Impact of Indocyanine Green Fluorescence on Surgical Precision in Difficult Cholecystectomy - A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Operative time from insertion of ports to achieving critical view of safety (CVS).
研究概览
简要总结
Surgical anatomy is difficult to visualised frequently in difficult cholecystectomies , therefore number of patients with CBD injury is higher than regular cholecystectomies hence there is a need to support the process of identification of anatomy to visualise the critical view of safety. Additionally intraoperative fluorescence imaging with ICG was recently shown to be an alternative to intraoperative cholangiography for visualizing the extrahepatic biliary structures during laparoscopic cholecystectomy ( LC).Surgical anatomy is difficult to visualised frequently in difficult cholecystectomies , therefore number of patients with CBD injury is higher than regular cholecystectomies hence there is a need to support the process of identification of anatomy to visualise the critical view of safety. Additionally intraoperative fluorescence imaging with ICG was recently shown to be an alternative to intraoperative cholangiography for visualizing the extrahepatic biliary structures during laparoscopic cholecystectomy ( LC).
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age ≥ 18 years 2 Gall stone disease patients with moderate and high risk of difficult cholecystectomy on preoperative risk assessment scale 3 Hemodynamically stable 4 Fit for General anaesthesia • Laparoscopic cholecystectomy indicated either interval or immediate( within 72 hrs of presentation).
排除标准
- •1 Allergy to Indocyanine green (ICG) 2 Patients with low risk of difficult cholecystectomy on preoperative risk assessment scale 3 Patient for which consent could not be obtained.
结局指标
主要结局
Operative time from insertion of ports to achieving critical view of safety (CVS).
时间窗: once on operation table
次要结局
- blood loss(once on operation table)
- Bile duct injury(once on operation table)
- Conversion to open(once on operation table)
- Post operative bile leak(once on operation table)
- Hospital stay(once on operation table)
研究者
Dr Anita Dhar
ALL INDIA INSTITUTE OF MEDICAL SCIENCES