NCT01591798Unknown2 期
Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Quality of mesorectal excision
研究概览
简要总结
After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.
详细描述
This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mid or low rectal cancer (within 9cm from anal verge)
- •pathologically proven as adenocarcinoma
- •written informed consent
- •no severe functional disability in lung and heart
排除标准
- •invading adjacent organ
- •distant metastasis (lung, liver, brain, bone, distant lymph nodes etc.)
- •lateral pelvic lymph node metastasis
- •Have severe concomitant disease that might limit compliance or completion of the protocol.
- •Have any other malignancy that might impact 5-year survival or might be potentially confused with rectal cancer.
- •If female, be pregnant or breast feeding.
- •Hereditary colorectal cancer (HNPCC, FAP etc)
- •emergency operation
结局指标
主要结局
Quality of mesorectal excision
时间窗: 7days after surgery (Pathologic report)
Evaluating the quality of mesorectal excision in rectal specimen according to the criteria suggested by Nagtegaal ID, et al. (J Clin Oncol. 2002;20:1729-34)
次要结局
- Short-term postoperative outcome(Within postoperative 30 days)
- Sexual and urinary function, Quality of life, Anorectal function(Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months)
- Long-term outcome(Postoperative 36 months)
研究者
Ji Won Park
Principal Investigator
National Cancer Center, Korea
研究点 (2)
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