Randomized Controlled Trial: Clinical Value of Preserving Left Colic Artery in Laparoscopic Radical Rectectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Colorectal cancer is one of the most common tumors in Asia. According to the recent research, surgical procedure could provide more treatment benefit in rectal cancer. Therefore, it was consider that important to standardized and improved the surgical procedure for rectal cancer. With the development of anatomical technique, minimally surgery with laparoscopy had become the trend for surgical treatment. There were several studies has been done to evaluate the safety and feasibility of laparoscopic surgery. In order to achieve better surgical outcome and reduce operative complications, the investigators design stratified randomization, double blinded, muti - center clinical trail to investigate the value of left colic artery in laparoscopic radical rectectomy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged more then 18 years old;
- •Diagnosed as rectal cancer with colonoscopic biopsy;
- •Without metastasis;
- •No Invasion of surrounding tissues;
- •Limited operation;
- •Underwent laparoscopic radical proctectomy(L-Dixon);
- •BMI 18~30kg/m2;
- •Without multiple primary tumors;
- •Sign on the Medical informed Consent.
排除标准
- •Simultaneous or simultaneous multiple primary colorectal cancer;
- •Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
- •History of any other malignant tumor in recent 5 years;
- •Patients need emergency operation;
- •Not suitable for laparoscopic surgery;
- •Women during Pregnancy or breast feeding period;
- •Informed consent refusal
研究组 & 干预措施
LCA-nP
The group underwent laparoscopic radical rectectomy without preserving left colic artery. In IMA group, the dissecting based on TME is performed without preserving left colic artery. Surgeon should dissect the lymph nodes and ligated the vessel in the root of inferior mesenteric artery.
干预措施: LCA-nP (Procedure)
LCA-P
The group underwent laparoscopic radical rectectomy with preserving left colic artery. In LCA group, the dissecting based on TME is performed with preserving left colic artery. The relationship of inferior mesenteric artery, inferior mesenteric vein and LCA should be identified and ligated separately without LCA.
干预措施: LCA-P (Procedure)
结局指标
主要结局
Disease-free survival
时间窗: 3 years
次要结局
- 3 years overall survival(3 years)
- The rate of LN.253 metastasis(2 weeks)
- The rate of local and distant recurrence(3 years)
- The rate of postoperative coml[ications and mortality(30 days)