NCT02072395已完成2 期
Treatment of Morbid Obesity With Gastric Plication and Gastric Banding
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70
- •BMI > or = to 30 and co-morbid conditions or BMI > or = to 40
- •Ability to provide informed consent
- •Willingness to commit to long-term follow-up
排除标准
- •Inability to provide informed consent
- •Presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or Prader-Willi
- •Contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion
- •Pregnancy
- •Plan to become pregnant within two years post-surgery
- •Current addiction to drugs or alcohol
- •Previous history of any type of bariatric surgery (de novo group only)
- •Hiatal hernia > 3 cm
结局指标
主要结局
Weight loss
时间窗: Two years
The primary endpoint is weight loss two years post-surgery.
Complications
时间窗: 2 years
Intra and post-operative complications will be tracked.
次要结局
未报告次要终点
研究者
Bradley Needleman
Associate Professor
Ohio State University
研究点 (2)
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