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Active (not recruiting) Not applicable NCT00923819

4XL Study - Obesity Surgery in Adolescence

No applicable phase (e.g. observational)
Conditions: Obesity, Morbid

Sponsor: Sykehuset i Vestfold HF

trial.available_in: БГ
Overview
The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.
Description
The study has two intervention arms: Experimental: Group A Surgery; laparoscopic gastric bypass Active comparator: Group B Patients from Child Obesity Registry of Vestfold who get standard conservative treatment in a multidisiplinary team at Morbid Obesity Center. All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Vestfold Hospital Trust The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.
Who can participate
Inclusion Criteria: * Between 13 and 18 years of age at inclusion * Tanner stage 4-5 * BMI \> 40 kg/m2 or BMI \> 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor) * At least one year multidisciplinary treatment completed Exclusion Criteria: * Tanner stage \< 4 * Substantial risk for lack of compliance * Obesity syndrome (e.g., Prader Willi syndrome) * Obesity related to brain damage * Serious general disease * Monogenic obesity
Interventions
Laparoscopic gastric bypass
PROCEDURE
Standard conservative treatment
BEHAVIORAL
Locations 1
Norway (1)
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Tønsberg
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
13 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
01.06.2009
Completion date
01.12.2035
Registry ID
NCT00923819
Source
clinicaltrials.gov
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