Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of anastomotic leakage
研究概览
简要总结
This is a prospective cohort pilot study. The investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation will determine the final anastomotic leak risk.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 year
- •signed written consent
- •a colorectal anastomosis lower 15 cm from anal verge
- •elective surgery
排除标准
- •allergy to indocyanine green dye
- •pregnancy
结局指标
主要结局
Rate of anastomotic leakage
时间窗: 0 to 60 days
The number of patients, who had clinical or radiological anastomotic leakage. Proctography will be performed 6-8 days and 4-6 weeks after the primary operation.
次要结局
- Time of anastomosis testing(0 to 600 minutes)
- Operation time(0 to 600 minutes)
- 90 days mortality(0 to 90 days)
- Intraoperative test leakage(0 to 600 minutes)
- Reoperation rate(0 to 60 days)
- Timing of anastomosis leakage(0 to 60 days)
- Quality of life before and after the operation(0 to 60 days)
研究者
Marius Kryzauskas
Principal investigator
Vilnius University