Inflammatory Response Following Colorectal Cancer Surgery Depends on the Type of Anesthesia and Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Plasma levels of several cytokines after colorectal cancer surgery
研究概览
简要总结
Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. The investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general anesthesia.
详细描述
Patients scheduled for open colorectal cancer surgery were randomly allocated to receive general anesthesia (CON group, n=22) or general anesthesia with thoracic epidural anesthesia (EPI group, n=21). Patients undergoing laparoscopic surgery (LAP group, n=20) composed the third arm of the study. Measurement of perioperative changes in several hormones and cytokines were blinded to group assignment.
Primary outcome: Compare simultaneously two types of surgical and anesthesia techniques for colorectal cancer surgery and measure to what extent the stress response is lessened.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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 scheduled for colorectal cancer surgery
排除标准
- •Emergent surgery
- •Intestinal obstruction
- •Contraindication for epidural catheter placement
- •Concomitant autoimmune disease
- •Concomitant infectious disease
- •Recent corticosteroids or anti-inflammatory medications
研究组 & 干预措施
Control group
Control group: open surgery under general anesthesia
干预措施: Laparoscopic technique and thoracic epidural anesthesia (Procedure)
Epidural group
Epidural group: Open surgery under thoracic epidural anesthesia
干预措施: Laparoscopic technique and thoracic epidural anesthesia (Procedure)
Laparoscopic group
Laparoscopic group: Laparoscopic surgery under general anesthesia
干预措施: Laparoscopic technique and thoracic epidural anesthesia (Procedure)
结局指标
主要结局
Plasma levels of several cytokines after colorectal cancer surgery
时间窗: within the first two days after surgery
We have measured and compared perioperative plasma levels of interleukin-1, interleukin-2, interleukin-6,monocyte chemotactic protein-1, interleukin-8, nitric oxide, C-reactive protein and procalcitonin in our three-group sample.
次要结局
- Incidence of adverse clinical outcomes between groups(within 30 days after surgery)
研究者
Patricia Duque, M.D.
Anesthesiologist staff
Universidad Complutense de Madrid