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Bariatric SurgeryBARIASURGNCT02857179

Study of Bariatric Surgery

An observational study of Bariatric Surgery, run by Hospices Civils de Lyon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Bariatric Surgery
What is being tested?
bariatric surgery
Type of treatment
Surgery or procedure
How many people
5,000 participants
Where
1 siteFrance
Study dates
Nov 2007to Nov 2032
Phase
Observational
Are there results?
Not yet: the study is under way

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 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Obese patients (BMI > 30) or patients admitted for a bariatric surgery complication

Who may be able to join

  • History of bariatric surgery procedure

Who cannot join

  • Patients < 16 years
  • Patients > 80 years

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maud ROBERT, Pr contact

(0)4 72 11 62 63 ext. +33

maud.robert@chu-lyon.fr

France1 site, 1 recruiting

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

    Lyon, 69003

    Maud ROBERT, Pr, (0)4 72 11 62 63 ext. +33, maud.robert@chu-lyon.fr

    Recruiting

Other trials in France

About this study

Official title: Prospective Cohort Study Monitoring Patients Undergoing Bariatric Surgery

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.

Being tested
bariatric surgery
Keywords
bariatric surgery, follow-up, weight loss, complications, comorbidities evolution
Medical subject headings
Weight Loss

What participants receive

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

  • bariatric surgeryProcedure or surgery

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

What is being measured

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

  1. Weight loss in kg

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

  2. Weight loss in kg/m²

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

  3. Excess Weight Loss

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

  4. % weight loss

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

Secondary outcomes (7)

  1. type of surgical procedure

    gastric bypass, sleeve gastrectomy, gastric banding, biliopancreatic diversion, redo surgery, endoscopic procedure…

    Measured: at the time of surgery (Day 1)

  2. age

    demographic data: age

    Measured: before surgery (Day 0)

  3. gender

    demographic data: gender

    Measured: before surgery (Day 0)

  4. Type of comorbidities

    demographic data: comorbidities (diabetes, arterial hypertension, sleep apnea, dyslipidemia)

    Measured: before surgery (Day 0)

  5. surgical complications

    leaks, hemorrhage, phlebitis, pulmonary embolism, nutritional deficiencies, occlusions,…

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

  6. dose of insulin

    evolution of comorbidities: evolution of medical treatment

    Measured: after surgery (up to 25 years or loss to follow-up)

  7. number of oral medications

    evolution of comorbidities: evolution of medical treatment

    Measured: after surgery (up to 25 years or loss to follow-up)

Timeline

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

  1. First posted5 Aug 2016 (estimated)
  2. Study startNov 2007
  3. Primary completionNov 2032 (estimated)
  4. Study completionNov 2032 (estimated)

Resources

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
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02857179
Sponsor's protocol ID
69HCL16_0504
Acronym
BARIASURG
Status last verified
Jul 2016
First submitted
27 Jul 2016
Last updated
5 Aug 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 33387276

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery, run by Hospices Civils de Lyon at 1 site in France.

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 2 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: looking for participants now, as of the sponsor's last update on 5 Aug 2016. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Maud ROBERT, Pr ((0)4 72 11 62 63 ext. +33, maud.robert@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss in kg (time frame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)). The study lists 4 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 NCT02857179, which also lists 1 linked publication.

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 5 Aug 2016.

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