NCT01899547Unknown不适用
Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum : A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 1,070 人开始时间: 2013年11月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,070
- 试验地点
- 1
- 主要终点
- 3 years disease-free survival
研究概览
简要总结
The purpose of this study is to evaluate the safety and oncological feasibility of laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.
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
- •histologically proven rectal adenocarcinoma
- •inferior edge of the tumor located within 5 cm from the dentate line as determined by rigid proctoscopy
- •diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision
- •T3-4a,N0 or T1-4a,N1-2 treated with neoadjuvant chemoradiotherapy
- •no evidence of distant metastases
- •tumor size <6cm
- •sufficient organ function
- •no contraindication to laparoscopic surgery
- •without other malignancies in medical history
排除标准
- •concurrent or previous diagnosis of invasive cancer within 5 years
- •locally advanced cancers requiring en bloc multivisceral resection
- •intestinal obstruction
- •intestinal perforation
- •history of colorectal surgery
- •American Society of Anesthesiologists(ASA) class 4 or 5
- •pregnant or breast-feeding women
- •history of mental disorder
- •participation in another rectal cancer clinical trial relating to surgical technique
研究组 & 干预措施
Arm I
Experimental
Patients undergo laparoscopic-assisted rectal resection.
干预措施: laparoscopic-assisted rectal resection (Procedure)
Arm II
Active Comparator
Patients undergo conventional open rectal resection.
干预措施: conventional open rectal resection (Procedure)
结局指标
主要结局
3 years disease-free survival
时间窗: 3 years
Disease-free survival is defined as the time from date of surgery to the date of rectal cancer recurrence or metastasis or cancer-related death (locoregional or distant recurrence) .
次要结局
- 30-day postoperative complications(1 month within operatively)
- Overall survival(3 and 5 years post operatively)
- Pathologic outcomes(1 week post operatively)
- Locoregional recurrence rate(3 and 5 years post operatively)
- 30-day postoperative mortality(30 days post operatively)
研究者
Pan Chi, MD
Chief of Department of General Surgery, Fujian Medical University Union Hospital
Fujian Medical University Union Hospital
研究点 (1)
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