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临床试验/NCT03776370
NCT03776370已完成不适用

A Clinical Cohort Study on the Effect of Preserving Left Colonic Artery During Radical Resection of Rectal Cancer on Anastomotic Leakage and Oncology Efficacy

Third Military Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018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
入组人数
200
试验地点
1
主要终点
The incidence of postoperative anastomotic leakage was compared between the two groups.

研究概览

简要总结

To evaluate the feasibility and clinical significance of preserving left colonic artery in rectal cancer surgery.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.

详细描述

The investigators performed three-dimensional (3D) reconstruction to investigate the vascular anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help make pre-operative strategies of rectal cancer surgery.The investigators will preserving the left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical significance.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Pathological biopsy confirmed adenocarcinoma of the rectum;
  • Preoperative assessment of tolerance to surgery without major organ dysfunction;
  • Patients must be able to understand and voluntarily sign written informed consent;
  • The surgical method is laparoscopic or robotic anterior rectal cancer resection.

排除标准

  • The patient cannot tolerate the operation;
  • Refusal to sign informed consent;
  • Patients with distant metastasis of rectal cancer;
  • The surgical method was changed to miles or Hartman;
  • Unable to complete the follow - up

结局指标

主要结局

The incidence of postoperative anastomotic leakage was compared between the two groups.

时间窗: Within 30 days after surgery

The incidence of anastomotic leakage within 30 days after surgery was compared between the intervention group and the control group.

The distant metastasis rates of rectal cancer between the two groups were compared.

时间窗: Two years after surgery

The incidence of distant metastasis rectal cancer within two years after surgery was compared between the intervention group and the control group.

The five-year survival rates of rectal cancer between the two groups were compared.

时间窗: Five years after surgery

The 5-year survival rates of rectal cancer in the intervention group and the control group were compared.

The local recurrence rates of rectal cancer between the two groups were compared.

时间窗: Two years after surgery

The incidence of local recurrence rectal cancer within two years after surgery was compared between the intervention group and the control group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weidong Tong

Clinical Professor

Third Military Medical University

研究点 (1)

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