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Study on the Appropriateness of Bariatric Surgery in Adolescents

T

Toulouse University Hospital

Status

Terminated

Conditions

Morbid Obesity

Treatments

Other: feasibility

Study type

Observational

Funder types

Other

Identifiers

NCT01249950
2008-A01320-55 (Other Identifier)
08 157 02

Details and patient eligibility

About

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.

Full description

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

Enrollment

10 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

adolescents
Description:
adolescents with morbid obesity
Treatment:
Other: feasibility

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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