跳至主要内容
临床试验/CTRI/2024/08/071843
CTRI/2024/08/071843尚未招募不适用

Intraoperative injection of Methylene blue into the gall bladder for delineation of Extrahepatic biliary tree during Laparoscopic Cholecystectomy

Government Stanley Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年8月15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
36
试验地点
1
主要终点
o Number of cases in which anatomical variations in cystic duct noted

研究概览

简要总结

The study will include patients admitted in surgical units at Government Stanley Medical College and Hospital scheduled for elective laparoscopic cholecystectomy with preoperative indication of symptomatic cholelithiasis and chronic cholecystitis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 20 and 65 will be included in this study.
  • Patients with diagnosis of symptomatic cholelithiasis and chronic cholecystitis confirmed by preoperative abdominal ultrasound.
  • Patients scheduled for elective laparoscopic cholecystectomy.

排除标准

  • Previous history of biliary surgery.
  • Previous history of malignancy involving the biliary tract.
  • Associated pancreatitis or hepatitis or jaundice.
  • Presence of contraindications to laparoscopic cholecystectomy.
  • Known allergy to methylene blue.
  • Not willing to provide informed consent.

结局指标

主要结局

o Number of cases in which anatomical variations in cystic duct noted

时间窗: During surgery - over 1 hour the above variables are measured. | Duration of hospital stay calculated from the time of surgery to the time of discharge

o Number of cases in which anatomical variations in common bile duct noted

时间窗: During surgery - over 1 hour the above variables are measured. | Duration of hospital stay calculated from the time of surgery to the time of discharge

o Number of cases in which injury to bile duct detected

时间窗: During surgery - over 1 hour the above variables are measured. | Duration of hospital stay calculated from the time of surgery to the time of discharge

o Number of cases in which bile leak/ spillage of dye noted

时间窗: During surgery - over 1 hour the above variables are measured. | Duration of hospital stay calculated from the time of surgery to the time of discharge

o Mean time taken for surgery

时间窗: During surgery - over 1 hour the above variables are measured. | Duration of hospital stay calculated from the time of surgery to the time of discharge

o Duration of hospital stay

时间窗: During surgery - over 1 hour the above variables are measured. | Duration of hospital stay calculated from the time of surgery to the time of discharge

次要结局

  • Number of cases in which anatomical variations in cystic duct noted(Number of cases in which anatomical variations in common bile duct noted)

研究者

发起方
Government Stanley Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Varadheswari Thiagarajan

Government Stanley Medical College and Hospital

研究点 (1)

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