Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Event ("Global Morbidity").
研究概览
简要总结
The purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
详细描述
In acute biliary cholecystitis, there was a dogma that patients should be operated within 72 hours of evolution. However, retrospective studies suggested that laparoscopic cholecystectomy even after 72 hours was safe. Moreover, some randomized controlled-trials did not found any differences in term of complications between early and delayed cholecystectomy, however none of these studies did separate patients according to the onset of symptoms. The aim of our present study was to compare the clinical outcomes of immediate versus delayed cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proven echographic cholecystitis
排除标准
- •pregnancy
- •immunosuppression
- •severe sepsis
- •perforated cholecystitis
- •peritonitis
- •cholangitis
- •acute pancreatitis
结局指标
主要结局
Number of Participants With Adverse Event ("Global Morbidity").
时间窗: 30 postoperative days
any adverse event occurring from time of diagnosis until the 30th postoperative day
次要结局
- Postoperative Complications(30 postoperative days)
- Length of Stay(30 postoperative days)
研究者
Nicolas DEMARTINES
Chairman of the Department of Surgery, Professor of Surgery
University of Lausanne Hospitals