Weight Loss Surgery in Adolescents With Extreme Obesity
- Conditions
- ObesityExtreme Obesity
- Interventions
- Procedure: bariatric surgeryOther: conservative care
- Registration Number
- NCT02062164
- Lead Sponsor
- Prof. Dr. Martin Wabitsch
- Brief Summary
The use of bariatric surgery in adolescents is controversial. On one side, bariatric surgery is the only effective treatment to achieve sustained weight loss in adults with extreme obesity. Comorbidities are reversed and mortality is reduced. In adolescents, bariatric surgery is equally effective; however, due to the paucity of long-term data, the long-term effects and risks are unknown. Thus, due to surgical risk and ethical implications, bariatric surgery is considered experimental in Germany. Nevertheless, case volumes are increasing.
The aim of this study is to evaluate the benefits and risks of adolescent bariatric surgery in the context of a structured preparation and follow-up program. The study is a subproject of the study "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care" (DRKS00004172). At 5 German university centers (Ulm, Datteln, Berlin, Essen, Leipzig), youth who undergo bariatric surgery and are participants in the overall project will be enrolled in a structured preparation and follow-up program. The program is designed to improve adherence and compliance and will result in comprehensive follow-up data. In addition to the data gathered in the overall project, subjects participating in subproject 3 will undergo assessments pertinent to bariatric surgery, as proposed in the American Teen-LABS study (http://www.cincinnatichildrens.org/ research/divisions/t/teen-labs/default/). Comparison will be made with BMI matched adolescents who participate in the overall project but do not undergo bariatric surgery.
In November 2014 recruitment for the overall project was completed. However, patients interested in bariatric surgery will still be recruited until September 2016. There assessment will be the same as for patients recruited earlier. However, in an amendment in December 2014, the frequency of assessment via questionnaire was reduced from biannually to annually. In addition, a travel reimbursement of 30€ for each study visit was implemented.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
- Arm && Interventions
Group Intervention Description bariatric surgery group bariatric surgery subjects who participate in the overall project and undergo bariatric surgery conservative care group conservative care subjects who participate in the overall project and do not undergo bariatric surgery
- Primary Outcome Measures
Name Time Method BMI change from baseline 1 year postoperative
- Secondary Outcome Measures
Name Time Method changes in somatic comorbidity every 12 months for 9 years Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.
changes in psychosocial comorbidity every 12 months for 9 years Will be assessed via standardized patient questionnaires.
changes in psychiatric comorbidity every 12 months for 9 years Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires.
vitamin deficiencies every 6 months for 9 years Will be assessed via patient questionnaire and laboratory studies.
adherence with postoperative recommendations on supplements, doctors visits and nutrition every 12 months for 9 years Will be assessed via patient questionnaire.
hunger, food tolerance, gastrointestinal symptoms, dumping every 12 months for 9 years Will be assessed via patient questionnaire.
BMI every 6 months for 9 years schooling, vocation, psychosocial situation, functional impairments every 12 months for 9 years Will be assessed via standardized patient questionnaire.
eating behavior every 12 months for 9 years Will be assessed via validated questionnaire (EDE-Q).
changes in quality of life: SF36 every 12 months for 9 years Will be assessed via validated questionnaires (SF36).
peri- und postoperative complications every 12 months for 9 years Will be assessed via physician questionnaires.
exercise every 12 months for 9 years Will be assessed via validated questionnaire (IPAQ).
changes in quality of life: IWQOL every 12 months for 9 years Will be assessed via validated questionnaires (IWQOL).
Trial Locations
- Locations (5)
Vestische Kinderklinik, University of Witten/Herdecke
🇩🇪Datteln, Germany
University Hospital Leipzig
🇩🇪Leipzig, Germany
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
🇩🇪Ulm, Germany
University Duisburg-Essen
🇩🇪Essen, Germany
Ambulatory Obesity Program, Charité University, Berlin
🇩🇪Berlin, Germany