A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 978
- 试验地点
- 1
- 主要终点
- 90-days Anastomotic Leakage (AL) rate
研究概览
简要总结
Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.
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
- •Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
- •Patients aged over 18 years old;
- •Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
- •Signed informed consent prior to any study-mandated procedure;
排除标准
- •Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
- •Severe liver or kidney insufficiency;
- •Hyperthyroidism or a benign thyroid tumour;
- •Pregnant or breastfeeding women;
- •Scheduled for palliative surgery or terminal ill
- •Scheduled for a diverting stoma
- •Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination;
- •Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
- •Emergency surgery
研究组 & 干预措施
Image Guided Bowel Anastomosis group
ICG-guided perfusion assessment
干预措施: ICG-guided bowel perfusion assessment (Drug)
结局指标
主要结局
90-days Anastomotic Leakage (AL) rate
时间窗: 90 days
Anastomotic leakage rate
次要结局
- days in hospital stay(90 days)
- mortality(90 days)
- complication rate(90 days)
- 30-days Anastomotic Leakage ( AL) rate(30 days)
研究者
Alexander Vahrmeijer
Principal Investigator
Leiden University Medical Center