4XL Study - Obesity Surgery in Adolescence

N/AActive Not RecruitingNCT00923819

Sykehuset i Vestfold HF120 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Obesity, Morbid

Interventions

Laparoscopic gastric bypassPROCEDURE

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.

Standard conservative treatmentBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Tønsberg, Norway

Outcomes

Primary Outcomes

BMI and weight loss

Surgical or standard conservative treatment

Time frame: Baseline, Year 1, 2, 5, 10