Study on the Appropriateness of Bariatric Surgery in Adolescents

Terminated

• Conditions: Morbid Obesity
• Interventions: Other: feasibility

• Registration Number: NCT01249950
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-11-26
• Study First Submitted QC: 2010-11-26
• Study First Posted: 2010-11-30
• Primary Completion: 2011-12
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adolescents	feasibility	adolescents with morbid obesity

Primary Outcome Measures

Name	Time	Method
potential number of patients eligible for surgery	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.

Trial Locations

Locations (1)

UHToulouse; 🇫🇷 Toulouse, France