Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change of strategy
研究概览
简要总结
This is a prospective, multicentre, non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green (ICG) in all-cause bowel ischemia.
At intraoperative finding of bowel ischemia, the initial intraoperative plan is noted and resection margins marked with a steril pen. A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused, whether there is a change in the resection margins in centimeters, and if the intraoperative plan has changed. If resection is indicated and the strategy of choice is an anastomosis, a renewed fluorescence angiography will be performed to assess anastomotic perfusion.
详细描述
Fluorescence guided-surgery utilises the fluorescent property of a fluorophore, indocyanine green (ICG), injected intravenously to assess perfusion and viability of the bowel.
This study aims to evaluate the usability and feasibility of ICG to assess bowel viability in an emergency abdominal surgery setting where all-cause bowel ischemia is suspected and intraoperatively present. The investigators aim to evaluate whether ICG fluorescence angiography contributes as an intraoperative aid and changes the intraoperative strategy.
The investigators hypothesize that ICG is a safe and reliable aid in intraoperative decision-making regarding mesenteric ischemia. It may lead to an increasing number of one-step definitive procedures with vital resection margins, primary anastomosis and reducing stomas, and second-look procedures.
In this prospective, non-randomized cohort study bowel viability will be assessed using intraoperative real-time visualization by performing an ICG-fluorescence angiography when there is intraoperative finding of bowel ischemia.
Intraoperatively, ICG (Verdye, Diagnostic Green GmbH 25 mg vials) are dissolved with 5 ml sterile water obtaining a concentration of 5 mg/ml. 0,2mg/kg will be administered intravenously at one to two steps of perfusion assessment.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients >18 years of age
- •Acute physiologic derangement and suspected of having bowel ischemia
- •Intraoperative finding of all-cause bowel ischemia with subsequent acute physiologic derangement
排除标准
- •Allergy toward; iodine, indocyanine green, or shellfish
- •Liver insufficiency
- •Thyrotoxicosis
- •Pregnancy or lactation
- •Permanently legally incompetent for any reason
结局指标
主要结局
Change of strategy
时间窗: Assessed at day 30 and 90 after surgery
Change of intraoperative strategy due to ICG fluorescence angiography. Intraoperatively, a nurse will record the initial strategy, indication of resection in centimeters, before and after ICG angiography, and note whether there has been a change in strategy, and how.
次要结局
- Postoperative medical complications(Assessed at day 30 and 90 after surgery)
- Postoperative surgical complications(Assessed at day 30 and 90 after surgery)
- Anastomosis(Assessed at day 30 and 90 after surgery)
- Quantification using q-ICG(30 months)
- Stomas(Assessed at day 30 and 90 after surgery)
- Mortality(90 days)
- Second-look(Assessed at day 30 and 90 after surgery)
- Anastomotic leaks(Assessed at day 30 and 90 after surgery)
研究者
Michael Patrick Achiam
Professor, MD, PhD, DMSc
Rigshospitalet, Denmark