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临床试验/NCT05707598
NCT05707598已完成不适用

Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 638 人开始时间: 2023年1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
638
试验地点
1
主要终点
Complications

研究概览

简要总结

This study attempts to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b Colorectal cancer.

详细描述

Laparoscopic surgery is controversial for patients with T4b colorectal cancer who require multivisceral resection. With the expansion of the indications for laparoscopic surgery in recent years, surgeons try to perform laparoscopic multivisceral resection for the treatment of clinical T4b colorectal cancer. In this study, investigators attempted to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b colorectal cancer.

This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization. According to the operation method, the patients were divided into laparoscopic multivisceral resection group(patients who underwent laparoscopic surgery or conversion to open surgery) and open multivisceral resection group(patients who underwent open surgery directly). The short-term and long-term result was compared between groups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • The patient was pathologically diagnosed as colorectal adenocarcinoma by endoscopic biopsy before operation.
  • All patients were considered to have tumors invading adjacent organs after preoperative radiographic evaluation.
  • All patients were recommended to undergo radical surgery after preoperative multidisciplinary consultation.

排除标准

  • Patients with distant metastasis or recurrent colorectal cancer were excluded.

结局指标

主要结局

Complications

时间窗: Until the patient recovered and was discharged from the hospital, an average of 10 days.

Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.

Hospital stay after surgery

时间窗: Until the patient recovered and was discharged from the hospital, an average of 10 days.

Hospital stay after surgery is defined as the length of time from the end of surgery to the discharge of patient, which is measured in days.

Blood loss

时间窗: Until the end of the operation, an average of 8 hours.

Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).

次要结局

  • Overall survival(The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.)
  • Disease-free survival(The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 72 months.)

研究者

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

Jianqiang Tang

Associate professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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