ACTRN12623000950662招募中Unknown
Effect of intraoperative warmed, humidified carbon dioxide insufflation in open laparotomy colorectal surgery on 5-year survival rates of patients undergoing Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS HIPEC): a randomized controlled trial (Second WHCO2 trial)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Colorectal adenocarcinoma peritoneal metastases confirmed on biopsy at time of diagnostic laparoscopy, Peritoneal cancer index score (diagnostic laparoscopic) <15, Intention to achieve Completeness of cytoreduction score (CCR) of 0. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
排除标准
- •Extraperitoneal metastasis (current),
- •Liver metastases,
- •Non-colorectal adenocarcinoma,
- •Inability to achieve CCR0,
- •Inoperable peritoneal carcinomatosis ,
- •PCI on diagnostic laparoscopy of more than 15,
- •During laparotomy for CRS/HIPEC, two surgeons agree and decide tumour spread is so advanced that proceeding with operation is futile or too dangerous (however will be analysed as intention to treat),
- •ECOG score >2,
- •Charlson Comorbidity index more than 8,
- •PCI (diagnostic laparoscopic)>16
研究者
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