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临床试验/NCT06814093
NCT06814093进行中(未招募)不适用

Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial

Xu jianmin1 个研究点 分布在 1 个国家目标入组 2,702 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,702
试验地点
1
主要终点
3-year postoperative disease-free survival rate

研究概览

简要总结

This study aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. By using real-world data from a specialized multicenter colorectal cancer database in Shanghai, China, this retrospective cohort study will emulate the target trial to evaluate whether robotic surgery offers advantages over laparoscopic surgery. Key factors such as disease-free survival, locoregional recurrence, circumferential margin positivity, and postoperative complications will be examined. The goal is to provide stronger, evidence-based support for the clinical use of robotic surgery in treating low rectal cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

3-year postoperative disease-free survival rate

时间窗: From surgery to three years postoperatively

Disease-free survival event is defined as any death or locoregional recurrence or distant metastases.

次要结局

  • Circumferential resection margin positivity rate(14 days during postoperative pathological examination)
  • 30-day postoperative complication rate (Clavien-Dindo grade 2 or higher grade)(From surgery to 30 days postoperatively)
  • rate of abdominoperineal resection(30 days after surgery)
  • 3-year postoperative locoregional recurrence rate(From surgery to three years postoperatively)

研究者

发起方
Xu jianmin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xu jianmin

Director of Colorectal Surgery

Fudan University

研究点 (1)

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