跳至主要内容
临床试验/NCT05859607
NCT05859607招募中不适用

Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes, Sohag Experience.

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Validation and applicability of scoring systems

研究概览

简要总结

laparoscopic cholecystectomy nowadays is the most common surgery done by General surgery surgeons , so it is necessary to evaluate the difficulty of each case prior to surgery and from the first look ,to avoid complications and improve outcomes , so scoring systems are needed for better assessment of the overall condition and make good decision .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •patients with symptomatic gall stones

排除标准

  • •lap to open conversion due to equipment failure pregnancy common bile duct stone obstructive jaundice unfit for general anesthesia patients refusing lap cholecystectomy.

研究组 & 干预措施

Easy cholecystectomy

Active Comparator

easy procedure with no complications

干预措施: laparoscopic cholecystectomy (Procedure)

moderate severe cholecystectomy

Active Comparator

moderate severity with prolonged time or complication .

干预措施: laparoscopic cholecystectomy (Procedure)

difficult cholecystectomy

Active Comparator

very prolonged time , complication or conversion to open cholecystectomy .

干预措施: laparoscopic cholecystectomy (Procedure)

结局指标

主要结局

Validation and applicability of scoring systems

时间窗: 6 months

the scoring system should reach high percentage to be applicable and could be used for scoring difficulty.A comparison between preoperative score and intraoperative score, then the success of a scoring system is by the high percentage sensitivity ,preoperative data sheet will be taken from all patients ,then the first look intraoperative will judge the score through multiple items , the cross matching will be done between the two scores. and to measure the results,There are many scoring system for example Randawa preoperative and intraoperative score , Nassar preoperative and intraoperative score ,matching the result of both preoperative and intraoperative will be done to validate each one. Randawa score classified into easy and moderate and severe difficulty based on time lapsed during cholycystectomy ,intraoperative problems and complications Nassar uses the intraoperative shape of gall bladder to classify the difficulty from 1 to 5 grades upon the first look to the gall bladder.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Fahmy Mahmoud

resident doctor at General surgery department

Sohag University

研究点 (1)

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