date of birth

    date of birth of the patient

    8 years

  • pre-op BMI

    BMI of the patient before the surgical intervention

    8 years

  • post-op BMI

    BMI of the patient after the surgical intervention

    8 years

  • existing pre-op gastroœsophageal reflux

    existing gastroœsophageal reflux before the surgical intervention

    8 years

  • post-op gastroœsophageal reflux

    gastroœsophageal reflux after the surgical intervention

    8 years

  • occurence of other surgical interventions

    occurence of other obesity surgical interventions

    8 years

  • medical complications

    occurence of medical complications

    8 years

  • number of clips used during the surgery

    number of clips used during the surgery

    8 years

Study Arms (2)

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.

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.

Other: Medical Files data extraction

Interventions

Medical Files data extractionOTHER

Medical Files data extraction

De novo gastroœsophageal refluxExisting gastroœsophageal reflux

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (6)

  • 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.

    PMID: 12837713BACKGROUND

  • 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.

    PMID: 26686303BACKGROUND

  • 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.

    PMID: 25593922BACKGROUND

  • 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.

    PMID: 24238733BACKGROUND

  • 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.

    PMID: 24500799BACKGROUND

  • 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.

    PMID: 24666452BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Pierre Wauthy, MD

    CHU Brugmann

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 13, 2017

Study Start

April 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 22, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)