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临床试验/NCT04979936
NCT04979936已完成不适用

Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy Followed by Delayed Laparoscopic Cholecystectomy in Patients With Grade II Acute Cholecystitis According to Tokyo Guidelines

Alexandria University2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
2
主要终点
operative difficulties as conversion, operative time, biliary injury

研究概览

简要总结

The aim of this study is to compare between early laparoscopic cholecystectomy versus percutaneous cholecystostomy followed by delayed interval laparoscopic cholecystectomy as regards the operative and postoperative complications

详细描述

A-Study setting: Department of Surgery, main university hospital, Faculty of Medicine, Alexandria University, Egypt. The study was approved by the Ethics Committee of our institution.

B-Study design: Retrospective clinical trial C-Study subjects: The target population are patients with preoperative diagnosis of grade II acute cholecystitis Those patients were subjected to surgery either early laparoscopic cholecystectomy or delayed laparoscopic cholecystectomy after percutaneous cholecystostomy

Inclusion criteria of the study patients:

-Specific written informed consent approved by our Institution's Ethics Committee was obtained from all the treated patients.

Exclusion criteria:

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

入选标准

  • patients with one of the criteria stated by grade II (moderate) Tokyo guidelines for acute cholecystitis who were managed either by early LC or by a bridging PC followed by delayed LC.

排除标准

  • grade I or III acute cholecystitis
  • common bile duct stones or jaundice,
  • Liver cirrhosis,
  • severe upper abdominal adhesions,
  • acalculous cholecystitis
  • major comorbidities in which laparoscopic surgery is contraindicated.
  • those who followed a conservative treatment for acute cholecystitis

结局指标

主要结局

operative difficulties as conversion, operative time, biliary injury

时间窗: at the time of cholecysctomy

as assessed by the main surgeon

postoperative complications

时间窗: 30 days after the operation

as assessed by clavien dindo classification

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 (2)

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