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临床试验/NCT05498506
NCT05498506已完成不适用

Risk Factors for the Usage of ≥3 Linear Stapler Cartridges During Double Stapling Anastomosis in Laparoscopic Low Anterior Resection of Rectal Cancer

Shanghai Minimally Invasive Surgery Center1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
1
主要终点
the number of linear stapler cartridges

研究概览

简要总结

Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST anastomosis.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • carcinoma of rectum confirmed by histopathological evaluation;
  • tumor located in the mid-low rectum (less than 10cm from the anal verge);
  • performance of DST anastomosis;
  • pelvic MRI obtained within 14 days before surgery.

排除标准

  • other anastomotic techniques (e.g., trans-anal rectal excision);
  • Hartmann's operation or other procedures without anastomosis;
  • the number of linear stapler cartridges was not traceable in the operative report.

结局指标

主要结局

the number of linear stapler cartridges

时间窗: during surgery

the number of linear stapler cartridges used during DST anastomosis

次要结局

未报告次要终点

研究者

发起方
Shanghai Minimally Invasive Surgery Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cai Zhenghao

Director, department of medical-engineering collaboration

Shanghai Minimally Invasive Surgery Center

研究点 (1)

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