NCT01619488已完成不适用
Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents
Kirk Reichard2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2007年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Total Weight Loss
研究概览
简要总结
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
详细描述
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 14-19
- •BMI > 35
- •history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
- •confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.
排除标准
- •history of congenital or acquired anomalies of the GI tract.
- •history of esophageal motility disorders
- •uncontrolled psychiatric problems
- •previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
- •uncontrolled eating disorders
结局指标
主要结局
Total Weight Loss
时间窗: Up to five years post surgery.
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
次要结局
- Insulin Resistance(Baseline)
研究者
Kirk Reichard
OR SURGICAL DIRECTOR
Nemours Children's Clinic
研究点 (2)
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