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临床试验/NCT06050447
NCT06050447招募中不适用

Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Immanuel Kant Baltic Federal University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,200
试验地点
1
主要终点
Mortality rate

研究概览

简要总结

The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically proven primary adenocarcinoma of bowel;
  • All patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council;
  • Signed informed consent with agreement to attend all study visits;

排除标准

  • Unresectable tumor or contradictions to surgery;
  • Indications for chemotherapy or radiation therapy prior to surgery;
  • Patient withdrawal from the trial or loss of follow-up;
  • Emergent operation;
  • Pregnancy.

结局指标

主要结局

Mortality rate

时间窗: 3 years after surgery

the overall mortality after colorectal cancer surgery

Anastomotic leakage rate

时间窗: 3 months after surgery

Anastomotic leakage rate after colorectal resection. AL is confirmed by one or more of the following conditions: * fecal discharge from the pelvic drainage at any time after surgery * rectovaginal fistula defined as fecal or mucus discharge from the vagina * pelvic sepsis as defined by the collection of pus/ fecal material in the pelvis documented by CT scan * contrast present outside of the anastomosis as seen by X-Ray contrast enema proctography or CT contrast enema proctography

次要结局

  • Recurrence rate(3 years after surgery)
  • 30-day complication rate(30 days after surgery)
  • Cancer-specific survival(3 years after surgery)
  • Recurrence-free survival(3 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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