NCT02468362Unknown2 期
Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 112
- 主要终点
- Disease Free survival
研究概览
简要总结
Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low rectal cancer below 5 cm from the anal verge
- •Fit for laparoscopic total mesorectal excsion
- •T2, T3 rectal cancer
- •No distant metstasis
排除标准
- •T1, AND T4
- •Distant metastasis
- •Tumor infiltrating the dentate line
- •unwilling to participate
结局指标
主要结局
Disease Free survival
时间窗: 5 years
次要结局
- Local recurrence(5 years)
- 5 year survival(5 years)
- Distant metstasis(5 years)
研究者
Osama Mohammad Ali ElDamshety
surgical oncology
Mansoura University
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