Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax
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
- 否
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
Sanghoon Jheon
Chief, Department of Thoracic and Cardiovascular Surgery
Seoul National University Bundang Hospital
