Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Open Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
研究概览
简要总结
To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.
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
- •patients undergoing open radical surgery for colorectal cancer
- •age over 18 years
- •signed informed consent
排除标准
- •intolerance of the study drugs
- •history of CRC surgery
- •neoadjuvant therapy
- •contraindications to epidural analgesia
- •other malignancy not in permanent remission
- •chronic opioid medication or opioid administration within 7 days preoperatively
- •immunosuppressive or corticosteroid therapy
- •surgery within 30 days preoperatively (except minor)
- •chronic or acute infection
研究组 & 干预措施
Morphine
Morphine-based perioperative analgesia
干预措施: Morphine (Drug)
Piritramid
Piritramid-based perioperative analgesia
干预措施: Piritramid (Drug)
Epidural
Perioperative epidural analgesia containing an opioid
干预措施: Epidural (Drug)
结局指标
主要结局
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
时间窗: 1 - 3 days before surgery to 4 weeks after surgery
Baseline number of circulating tumor cells will be recorded prior to surgery in a venous blood sample. Number of circulating tumor cells will be measured 2 - 4 weeks after surgery in a venous blood sample. These two values will be compared.
次要结局
- Pain assessment(3 days postoperatively)