NCT00910325终止1 期
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- The safety and efficacy of the procedure
研究概览
简要总结
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.
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
- 26 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females who are postmenopausal or who no longer wish to bear children
- •Females >25 years old and <65 years old
- •Diagnosis of biliary disease requiring cholecystectomy
- •American Society of Anesthesiology (ASA) Class I or II
- •Females who are able to understand and willing to sign an informed consent document
排除标准
- •Pregnancy
- •BMI >= 30
- •Patients who are still interested in childbearing
- •Patients taking immunosuppressive medications or who are immunocompromised
- •Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
- •Patients with suspicion of gallbladder cancer
- •Patients with history of previous open abdominal surgery
- •Patients with untreated common bile duct stones
结局指标
主要结局
The safety and efficacy of the procedure
时间窗: one year
次要结局
- Post-operative pain(one year)
- Time to return to work(one year)
- Time to return to daily activities(one year)
研究者
David W. Rattner, MD
Chief, Division of General and Gastrointestinal Surgery
Massachusetts General Hospital
研究点 (2)
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