Study on the Appropriateness of Bariatric Surgery in Adolescents

NCT01249950 | Terminated

• 2 other identifiers: 08 157 022008-A01320-55
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Morbid obesity; teenagers; co-morbidities; bariatric surgery; epidemiology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

adolescents

adolescents with morbid obesity

Other: feasibility

Interventions

feasibility OTHER

feasibility

adolescents

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

adolescents

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Feasibility Studies

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Béatrice JOURET, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2010
• First Posted: November 30, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: October 1, 2013
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

FR (1)