NL-OMON28098招募中不适用
A Phase III, Randomised Controlled Trial Assessing the Value of Indocyanine Green in the Leakage Rate of Colorectal Anastomoses.
Olympus Nederland BV0 个研究点目标入组 978 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 978
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Scheduled for laparoscopic colorectal resection with primary anastomosis;
- •2.Patients aged over 18 years old;
- •3.Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
- •4.Signed informed consent prior to any study-mandated procedure;
排除标准
- •1.Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
- •2.Severe liver insufficiency;
- •3.Hyperthyroidism or a benign thyroid tumour;
- •4.Pregnant or breastfeeding women;
- •5.Scheduled for palliative surgery or terminal ill
- •6.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;
- •7.Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
- •8.Emergency surgery
研究者
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