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
干预措施
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
- •Elective robotic-assisted or laparoscopic surgery for right-sided, left-sided and sigmoid colon cancer
- •Aged ≥ 18
- •ASA-score ≤ 3
- •Tumor-stage (Tx-T4a)
- •Endoscopic suspected colon cancer
- •Histological verified adenocarcinoma, signet ring cell carcinoma, undifferentiated cancer, medullary carcinoma, or another malignant tumor type originating from colon
- •Patients must give informed written consent
- •Patients must be able to understand Danish language
排除标准
- •Carcinoma of the transverse colon or synchronous colorectal cancer
- •Previous history of colon cancer
- •Previous open major abdominal surgery with exception of open appendectomy and cholecystectomy.
- •Metastatic disease
- •Pregnancy
- •History of psychiatric or addictive disorder that would prevent the patient from participating in the trial
- •Emergency colon surgery
- •Co-existing inflammatory bowel disease
- •Co-existing immunological disease that requiring ingestion of systemic immunomodulatory drugs (DMARD - disease modifying anti-rheumatic drugs), corticosteroids and biologic disease-modifying anti-rheumatic drugs.
- •Daily consumption of NSAID drugs
研究组 & 干预措施
Robotic-assisted surgery
Experimental
Patients undergoing robotic-assisted colectomy for colonic neoplasm
干预措施: Robotic-assisted colectomy (Procedure)
Laparoscopy
Active Comparator
Patients undergoing conventional laparoscopic colectomy for colonic neoplasm
干预措施: Conventional laparoscopic colectomy (Procedure)
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)
- Postoperative pain(Baseline and postoperative (day 1-3 and 14))
- 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)
- 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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