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临床试验/NCT04259398
NCT04259398进行中(未招募)不适用

The Influence of Type of Anesthesia on Mortality and Cancer Recurrence After Colon Cancer Surgery: Multi-center Prospective Randomized Controlled Study

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 797 人开始时间: 2020年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
797
试验地点
2
主要终点
five year survival

研究概览

简要总结

This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.

详细描述

The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, total intravenous anesthesia (TIVA) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, there is no randomized controlled study to determine this difference in colon cancer patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults undergoing surgery to remove colon cancer

排除标准

  • pregnancy
  • colon cancer with invasion to perineum
  • palliative surgery
  • history of diagnosis or surgery for other cancer
  • emergent surgery
  • ASA PS classification 4 and 5
  • refusion to participate in the study
  • allergy to anesthetics

研究组 & 干预措施

TIVA

Experimental

propofol infusion targeting bispectral index 40-60

干预措施: Propofol (Drug)

inhalation (Sevoflurane)

Active Comparator

sevoflurane targeting bispectral index 40-60

干预措施: Sevoflurane (Drug)

结局指标

主要结局

five year survival

时间窗: five years survival

survival rate regardless of recurrence

次要结局

  • 3 year survival(3 years after surgery)
  • five year recurrence free survival(five years after surgery)
  • 1 year survival(1 year after surgery)
  • 1 year recurrence free survival(1 year after surgery)
  • 3 year recurrence free survival(3 years after surgery)

研究者

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

Jin-Tae Kim

Professor (full)

Seoul National University Hospital

研究点 (2)

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Anesthesia and Cancer Study: Colon Cancer | 临床试验