A Prospective Study to Investigate the Impact of Using Indocyanine Green-enhanced Fluorescence Imaging on the Location of Bowel Transection in Patients Undergoing Left-sided Colorectal Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of patients with operative decisions changed after the use of ICG enhanced fluorescence imaging
研究概览
简要总结
The aim of this study was to evaluate the impact of fluorescence imaging on the location of colorectal transection lines based on evaluation of perfusion with indocyanine green, how it's going to affect surgical planning and its possible benefits in reducing anastomotic leakage.
详细描述
During surgery, the line of intended bowel transection would be determined by the surgeon. Then the anesthesiologist will administer a bolus of 5mg ICG intravenously (2.5mg/ml, 2ml), followed by 10ml normal saline flush. The perfusion of colon will be assessed via fluorescence angiography. The actual bowel transection, after ICG fluorescence study, would be compared with the intended bowel transection site. The difference in terms of distance and either more proximal or distal is recorded. Then bowel anastomosis is completed in the usual manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All left-sided colorectal resection involving division of inferior mesenteric artery
排除标准
- •Patients with a history of adverse reaction or known allergy to ICG, iodine, or iodine dyes. Pregnant and/or lactating patients.
研究组 & 干预措施
ICG
Administering indocyanine green during surgery and the use of ICG fluorescence imaging to assess bowel perfusion during surgery
干预措施: indocyanine green (Drug)
ICG
Administering indocyanine green during surgery and the use of ICG fluorescence imaging to assess bowel perfusion during surgery
干预措施: Fluorescence imaging (Device)
结局指标
主要结局
Number of patients with operative decisions changed after the use of ICG enhanced fluorescence imaging
时间窗: intraoperative
次要结局
- Anastomotic leak(up to 2 weeks after operation)
研究者
Dr. Dominic C.C. Foo
Clinical Assistant Professor
The University of Hong Kong