NCT00788281Unknown2 期
A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- disease free survival rate
研究概览
简要总结
Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However, whether it has the same survival benefit as the traditional open surgery in Chinese population is still unknown. So we designed this study to evaluate the 3 year disease free survival rate in the laparoscopic group versus the open surgery group.
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
- •Informed consent
- •Pathologically confirmed adenocarcinoma
- •Pre-surgery image staging as (CT/MRI):T2-3,N0-2,M0,(TNM stage，AJCC，version of 2003)
- •Single tumor locating at cecum, ascending colon, descending colon, sigmoid colon, rectosigmoid junction, rectum(distance from anal verge more than 7cm)
- •Tumor diameter less than 6cm
- •Age 18-75 year
- •Predicted survival longer than 6 months
- •Normal liver, renal, bone marrow function: (GPT less than 2 ULN，total bilirubin less than 1.5mg/dl，Cr less than 1.5 ULN，WBC more than 4×109/L，PLT more than 100×109/L)
- •No previous history of gastrointestinal surgery
- •No previous history of chemotherapy or radiotherapy
- •Exclusion criteria
- •Severe and uncontrolled medical disease including unstable angina pectoris, cardiac infarction and cerebral attack in 6 months
- •Could not tolerant general anesthesia or surgery for other organ dis-function
- •Allergy to chemotherapeutical agents in the protocol
- •History of other malignant tumor within 5 years
- •Severe mental disorder
- •Continued systematic steroid therapy
- •Woman during pregnancy or lactation
- •Under study of other clinical trial
- •No compliance of the protocol
- •Discovery of distant metastasis during surgery
- •Postsurgery stage of I or IV tumors
排除标准
- 未提供
结局指标
主要结局
disease free survival rate
时间窗: 3 year
tumor residual rate of LRM and CRM
时间窗: 1 week
operation mortality
时间窗: 2 months
次要结局
- survival rate(5 year)
- local recurrence rate(5 year)
- operation time(at the end of operation)
- blood lost(during operation)
- analgesic dosage(1,2 and 3 days post surgery)
- evacuating time(post surgery)
- operation morbidity(2 months)
- transfer to open surgery(during operation)
- fee(peri-operation)
研究者
研究点 (1)
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