A Randomized, Controlled, Multicenter, Noninferiority Study of Perioperative and Oncological Safety of Transanal Laparoscopic Radical Resection of Low Rectal Cancer (NOSES I) Compared With Conventional Laparoscopic Assisted Surgery for Low Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- disease-free survival rate
研究概览
简要总结
Laparoscopic natural orifice specimen extraction surgery (NOSES) for low rectal cancer has a good minimally invasive effect. However, the NOSES prognosis studies are all small sample retrospective studies. This study conducted a multicenter prospective randomized controlled trial of NOSES surgery for low rectal cancer to compare the difference in surgical outcomes between conventional laparoscopic surgery and NOSES surgery for low rectal cancer. A total of 500 patients were planned to be enrolled, including 250 in the control group and 250 in the experimental group. The primary end point was 2-year disease-free survival (DFS), and the secondary end points were surgical safety, postoperative pathology, postoperative defecation, urination, and sexual function. Through a large sample size study, this study aims to clarify the advantages of NOSE surgery for low rectal cancer, promote the promotion of low rectal cancer NOSES surgery in the country, standardize the way of low rectal cancer NOSES surgery, improve the surgical treatment of patients with low rectal cancer, improve the quality of life of patients, reduce the burden of patients, and increase the satisfaction. And improve the international influence of the project team in the field of minimally invasive surgical treatment of colorectal cancer.
详细描述
Research Objectives:
- To compare the difference in the oncological effect between laparoscopic radical resection of low rectal cancer with anal specimens (NOSES I type) and laparoscopic assisted surgery for low rectal cancer;
- To compare the safety of laparoscopic radical resection of low rectal cancer with anal specimens (NOSES I type) and laparoscopic assisted surgery for low rectal cancer within 30 days of perioperative period;
- To explore the difference in the prophylactic stoma implementation and the positive rate of tumor cells in pelvic flushing fluid between laparoscopic radical resection of low rectal cancer with anal specimens (NOSES I) and laparoscopic assisted resection of lower rectal cancer.
Primary end Point: 2-year Disease-free survival (DFS) Secondary end points :(1) incidence of SSI; (2) Incidence of serious postoperative complications (anastomotic leakage, postoperative bleeding, etc.); (3) R0 removal rate; (4) Postoperative recovery (pain, exhaust and defecation time, eating time, postoperative hospital stay, etc.); (5) Postoperative pathological conditions (distance between upper and lower margins, number of lymph nodes, circumferential margins, etc.); (6) 2-year RFS and OS.
Exploratory end points :(1) prophylactic colostomy rate; (2) Positive rate of tumor cells in pelvic flushing fluid.
Inclusion criteria:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were aged between 18 and 75 years;
- •Pathologically confirmed as adenocarcinoma;
- •Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin was ≤ 5cm;
- •Preoperative imaging diagnosis was ct1-3nxm0;
- •Preoperative colonoscopy or imaging diagnosis confirmed that the maximum diameter of the tumor was not more than 5cm;
- •Body mass index (BMI) ≤ 30kg / m2;
- •No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no puncture Formation of pores and abscesses without invasion of adjacent organs);
- •The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
- •Voluntary informed consent.
排除标准
- •Preoperative evaluation of patients with lateral lymph node metastasis;
- •Previous history of malignant tumor;
- •Simultaneous multiple primary colorectal cancer was diagnosed;
- •There are contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency;
- •Patients who had undergone abdominal and pelvic surgery for many times or had extensive abdominal adhesions;
- •Patients with intestinal obstruction, intestinal perforation, intestinal hemorrhage and other emergency operations;
- •Patients with familial adenomatous polyposis, Lynch syndrome associated rectal cancer, and inflammatory bowel disease in the active phase;
- •Have a history of serious mental illness;
- •Pregnant or lactating women;
- •Patients with uncontrolled infection before operation;
- •The investigator considered that the patient should not participate in the trial.
结局指标
主要结局
disease-free survival rate
时间窗: 2-year
After the postoperative review, the patient had no tumor recurrence and metastasis
次要结局
未报告次要终点
研究者
Zhenglou
Associate chief physician and associate professor
Changhai Hospital