Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Rate of short-term complication
研究概览
简要总结
Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of primary malignant tumor in the colon or rectum;
- •The surgery meets the definition in the "Consensus of NOSES Experts in Colorectal Cancer";
排除标准
- •Postoperative pathological diagnosis does not belong to primary malignant tumors in the colon or rectum;
- •The surgery does not meet the definition in the "Consensus of NOSES Experts in Colorectal Cancer".
结局指标
主要结局
Rate of short-term complication
时间窗: 30 days after surgery
Rate of complications occurred within 30 days after surgery
次要结局
- Time to first flatus after surgery(7 days)
- Intraoperative blood loss(7 days)
- Time to first stool after surgery(7 days)
- Operative duration(7 days)
- Length of stay after surgery(7 days)
- 3-year disease free survival(3 year)
- 3-year overall survival(3 year)