NCT00782457已完成3 期
Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer
Hospital Universitario Virgen de la Arrixaca0 个研究点目标入组 200 人开始时间: 2002年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
研究概览
简要总结
The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
- •Histology of adenocarcinoma
排除标准
- •Locally advanced disease (T4)
- •Emergency surgery
- •Rectal cancer over familial colic polyposis
结局指标
主要结局
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
时间窗: 1 month
次要结局
未报告次要终点
研究者
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