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临床试验/NCT04972149
NCT04972149Unknown不适用

Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年5月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
complication

研究概览

简要总结

A new surgical instrument is supposed to allow surgeon to do surgery with better performance. However, the learning period before getting used to the new instruments is necessary. The surgeon's stress to overcome the learning effect and the surgical outcome was rarely assessed. The comparative analysis of surgical outcome, surgeon's stress, and utilization of instruments for gastrectomy will be performed in prospective cohort study

详细描述

Before the surgery, all the eligible patients will be explained regarding the study and informed consent will be given. During the surgery, the surgeon will wear heart rate monitoring device to monitor hear rate variability of the surgeon. The surgical procedure will be recorded. After the surgery, morbidity following surgery will be monitored and recorded. At 1 month after surgery, additional morbidity will be recorded.

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
— 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with gastric cancer scheduled for gastrectomy

排除标准

  • Vulnerable subject (illiterate, pregnant)

结局指标

主要结局

complication

时间窗: 1 month after surgery

One of the most important surgical outcome, complication will be measured at 1 month after surgery

次要结局

  • gas passing(day)(1 month after surgery)
  • hospital stay(day)(1 month after surgery)
  • number of use for each surgical instruments(during the operation)
  • Heart rate variability of surgeon(during the operation)
  • Duration for each surgical instruments(during the operation)
  • bleeding(ml)(1 month after surgery)
  • readmission rate(percent)(1 month after surgery)
  • operative time (min)(1 month after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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