跳至主要内容
临床试验/NCT00615849
NCT00615849已完成3 期

Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax

Seoul National University Bundang Hospital2 个研究点 分布在 2 个国家目标入组 1,440 人开始时间: 2006年11月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,440
试验地点
2
主要终点
recurrence

研究概览

简要总结

For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. According to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. The purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of PSP.

研究设计

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

入排标准

年龄范围
16 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • recurrent pneumothorax
  • bilateral pneumothorax
  • total collapse/tension pneumothorax
  • previous history of contralateral pneumothorax
  • visible bulla on simple X-ray
  • special occupation/situation
  • air leakage more than 2 days with drainage catheter for 1st attack patients

排除标准

  • patient refusal and reoperation case

结局指标

主要结局

recurrence

时间窗: follow up more than 1 year

次要结局

  • complications(follow up more than 1 year)

研究者

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

Sanghoon Jheon

Chief, Department of Thoracic and Cardiovascular Surgery

Seoul National University Bundang Hospital

研究点 (2)

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