NCT00974194已完成不适用
Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial
University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2009年9月1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
- 268
- 试验地点
- 2
- 主要终点
- Pain (value on a Visual Analog Scale)
研究概览
简要总结
Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.
详细描述
Design:
- Prospective Randomized Controlled trial
- Population analysis based on Intention To Treat
- Patient and data analyzer blinded (double-blind trial)
Outcomes observed:
- Primary: pain
- Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption
Nbr of patients included: 260
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cholecystolithiasis
- •Age 18 to 75 y.o.
- •BMI < 35
排除标准
- •Immunodeficiency
- •Choledocholithiasis
- •Previous upperGI open surgery
结局指标
主要结局
Pain (value on a Visual Analog Scale)
时间窗: 1 year
VAS
次要结局
- Complications(1 year)
- Cosmetic results(1 year)
- Operative time(Operative day)
- Cost analysis(1 year)
研究者
Nicolas DEMARTINES
professor of surgery
University of Lausanne Hospitals
研究点 (2)
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