A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- 5 years diseases free survival rate
研究概览
简要总结
The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.
详细描述
Study type：Interventional Study phase：Phase III Objectives of Study：to verify the 5-year DFS of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.
Study design：Randomized parallel control
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line
- •cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm
- •age less than 80 years old
- •normal blood routine test and hepatic or renal function test
- •no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction.
排除标准
- •severe comorbidity such as heart attack or stroke, malignance in 5 years
- •can not tolerate to general anesthesia, pneumoperitoneum or surgery
- •pregnant or during breast-feeding period
- •attending other clinical trial involving therapy
- •cannot or disagree to attending the clinical trial
研究组 & 干预措施
open surgery
Conventional procedure
干预措施: open surgery (Procedure)
laparoscopic surgery
Minimum invasive procedure
干预措施: laparoscopic surgery (Procedure)
结局指标
主要结局
5 years diseases free survival rate
时间窗: five years
5 years overall survival rate
时间窗: five years
次要结局
未报告次要终点
研究者
Cai Kailin
Associate chief physician of gastrointestinal surgery
Huazhong University of Science and Technology