Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Peak value of surgically induced C-reactive protein (CRP), expected to occur 1-3 days after surgery
研究概览
简要总结
The intention of the study is to explore metabolic and inflammatory parameters in the pelvis and systemically after abdominoperineal resection (APR) for locally advanced rectal cancer (LARC) in patients that have received radiation therapy before surgery. In this study the inflammatory response after laparoscopic robot-assisted APR for LARC will be compared to results obtained in a recent cohort of patients operated with open APR for LARC, which will serve as the control population.
详细描述
Locally advanced rectal cancers (LARC) threaten the normal surgical margins and therefore needs neoadjuvant (chemo-) radiotherapy to down-stage the tumor before surgery. The Norwegian Radium Hospital Oslo University Hospital is a regional center for treatment of LARC in the south-eastern part of Norway and treat approximately 80-100 patients in this category annually. About 50 of these patients receive abdominoperineal resection (APR) as the main surgical treatment.
Laparoscopic surgery in LARC has been limited because of difficult dissection with straight instruments outside the normal anatomical planes in the confined space of the pelvis. However, recent papers report on better feasibility and good results in robot-assisted surgery for LARC. In respect to shorter postoperative length of stay for minimally invasive compared to open surgery, reduced inflammation may be the explanation, however, results are not conclusive. Most studies comparing open to minimally invasive surgery in colorectal cancer have had conventional laparoscopy as the minimally invasive group, including studies comparing inflammation after surgery. A study on inflammation after laparoscopic robot-assisted major surgery for bladder cancer has recently been published, but to our knowledge no comprehensive studies have been done with patients with rectal cancer resections. Additionally, there are claims that excessive and/or dysregulated inflammatory response after cancer surgery, worsen oncologic outcome. The need to characterize the inflammatory response after laparoscopic robot-assisted surgery of rectal cancer is thus highly relevant and needed.
The investigators want to analyse inflammatory parameters in plasma and peritoneal fluid in patients undergoing robot-assisted and open surgery for LARC.
Microdialysis is a technique which enables close to real-time monitoring of the tissues and organs of interest. The investigators want to utilize the microdialysis method to describe and monitor metabolic and inflammatory parameters in some patients after extensive robot-assisted oncological surgery for LARC.
The investigators hypothesize inflammatory response differ between patients undergoing open versus robot-assisted surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary rectal adenocarcinoma that have received radiation ≥25 Gy to the pelvis.
- •operation with APR with laparoscopic robot assisted technique.
- •have accepted and signed the consent form.
排除标准
- •APR for other reasons
结局指标
主要结局
Peak value of surgically induced C-reactive protein (CRP), expected to occur 1-3 days after surgery
时间窗: December 2022
CRP will be measured prior to surgery as well as on a daily basis the first 4 postoperative days. Peak values of CRP will be compared between patients undergoing open versus robot-assisted surgery.
次要结局
- Overall survival at 1 year follow up after surgery(December 2024)
- Progression-free survival at 1 year follow up after surgery(December 2024)
- Operating time in minutes(December 2023)
- Hospital length of stay in days after primary surgery(December 2023)
- Postoperative deep pelvic surgical site infection within 30 days after primary surgery(December 2023)
- Superficial wound infection within 30 days after primary surgery(December 2023)
- Dehiscence of the perineal wound at 3 months follow-up(December 2023)
研究者
Ebbe Billmann Thorgersen
Principal Investigator
Oslo University Hospital