NCT02857179

Brief Summary

The aim of this cohort study is to collect prospectively clinical data on all the patients admitted in the investigators department for bariatric surgery or for any complication of a bariatric procedure. The investigators goal is not only to improve the follow-up but also to assess and publish the investigators results regarding weight loss and the complication rate.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
77mo left

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress74%
Nov 2007Nov 2032

Study Start

First participant enrolled

November 1, 2007

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
16.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2032

Last Updated

August 5, 2016

Status Verified

July 1, 2016

Enrollment Period

25 years

First QC Date

July 27, 2016

Last Update Submit

August 2, 2016

Conditions

Keywords

bariatric surgeryfollow-upweight losscomplicationscomorbidities evolution

Outcome Measures

Primary Outcomes (4)

  • Weight loss in kg

    Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)

  • Weight loss in kg/m²

    Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)

  • Excess Weight Loss

    Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)

  • % weight loss

    Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)

Secondary Outcomes (7)

  • type of surgical procedure

    at the time of surgery (Day 1)

  • age

    before surgery (Day 0)

  • gender

    before surgery (Day 0)

  • Type of comorbidities

    before surgery (Day 0)

  • surgical complications

    per and postoperative (up to 25 years or loss to follow-up)

  • +2 more secondary outcomes

Interventions

gastric bypass Or gastric banding Or Biliopancreatic diversion with duodenal switch Or sleeve gastrectomy Or endoscopic procedure (Endobarrier,…)

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese patients (BMI \> 30) or patients admitted for a bariatric surgery complication

You may qualify if:

  • History of bariatric surgery procedure

You may not qualify if:

  • Patients \< 16 years
  • Patients \> 80 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Digestive Surgery, University Hospital of Edouard Herriot, Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

Related Publications (1)

  • Iceta S, Tardieu S, Nazare JA, Dougkas A, Robert M, Disse E. An artificial intelligence-derived tool proposal to ease disordered eating screening in people with obesity. Eat Weight Disord. 2021 Oct;26(7):2381-2385. doi: 10.1007/s40519-020-01076-2. Epub 2021 Jan 2.

MeSH Terms

Conditions

Weight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Maud ROBERT, Pr

    Department of Digestive Surgery, University Hospital of Edouard Herriot, Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 5, 2016

Study Start

November 1, 2007

Primary Completion (Estimated)

November 1, 2032

Study Completion (Estimated)

November 1, 2032

Last Updated

August 5, 2016

Record last verified: 2016-07

Locations