E66.05
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Morbid obesity: BMI =40 kg/m2 or BMI =35 kg/m2 with the presence of =2 comorbidities (e.g., NASH, arterial hypertension, type 2 diabetes).
Exclusion criteria
Exclusion criteria: Age at initial contact: 18 years. Celiac disease, Wilson's disease, hepatitis A, B, C, E, A1AT deficiency, autoimmune hepatitis, hemochromatosis, acute infection, psychomotoric retardation, type 1 diabetes. Reduction/maintenance of bodyweight by non-interventional therapies with a duration of =6 months before study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bodyweight in kilogram at baseline examination and at follow up examination 14 days, 28 days, 1 year, 2 years, 3 years, 4 years and 5 years after intervention. Periinterventional complications (e.g., injuries, infections, duration of procedure), postinterventional complications (e.g., injuries, duration of intensive care treatment, duration of inpatient treatment, pain diary) 14 days after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular outcome, metabolic outcome, gastrointestinal outcome, mental outcome | — |
Countries
Germany
Contacts
Kinderchirurgische Klinik und Poliklinik im Dr. von Haunerschen Kinderspital;Abteilung für Pädiatrische Gastroenterologie und Hepatologie, Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital