Bariatric surgery versus conservative treatment in morbidly obese children

Bariatric surgery versus conservative treatment in morbidly obese children - Bariatric surgery in children (BASIC trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47066

Enrollment

Registered

2009-07-30

Start date

2010-07-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

morbide obesitas obesity overweight

Interventions

Laparoscopic Adjustable Gastric Banding

Eligibility

Age

12 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Age 14 * 16 years (16 years inclusive) - Sex and age adjusted BMI > 40 kg/m2 or > 35 kg/m2 with co-morbidity - > 1 year organized weight reduction reducing attempts with sex and age adjusted weight loss less than 5% - Written informed consent of the patient and parents - Demonstrate decisional capacity

Exclusion criteria

Exclusion criteria: - Psychologically not suitable - Pre menarche - Bone age

Design outcomes

Primary

Measure	Time frame
Weight loss, excess weight loss, loss excess BMI	—

Secondary

Measure	Time frame
- Glucose tolerance - Fat distribution / body composition - Inflammatory status - Bloodpressure - Atherosclerosis and arterial stiffness - Microvascular function - Endothelial function - Myocardial funtion - Nonalcoholic steatohepatitis - Quality of life - Physical activity - Responsiveness to food	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)