Study on the Appropriateness of Bariatric Surgery in Adolescents

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01249950
First received: November 26, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Morbid Obesity
Other: feasibility

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study on the Appropriateness of Bariatric Surgery in Adolescents

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • potential number of patients eligible for surgery [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: October 2009
Study Completion Date: October 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
adolescents
adolescents with morbid obesity
Other: feasibility
feasibility

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adolescents

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249950

Locations
France
UHToulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Béatrice JOURET, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01249950     History of Changes
Other Study ID Numbers: 08 157 02, 2008-A01320-55
Study First Received: November 26, 2010
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Morbid obesity
teenagers
co-morbidities
bariatric surgery
epidemiology

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014