NCT01249950终止不适用
Study on the Appropriateness of Bariatric Surgery in Adolescents
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- potential number of patients eligible for surgery
研究概览
简要总结
single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.
详细描述
This is a feasibility study in order to file a subsequent national project as part of a PHRC on bariatric surgery in adolescents.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •failure of weight loss in an organized care> 6 months
- •BMI > à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI > or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life.
- •Patients must have completed their growth (bone age > 13 for girls and >15 for boys).
- •The teenager and his legal representative must have given their informed consent.
- •The subject must be affiliated to a social security scheme
排除标准
- •syndromic obesities
- •tumor-induced obesity
- •Patient with severe psychiatric disorders
- •Patient with eating disorders
- •Patients under judicial protection
- •Patient under guardianship or curatorship
- •Patient participating in another study
结局指标
主要结局
potential number of patients eligible for surgery
时间窗: 24 months
evaluate prospectively the potential number of patients eligible for surgery, among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity.
次要结局
未报告次要终点
研究者
研究点 (1)
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