Safety and effectiveness of weight loss surgery in adolescents with extreme obesity within a structured pre- and post-surgery treatment programme – Observational study, Subproject 3

Conditions: E66
Obesity

Registration Number: DRKS00004196

Lead Sponsor: Sektion Pädiatrische Endokrinologie und Diabetologie, Klinik für Kinder- und Jugendmedizin, Universität Ulm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 66

Inclusion Criteria

BMI = 35 kg/m2 with severe comorbidity or BMI = 40 kg/m2 with relevant comorbidity
- completed longitudinal growth
- stable social surroundings
- exhaustion of conservative treatment
- participation in the project Adolescents with extreme Obesity
- adequate compliance and adherence

Exclusion Criteria

- treatable causative condition
- unstable medical, psychosocial or psychiatric comorbidity
- alcohol or drug abuse
- pregnancy
- contraindication for bariatric surgery

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI reduction after 1 year

Secondary Outcome Measures

Name	Time	Method
- BMI reduction over time (biannually for 9 years)<br>- changes in somatic, psychosocial and psychiatric comorbidity (patient questionnaire, physical examination, psychiatric evaluation, laboratory and apparative studies)(annually for 9 years)<br>- peri- und postoperative complications(annually for 9 years)<br>- vitamin deficiencies (patient questionnaire, laboratory studies)(annually for 9 years)<br>- adherence with postoperative recommendations on supplements, doctors visits and nutrition (patient questionnaire)(annually for 9 years)<br>- hunger, food tolerance, gastrointestinal symptoms, dumping (patient questionnaire)(annually for 9 years)<br>- eating behavior (EDE-Q)(annually for 9 years)<br>- exercise (IPAQ)(annually for 9 years)<br>- quality of life (SF36, IWQOL)(annually for 9 years)<br>- schooling, vocation, psychosocial situation, functional impairments (patient questionnaire)(annually for 9 years)