NCT00434655已完成3 期
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective Trial
North Texas Veterans Healthcare System2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Short and long term clinical outcomes
研究概览
简要总结
- The investigators aim to determine the clinical and metabolic outcomes of two available bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI > 35 with comorbidities or BMI > 40) in VETERANS.
- The investigators hypothesize that the short and long term outcomes between laparoscopic adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.
详细描述
This is a bariatric surgery Phase 3 prospective trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI > 40)
- •Age > 18 y/o
排除标准
- •Pregnancy
- •Severe uncontrolled medical or psychiatric conditions
- •Previous bariatric surgery
- •Multiple previous abdominal surgeries
结局指标
主要结局
Short and long term clinical outcomes
时间窗: 5 years
次要结局
- Metabolic outcomes(5 years)
- Esophago-gastric physiology(2 years)
- Hormonal physiology(5 years)
- Procedure costs(5 years)
研究者
研究点 (2)
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