Index Laparoscopic Cholecystectomy Following Clearance of Common Bile Duct Stones Via Endoscopic Retrograde Cholangiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- recurrence of biliary events
研究概览
简要总结
The goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after ERCP. The main questions it aims to answer are: laparoscopic cholecystectomy
- Does index laparoscopic cholecystectomy associate with less recurrence of biliary complications?
- Is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ERCP to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes.
Participants will:
Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.
详细描述
The study population of this randomized controlled trial study is those who underwent CBD stone clearance by ERCP. The included fifty patients were stratified randomly into two groups: early and delayed.
Randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. Laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from CBD while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home.
Laparoscopic cholecystectomy was performed by the same surgical team for both groups.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with concomitant gallbladder and common bile duct stone who underwent clearance of common bile duct stones by ERCP
排除标准
- •patients with any of the following:
- •Severe pancreatitis
- •Suspicion of post-ERCP bleeding or perforation,
- •Associated malignancy
- •Those in whom ERCP failed to clear the CBD stones
结局指标
主要结局
recurrence of biliary events
时间窗: up to 3 months after surgery
the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy
次要结局
- operative time(during surgery)
- pancreatitis(3 months after surgery)
- conversion to open surgery(During surgery)
- Bleeding(during surger and up to 3 weeks)
- the presence of intraoperative adhesions(During surgery)
- Bile leak(up to 1 week after surgery)
- Wound infection(up to 3 months after surgery)
- hospital stays(from admission to the end of post operative follow up at 3 months after surgery)
- post oprative pain(after surgery and up to 3 days)
研究者
Wael Ahmed El-Dawy
Lecturer of Hepatopacreatobiliary and GI Surgery
Damanhour Medical National Institute