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临床试验/NCT04831554
NCT04831554Unknown不适用

Comparison of the Efficacy of Single Tube Versus Multiple Tubes Drainage After Bullectomy and Pleurodesis for Primary Spontaneous Pneumothorax

Peking University Third Hospital0 个研究点目标入组 200 人开始时间: 2021年10月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
recurrence

研究概览

简要总结

There was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis. After routine procedure the participants will randomized to either placed single chest tube or multiple chest tubes

详细描述

Primary spontaneous pneumothorax (PSP) occurs after the rupture of small bullae or a subpleural bleb in otherwise normal lungs. The indications for surgical treatment include persistent air leak after intercostal tube drainage, recurrent PSP, and contralateral PSP. The video-assisted thoracoscopic surgery (VATS) approach probably represents the treatment of choice for PSP.

The presence of a residual pleural space after surgery may be a factor associated with increased risk of recurrence. One possible hypothesis to explain the association between residual pleural space and recurrence of pneumothorax may be the failed pleurodesis due to lack of pleura-pleura apposition. Multiple chest tubes are effective in clinical practice, but there was no convinctive evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis. This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis.After routine procedure the participants will randomized to either placed multiple chest tubes or single chest tube.

The recurrence of the two group and other postoperative clinical parameters will be observed.

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed by chest radiograph or CT as primary spontaneous pneumothorax
  • Underwent bullectomy and pleurodesis
  • Postoperative indwelling chest tubes

排除标准

  • Secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax
  • Previous surgery history
  • People with severe comorbidities

结局指标

主要结局

recurrence

时间窗: 2 years after operation

Recurrence of pneumothorax during 2 years follow-up

次要结局

  • complications(30days after operation)

研究者

申办方类型
Other
责任方
Sponsor

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