NCT01203969已完成1 期
Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- rate of 30 day morbidity and mortality
研究概览
简要总结
This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic 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
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologic proven colon cancer
排除标准
- •Tumor located in distal transverse colon, splenic flexure, and descending colon
- •distant metastasis
- •acute obstruction and/or perforation
- •associated with FAP or HNPCC
- •synchronous malignancy
- •ASA score 3 or 4
- •pregnancy
- •no consent
结局指标
主要结局
rate of 30 day morbidity and mortality
时间窗: 1 month
rate of intraoperative complication
时间窗: 1 day
次要结局
- amount of postoperative analgesics usage(5 days)
- Duration of postoperative hospital stay(7 days)
- operation time(1 day)
- degree of postoperative pain(5 days)
- postoperative functional recovery(7 days)
研究者
Byung Mo Kang
Clinical Assistant Professor
Kyunghee University Medical Center
研究点 (2)
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