跳至主要内容
临床试验/CTRI/2025/11/097474
CTRI/2025/11/097474尚未招募不适用

TO STUDY OPTIMAL TIMING (EARLY VS DELAYED) OF LAPROSCOPIC CHOLECYSTECTOMY AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR CHOLEDOCHOLITHIASIS: A RANDOMISED CONTROLLED TRIAL.

Susmita Verma1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Conversion from laparoscopic cholecystectomy to open cholecystectomy in patients with Choledocholithiasis who have undergone ERCP.

研究概览

简要总结

This randomized controlled study compares early versus delayed laparoscopic cholecystectomy after ERCP in patients with choledocholithiasis. ERCP clears the common bile duct, but delaying cholecystectomy may lead to recurrent biliary attacks and increased operative difficulty due to inflammation and fibrosis around Calot’s triangle. Early surgery may reduce complications, conversion to open surgery, operative time, and hospital stay. 40 patients will be randomized into early (within 4 days) and delayed (after 6 weeks) groups, with operative outcomes and complications assessed. The study aims to determine the safer and more effective timing for surgery to ensure better clinical outcomes and patient recovery.

Patients will be randomized into early and delayed groups for laparoscopic cholecystectomy, with early surgery performed within 4 days after endoscopic retrograde cholangiopancreatography and delayed surgery performed after 6 weeks in cases of cholelithiasis and choledocholithiasis.

Choledocholithiasis mostly results from gallstones passing through the cystic duct into the common bile duct. After the resolution of acute inflammation with medical treatment such as ERCP and stone removal, cholecystectomy should be performed to prevent recurrence.

The timing of surgery plays an important role. Early (within 4 days) and late (after 6 weeks) laparoscopic cholecystectomy are compared. Early surgery reduces complications seen in delayed surgery. The study compares conversion to open surgery, operative and dissection time, intraoperative complications such as bleeding, bile duct injury, gallbladder perforation, stone or bile spillage, difficulty level according to parkland grading, and the need for readmission and interval events.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Who are willing for laparoscopic Cholecystectomy after ERCP
  • Age- 18 Years To 80 Years
  • Patients with choledocholithiasis who have undergone ERCP.

排除标准

  • Patients who arenot giving consent
  • patients with Choledocholithiasis with Failed ERCP
  • Patients undergoing open cholecystectomy
  • Post ERCP Patients who have active cholangitis.

结局指标

主要结局

Conversion from laparoscopic cholecystectomy to open cholecystectomy in patients with Choledocholithiasis who have undergone ERCP.

时间窗: Intra-operative assessment

次要结局

  • 1. OPERATIVE TIME AND DISSECTION TIME- total operative time defined as time from skin to skin closure. dissection time will be calculated from introduction of laparoscope in the peritoneal cavity till the dissection of GB from liver bed.(2. intraoperative complications comprising of bile ducts, vascular surgery, bowel injury)

研究者

发起方
Susmita Verma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Susmita Verma

Post-Graduate Institute of Medical Education and Research

研究点 (1)

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