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临床试验/NCT05550974
NCT05550974招募中不适用

Articulating Laparoscopic Instrument Assisted Minimally Invasive Upper GastroIntestinal Surgery: AMUGIS Registry

Yonsei University1 个研究点 分布在 1 个国家目标入组 1,155 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,155
试验地点
1
主要终点
complication

研究概览

简要总结

Recently, with the development of minimally invasive surgery and the development of instruments, laparoscopic and robotic surgery are increasing, and laparoscopic and robotic surgery are evolving. The association between the new surgical instruments used in each upper gastrointestinal surgery and the results has been traditionally analyzed through the learning curve, and in addition, the study aims to collect and analyze the utilization of the instrument and surgical results prospectively through surgical video analysis.

详细描述

Prior to surgery, all patients subject to the study are explained and informed of the prior consent form of prior consent is delivered. During surgery, video recording is performed to check the type of surgical instrument, the time of use, and the event that occurred during surgery. After surgery, the morbidity after surgery will be monitored and recorded. Additional morbidity will be recorded one to three months after surgery.

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

入选标准

  • Patients with gastric cancer shcedulled 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

  • Surgical outcome: pain score(1 month after surgery)
  • Surgical outcome: serum CRP(mg/L)(1 month after surgery)
  • Surgical outcome: bleeding(ml)(1 month after surgery)
  • Surgical outcome: serum Lipase(U/L)(1 month after surgery)
  • Surgical outcome: Drain Lipase(U/L)(1 month after surgery)
  • Duration of use for each surgical instruments(during the operation)
  • Surgical outcome: Drain Amylase(U/L)(1 month after surgery)
  • Surgical outcome: hospital stay(day)(1 month after surgery)
  • Surgical outcome: readmission rate(%)(1 month after surgery)
  • Surgical outcome: serum Amylase(U/L)(1 month after surgery)
  • Surgical outcome: operative time(min)(1 month after surgery)
  • number of use for each surgical instruments(during the operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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