NCT04687384Unknown不适用
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups
研究概览
简要总结
The current hypothesis is that robotic-assisted surgery results in a reduced systemic and peritoneal inflammatory response (SIRS) compared to laparoscopic surgery in the treatment of colon cancer. The purpose is to evaluate differences in the peritoneal and systemic inflammatory response in robot-assisted and laparoscopic surgery of patients undergoing resection for colon cancer in a randomized, blinded controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups
时间窗: Baseline and postoperative (day 1-3)
CRP (mg/L), IL-6 (pg/mL)
次要结局
- Lymph node yield(14 days)
- Changes in levels of systemic inflammation in serum between the two groups(Baseline and postoperative (day 1-3))
- Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI)(30 days)
- Differences in intraoperative blood loss(1 day)
- Conversion rate to open surgery(1 day)
- Length of surgery (total anesthesia time)(1 day)
- Length of surgery (total surgical time)(1 day)
- Length of hospital stay(14 days)
- Postoperative pain(Baseline and postoperative (day 1-3 and 14))
- Time to first flatus(Postoperative (day 1-3))
- Time to first bowel movement(Postoperative (day 1-3))
研究者
研究点 (1)
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