Status:
ACTIVE_NOT_RECRUITING
4XL Study - Obesity Surgery in Adolescence
Lead Sponsor:
Sykehuset i Vestfold HF
Collaborating Sponsors:
The Hospital of Vestfold
Conditions:
Obesity, Morbid
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
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, ...
Detailed 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 conservat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00923819
Start Date
June 1 2009
End Date
December 1 2027
Last Update
April 9 2024
Active Locations (1)
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1
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Tønsberg, Norway, 3103