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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00923819
Other study ID # 4XL-2009
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 2009
Est. completion date December 2027

Study information

Verified date April 2024
Source Sykehuset i Vestfold HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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, 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date December 2027
Est. primary completion date August 2027
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic gastric bypass
Patients are referred to Morbid Obesity Center from Vestfold Hospital Trust and other hospitals in Norway. The procedure will take place at Morbid Obesity Center, Vestfold Hospital Trust.
Behavioral:
Standard conservative treatment
Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.

Locations

Country Name City State
Norway Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority Tønsberg

Sponsors (2)

Lead Sponsor Collaborator
Sykehuset i Vestfold HF The Hospital of Vestfold

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary BMI and weight loss Surgical or standard conservative treatment Baseline, Year 1, 2, 5, 10
Secondary Quality of Life (KINDL) Web-based questionnaire baseline and after 1, 2, 5 and 10 years. 10 years
Secondary Eating Disorders (Child Eating Behavior Questionnaire) Web-based questionnaire baseline and after 1, 2, 5 and 10 years. 10 years
Secondary Mental Health (Development and Well-Being Assessment, DAWBA) Web-based questionnaire baseline and after 1, 2, 5 and 10 years. 10 years
Secondary Self-Esteem (Rosenberg Self-Esteem scale) Web-based questionnaire baseline and after 1, 2, 5 and 10 years. 10 years
Secondary Surgical and Medical Complications Web-based questionnaire baseline and after 1, 2, 5 and 10 years. 10 years
Secondary Blood sample results Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years. 10 years
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