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Recruiting NCT02857179

Study of Bariatric Surgery

Observational Bariatric Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bariatric surgery.
Who it may be relevant to
Registry conditions: Bariatric Surgery. Basic parameters: 16 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Cohort Study Monitoring Patients Undergoing Bariatric Surgery

Overview

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.

Interventions

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

Primary outcome measures

  • Weight loss in kg [Time frame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)]
  • Weight loss in kg/m² [Time frame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)]
  • Excess Weight Loss [Time frame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)]
  • % weight loss [Time frame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)]
Secondary outcome measures (7)
  • type of surgical procedure [Time frame: at the time of surgery (Day 1)]
  • age [Time frame: before surgery (Day 0)]
  • gender [Time frame: before surgery (Day 0)]
  • Type of comorbidities [Time frame: before surgery (Day 0)]
  • surgical complications [Time frame: per and postoperative (up to 25 years or loss to follow-up)]
  • dose of insulin [Time frame: after surgery (up to 25 years or loss to follow-up)]
  • number of oral medications [Time frame: after surgery (up to 25 years or loss to follow-up)]

Eligibility criteria

Inclusion criteria

  • History of bariatric surgery procedure

Exclusion criteria

  • Patients < 16 years
  • Patients > 80 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Department of Digestive Surgery, University Hospital of Edouard Herriot, Hospices Civils d — Lyon

Publications

  • 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. PMID 33387276

Identifiers

NCT: NCT02857179 · 69HCL16_0504

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗