NCT03602677招募中不适用
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,062
- 试验地点
- 2
- 主要终点
- Anastomosis leakage rate
研究概览
简要总结
This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.
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
- 否
入选标准
- •All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study.
- •Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold).
排除标准
- •Emergent patients
- •Patients with proven diverticular abscess and colonic fistulas are excluded
- •Patients with planned open surgery are excluded.
研究组 & 干预措施
ICG fluorescence imaging
Experimental
Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.
干预措施: ICG fluorescence imaging (Device)
Standard procedure
No Intervention
Standard colorectal surgery and anastomosis.
结局指标
主要结局
Anastomosis leakage rate
时间窗: 0 to 90 days
次要结局
- Hospital costs(0 to 90 days)
- Length of hospital stay(0-365 days)
- 30- and 90-day mortality(0 to 90 days)
- Timing of anastomosis leakage(0 to 90 days)
- 30- and 90-day complications according to Clavien-Dindo Classification(0 to 90 days)
- Time to first bowel movement(0-30 days)
- Severity of anastomosis leakage(0 to 90 days)
- Hospital readmission rate(0 to 90 days)
- Deep surgical site infections(0 to 90 days)
- Operation time(0-600 minutes)
- Time to first flatus(0-30 days)
- Reoperation rate(0 to 90 days)
研究者
Olli Helminen
MD, PhD, Resident, Surgery
Oulu University Hospital
研究点 (2)
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