NCT05566249招募中不适用
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Cost
研究概览
简要总结
This study is to validate the safety and feasibility of ArtiSential (Articulating laparoscopic instrument) colorectal surgery and compare it with robotic surgery for patients with rectal cancer and rectosigmoid junction cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age : 18 ~ 80 year old male or female
- •Biopsy-proven adenocarcinoma
- •Rectal cancer or Rectosigmoid junction cancer
- •Primary cancer
- •Non-metastatic cancer
- •Planned (or elective) curative resection
- •Low anterior resection with double-stapled technique
排除标准
- •Preoperative systemic chemotherapy
- •Distant metastasis at initial diagnosis
- •Palliative surgery
- •Emergent surgery
- •Lynch syndrome or FAP-associated cancer
结局指标
主要结局
Cost
时间窗: 1 month
Total medical cost during hospital stay for surgery
Surgical failure
时间窗: 1 month
conversion, postoperative complications, or less than 12 harvested lymph nodes
次要结局
- Oncologic outcomes(5-year)
研究者
Jung Wook Huh
Professor
Samsung Medical Center
研究点 (1)
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