4XL Study - Obesity Surgery in Adolescence

NCT ID: NCT00923819

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2027-12-31

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, 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Laparoscopic Gastric Bypass

Group Type: EXPERIMENTAL

Laparoscopic gastric bypass

Intervention Type: PROCEDURE

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.

Group B

Standard conservative treatment. Patients from Child Obesity Registry of Vestfold.

Group Type: ACTIVE_COMPARATOR

Standard conservative treatment

Intervention Type: BEHAVIORAL

Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.

Interventions

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.

Intervention Type: PROCEDURE

Standard conservative treatment

Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital of Vestfold

OTHER

Sponsor Role: collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role: lead

Responsible Party

Samira Lekhal

PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samira Lekhal, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Vestfold Hospital Trust/The Hospital of Vestfold

Jøran Hjelmesæth, MD, PhD

Role: STUDY_CHAIR

Vestfold Hospital Trust/The Hospital of Vestfold

Locations

Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority

Tønsberg, , Norway

Countries

Norway

Other Identifiers

4XL-2009

Identifier Type: -

Identifier Source: org_study_id