A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 377
- 试验地点
- 2
- 主要终点
- Anastomotic Leak Rate
研究概览
简要总结
This is a randomized, controlled, parallel study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated using fluorescence angiography with indocyanine green and without this method.
详细描述
The design involves random allocation of eligible patients to operation with colorectal anastomosis and intraoperative fluorescence angiography with indocyanine green and operation alone. After surgery on 7-8 POD patients are examined to two sides X-Ray proctography performed by introducing 100 ml of water-soluble liquid contrast material through the anus over the anastomotic line by a Foley catheter for diagnosis of anastomotic leakage.
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
- 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
- •Have a planned circular stapled colorectal anastomosis
- •Have signed an approved informed consent form for the study
排除标准
- •Has known allergy or history of adverse reaction to indocianyne green, iodine or iodine dyes.
结局指标
主要结局
Anastomotic Leak Rate
时间窗: 0 to 30 days
次要结局
未报告次要终点
研究者
Rybakov Evgeny, MD
Dr.Med.Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation
State Scientific Centre of Coloproctology, Russian Federation