跳至主要内容
临床试验/NCT03329859
NCT03329859已完成不适用

Impact of Microcomplications in Laparoscopic Surgery on Operative Time and Costs - Multimodal Strategy to Reduce Microcomplications

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2012年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
median hourly delay due to microcomplications

研究概览

简要总结

Objective: Investigators aimed to evaluate the impact of a high resolution standardized laparoscopic (HRSL) cholecystectomy protocol on operative time and intraoperative interruptions in a teaching hospital.

Background: Interruptions of the surgical workflow or microcomplications (MC) lead to prolonged procedure times and costs and can be indicative for surgical mistakes. Reducing MC can improve operating room efficiency and prevent intraoperative complications.

Methods: Audio video records of laparoscopic cholecystectomies were reviewed regarding type, frequency and duration of MC before and after the implementation of a HRSL which included the introduction of a stepwise protocol for the procedure and a teaching video. After consent operating team members were obliged to prepare the operation with these resources.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above and including 18 years
  • indication for laparoscopic cholecystectomy
  • written informed consent of patient
  • written informed consent of the operating team

排除标准

  • age below 18 years
  • other laparoscopic or open surgical procedure in the same operation.

研究组 & 干预措施

Interventional arm

Experimental

"High resolution standardized laparoscopic cholecystectomy" Patients in which laparoscopic cholecystectomy was performed after high Resolution standardization and Training of the OR Team according to the Standard.

干预措施: High resolution standardized laparoscopic cholecystectomy (Procedure)

Control arm

Active Comparator

No 'High resolution standardized laparoscopic cholecystectomy' Patients in which laparoscopic cholecystectomy was performed in the conventional way without prior standardization

干预措施: High resolution standardized laparoscopic cholecystectomy (Procedure)

结局指标

主要结局

median hourly delay due to microcomplications

时间窗: Any microcomplications are recorded between skin incision to skin closure during laparoscopic cholecysectomy

median hourly increase in operative time in seconds due to microcomplications before and after an intervention to reduce microcomplications. Microcomplications are defined as any interruption of the surgical workflow.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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