A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 550
- 试验地点
- 7
- 主要终点
- Incidence of surgical complications
研究概览
简要总结
In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer.
详细描述
Based on investigators' experience, compared to robotic-assisted colorectal cancer radical resection, robotic colorectal cancer radical resection with natural orifice extraction has more advantages in postoperative stress response, postoperative pain, postoperative recovery and postoperative abdominal aesthetics. However, in terms of tumor radicality, there may be no obvious differences. There are no randomized controlled trails to discuss these questions.This research is based on the above conditions. Investigators use prospective randomized controlled trial to analyze the surgical data, postoperative complications, postoperative recovery of the robotic colorectal cancer radical resection with natural orifice extraction and conventional robotic-assisted colorectal cancer radical resection in order to summarize clinical experience and explore the advantages and disadvantages of robotic colorectal cancer radical resection with natural orifice specimen extraction and to provide a new direction for the surgical treatment of colorectal cancer, which is beneficial to the promotion of NOSES(Natural Orifice Specimen Extraction Surgery ) technology and treatment of colorectal cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years;
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- •Histological or cytological confirmation of colorectal adenocarcinoma;
- •High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;
- •T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of <5 cm;
- •Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;
- •Cardiopulmonary liver and kidney function can withstand surgery;
- •Written informed consent for participation in the trial.
排除标准
- •Not suitable for robot laparoscopic surgery;
- •The tumor is too large to be pulled out through the anus or vagina;
- •Simultaneous multiple primary cancer;
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer
- •Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.
结局指标
主要结局
Incidence of surgical complications
时间窗: 30 days
Complication rate of surgery within 30 days after surgery.
次要结局
- The variation of C-reactive protein(Preoperative 3 days and postoperative 1, 3, and 7 days)
- The variation of interleukin-6(IL-6)(Preoperative 3 days and postoperative 1, 3, and 7 days)
- The positive rate of malignant cells in ascitic fluid specimen(1 day)
- The positive rate of bacterial culture in ascitic fluid specimen(1 day)
- Postoperative pain score(1 day)
- Time to first flatus(30 days)
- Time to leave bed postoperatively(30 days)
- The variation of interleukin-10(IL-10)(Preoperative 3 days and postoperative 1, 3, and 7 days)
- The variation of cortisol(Preoperative 3 days and postoperative 1, 3, and 7 days)
- The variation of lymphocyte subsets count of CD3, CD4 and CD8(Preoperative 3 days and postoperative 1, 3, and 7 days)
- Postoperative hospital stay(30 days)
- Operation time(1 day)
- Time to first liquid diet postoperatively(30 days)
- Estimated blood loss(1 day)
- Number of retrieved lymph nodes(1 day)
研究者
Taiyuan Li
Prof., Chief physician, Head of The Fifth Department of General Surgery
The First Affiliated Hospital of Nanchang University