Effectiveness and Safety of Weight Loss Surgery in Adolescents With Extreme Obesity Within a Structured Pre- and Post-surgery Treatment Program, Subproject 3
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- BMI change from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •treatable causative condition
- •unstable medical, psychosocial or psychiatric comorbidity
- •alcohol or drug abuse
- •pregnancy
- •contraindication for bariatric surgery
结局指标
主要结局
BMI change from baseline
时间窗: 1 year postoperative
次要结局
- changes in somatic comorbidity(every 12 months for 9 years)
- changes in psychosocial comorbidity(every 12 months for 9 years)
- changes in psychiatric comorbidity(every 12 months for 9 years)
- vitamin deficiencies(every 6 months for 9 years)
- adherence with postoperative recommendations on supplements, doctors visits and nutrition(every 12 months for 9 years)
- hunger, food tolerance, gastrointestinal symptoms, dumping(every 12 months for 9 years)
- BMI(every 6 months for 9 years)
- schooling, vocation, psychosocial situation, functional impairments(every 12 months for 9 years)
- eating behavior(every 12 months for 9 years)
- changes in quality of life: SF36(every 12 months for 9 years)
- peri- und postoperative complications(every 12 months for 9 years)
- exercise(every 12 months for 9 years)
- changes in quality of life: IWQOL(every 12 months for 9 years)
研究者
Prof. Dr. Martin Wabitsch
Division Chief Pediatric Endocrinology and Diabetology
University of Ulm