NCT01497028终止不适用
Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding
Jacksonville Surgical Associates2 个研究点 分布在 1 个国家开始时间: 2011年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 试验地点
- 2
- 主要终点
- Weight Loss
研究概览
简要总结
This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes
- Weight Loss
- Co-morbid disease resolution
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following criteria to be eligible for study entry:
- •Age between 18 - 80 years, and
- •Severely or Morbidly obese:
- •BMI > 35, or
- •BMI > 30 + co-morbid obesity related disease condition
- •Without any contraindications to bariatric surgery, and
- •Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)
- •Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain
排除标准
- •Subjects meeting the following criteria will be excluded from study entry:
- •Any patient not meeting the inclusion criteria
- •Patients with any major medical problems contraindicating surgery
- •Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
- •Patients who elect to undergo a surgery other than a PLAGB or SLAGB
- •Pregnant or planning pregnancy within 12 months
- •Alcohol or drug addiction
- •Established infection anywhere in the body at the time of surgery
- •Previous history of other bariatric surgery (except LAGB)
- •Family or patient history of autoimmune disease
结局指标
主要结局
Weight Loss
时间窗: 3 years
次要结局
未报告次要终点
研究者
Robert Cywes, M.D., PhD
Prinicipal Investigator
Jacksonville Surgical Associates
研究点 (2)
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