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临床试验/CTRI/2024/11/077336
CTRI/2024/11/077336尚未招募不适用

A Randomized Control Trial of Clinical Outcomes in Early vs Delayed Laparoscopic Cholecystectomy in cases of Acute Calculous Cholecystitis

LADY HARDINGE MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
•Mean duration of hospitalisation in early and delayed laparoscopic cholecystectomy

研究概览

简要总结

Gall stones are present in about 10 -15% of adult population in western world and 4-6% in Indian population. Between 1-4% of these adults become symptomatic every year, majority with biliary colic, but acute calculous cholecystitis is the main complication observed in patients of symptomatic gall stone disease and represents a major proportion of cases presenting to surgery emergency. Laparoscopic cholecystectomy is gold standard for management of symptomatic gall stone disease with complication rates of only 0.2%. However, the timing of surgery remains a topic of controversy. It can either be done early (mostly done within 72 hours of onset of symptoms) or can be delayed (conservative management followed by interval laparoscopic cholecystectomy after 6 weeks). The studies so far have shown some benefits of both creating a divide in the surgical community. Early surgery is infrastructurally more demanding and may require better skilled surgeon. However, delaying surgery exposes the people to gall stone related complications viz gall stone induced pancreatitis, cholangitis, choledocholithiasis, chronic cholecystitis, mucocele, empyema of gallbladder, gall stone ileus or even risk of gall bladder cancer. With this study we aim to see the clinical outcomes of early as well as delayed laparoscopic cholecystectomy in the management of cases of acute calculus cholecystitis and to compare which method of choice among ELC vs DLC has better outcome by comparing various parameters like duration of hospitalisation, duration of surgery, intraoperative difficulty, rate of conversion to open, post operative complications viz bile leak, surgical site infection and bile duct injury.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All adult patients (above 18 years of age) with diagnosis of acute calculous cholecystitis.

排除标准

  • Patients with CBD stone along with cholelithiasis.
  • Patients with moderate to severe acute pancreatitis.
  • Patients with previous upper abdominal surgery.
  • Patients unfit for laparoscopic surgery.

结局指标

主要结局

•Mean duration of hospitalisation in early and delayed laparoscopic cholecystectomy

时间窗: Baseline at the time of surgery

•Mean duration of surgery in early and delayed laparoscopic cholecystectomy

时间窗: Baseline at the time of surgery

次要结局

  • • Proportion of patients having bile duct injury in early & delayed laparoscopic cholecystectomy(• Proportion of patients having laparoscopic to open conversion in early & delayed laparoscopic cholecystectomy)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

SHUBHRIKA SINGHAL

Lady Hardinge Medical College

研究点 (1)

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