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临床试验/NCT07130864
NCT07130864招募中不适用

Early Vs Late Laparoscopic Cholecystectomy After Ercp For Choledocholithiasis, A Randomised Control Trial.

Khyber Teaching Hospital1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年5月23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
136
试验地点
1
主要终点
Difficulty level of cholecystectomy

研究概览

简要总结

There is controversy about timing of cholecystectomy after the common bile duct is cleared of stones. our study aims to compare the results of early vs late cholecystectomy.

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
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •.All patients undergoing laparoscopic cholecystectomy who had concomitant choledocholithiasis for which ercp is done.

排除标准

  • •.Non consenting indviduals

研究组 & 干预措施

Late group

Experimental

Late group consist of those patients whose cholecystectomy is performed after 72 hours of ERCP.

干预措施: Late cholecystectomy (Procedure)

Early Group

Experimental

Early group consist of those patients whose cholecystectomy is performed within 72 hours of ERCP .

干预措施: Early cholecystectomy (Procedure)

结局指标

主要结局

Difficulty level of cholecystectomy

时间窗: From start of surgery till end, On day 1 of surgery

the presence of diffuse pericholecystic scar adhesions, Calot's triangle with intense fibrosis, atrophic gallbladder, presence of a cholecysto-enteric or cholecyto-choledochal fistula, presence of necrotic changes, liver abscess or the presence of impacted stones and the help of a senior colleague will be considered a difficult cholecystectomy

次要结局

  • Bile duct injury(From the day 1 of surgery till one month)
  • Hospital stay(from day 1 of surgery till discharge, upto 1 month)

研究者

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

Dr Saeed Sarwar

Doctor

Khyber Teaching Hospital

研究点 (1)

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