Study on the Appropriateness of Bariatric Surgery in Adolescents

November 8, 2013 updated by: University Hospital, Toulouse
single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a feasibility study in order to file a subsequent national project as part of a PHRC on bariatric surgery in adolescents.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • UHToulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adolescents

Description

Inclusion Criteria:

  • failure of weight loss in an organized care> 6 months
  • BMI > à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI > or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life.
  • Patients must have completed their growth (bone age > 13 for girls and >15 for boys).
  • The teenager and his legal representative must have given their informed consent.
  • The subject must be affiliated to a social security scheme

Exclusion Criteria:

  • syndromic obesities
  • tumor-induced obesity
  • Patient with severe psychiatric disorders
  • Patient with eating disorders
  • Patients under judicial protection
  • Patient under guardianship or curatorship
  • Patient participating in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adolescents
adolescents with morbid obesity
Other: feasibility
feasibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
potential number of patients eligible for surgery
Time Frame: 24 months
evaluate prospectively the potential number of patients eligible for surgery, among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Béatrice JOURET, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 26, 2010

First Submitted That Met QC Criteria

November 26, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08 157 02
  • 2008-A01320-55 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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