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临床试验/NCT01625247
NCT01625247Unknown3 期

Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis

Yonsei University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2009年6月1日最近更新:
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适应症
干预措施

试验速览

阶段
3 期
入组人数
162
试验地点
1
主要终点
frequency of postoperative complication occurrence
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.

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 85 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Acute cholecystis
  • •Laparoscopic cholecystectomy
  • •KAROFSKY PERFORMANCE SCALE > 70
  • •No history of major operation

排除标准

  • •NYHA class > 3
  • •Open cholecystectomy
  • •No- compliance
  • •Intraoperative injuries
  • •Inadequate hemostasis

研究组 & 干预措施

1 arm

Experimental

Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.

干预措施: Surgical drainage (Procedure)

2 arm

Active Comparator

Patients under LC. Allocation to sham drain,

干预措施: Surgical drainage (Procedure)

结局指标

主要结局

frequency of postoperative complication occurrence

时间窗: whinin 1 week and 8 weeks postoperatively

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Drainage is Not Necessary Procedure After... | 临床试验