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临床试验/NCT03743389
NCT03743389Unknown不适用

Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes

Tongji Hospital0 个研究点目标入组 80 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
total drainage volume

研究概览

简要总结

Pigtail catheter(PC) has been used for thoracic drainage in the patients with pneumothorax or traumatic hemothorax/hemopneumothorax, and some study indicated that PC could obtain similar outcomes when comparing with chest tube(CT). Although PC could drain air and fluid out from pleural cavity and also help pulmonary re-expanding, rare reports are available to thoracic post-operative management. Uniportal video-assisted thoracoscopic surgery(VATS) has been widely applied in many medical center in recent years, most of mediastinal nodes could be resected under uniportal-VATS. This study aims to further study the application of 12G PC during post-operative management and comparing the validity and safety between PC(12G) and CT(16F) after uniportal-VATS for mediastinal nodes resection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Between 18 and 80 years of age.
  • Diagnosed with potentially resectable mediastinal mass.
  • With indication for uniportal-VATS.
  • For whom informed consent will be obtained before the study.

排除标准

  • Previous thoracic surgery at the same side.
  • Have to receive open surgery although uniportal-VATS is planned.
  • Refuse to sigh the consent

结局指标

主要结局

total drainage volume

时间窗: 1 month

tube duration

时间窗: 1 month

次要结局

  • infection rate of incision(1 month)
  • post-operative pain(3 days after operation)
  • rate of subcutaneous emphysema(1 month)
  • length of hospital stay after surgery(1 month)
  • satisfaction of the incision after healing(1 month)
  • rate of chest tube re-insertion or thoracocentesis(1 month)

研究者

申办方类型
Other
责任方
Sponsor

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