NCT00923819

4XL Study - Obesity Surgery in Adolescence

4XL-Study - Obesity Surgery in Adolescence

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sykehuset i Vestfold HF · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2009-06-18
• Last updated: 2024-04-09

Locations

1 site across 1 country: Norway