The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Anastomotic leak
研究概览
简要总结
The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.
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
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •operative rectal cancer
排除标准
- •known allergy toward indocyanic green
研究组 & 干预措施
Intervention
Intraoperative verdye green iv administration to visualize blood supply to the anastomosis
干预措施: Verdye Green (Drug)
结局指标
主要结局
Anastomotic leak
时间窗: Up to two weeks post surgery
Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line
次要结局
- Postsurgical Ileus(Up to 10 days post surgery)
研究者
Paweł Bogacki
Principle Investigator
Jagiellonian University