Study on the Appropriateness of Bariatric Surgery in Adolescents

Morbid Obesity Clinical Trial

Official title:

Study on the Appropriateness of Bariatric Surgery in Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01249950
• Other study ID #: 08 157 02
• Secondary ID: 2008-A01320-55
• Status: Terminated
• Phase: N/A
• First received: November 26, 2010
• Last updated: November 8, 2013
• Start date: October 2009
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Other:
• feasibility
feasibility

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	potential number of patients eligible for surgery	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	No