NCT01873638已完成不适用
Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure
Kuopio University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年2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
- 60
- 试验地点
- 2
- 主要终点
- Chronic post-surgical pain
研究概览
简要总结
Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.
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
- 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
- •Cholelithiasis confirmed by preoperative ulrasound
- •No significant co-morbidities
- •The ASA physical status classification 1 or 2
- •Age 18 to 65 yrs.
- •BMI less than 35
- •Less than a one hour journey from hospital to home
- •Patient´s own motivation to daysurgery
排除标准
- •Elevated liver laboratory tests
- •Earlier jaundice
- •A suspicion or verified stones in the common bile duct
- •Acute cholecystitis
- •A history of pancreatitis
- •Hepatic cirrhosis
- •Suspicion of cancer
- •Previous open upper abdominal surgery
- •Peptic ulcer
- •Bleeding disorders
结局指标
主要结局
Chronic post-surgical pain
时间窗: Five year outcome
次要结局
- Quality of life(Five year outcome)
研究者
Matti Eskelinen
professor
Kuopio University Hospital
研究点 (2)
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