NCT01463553Unknown4 期
Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Recurrence of Primary Spontaneous Pneumothorax (PSP)
研究概览
简要总结
The purpose of this study is to:
- Evaluate the validity of using abnormal characteristics of the pneumothorax line, as evaluated from chest X-ray film, as the operative indications for video-assisted thoracic surgery (VATS) on primary spontaneous pneumothorax (PSP).
- Through a randomized double blind controlled trial on patients whose PSP was caused by lung bullae, evaluate the effectiveness of pleurodesis in terms of the rate of recurrence of PSP and the trauma of the operation on patients.
- Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in whom obvious bullous forms are seen in PSP pneumothorax lines, or whose pneumothorax lines are rough and interrupted with or without thoracentesis, thoracic close drainage
- •patients whose lung compression exceeded 30% for the first incidence of pneumothorax
- •patients between the ages of 14 and 40, with normal vital signs (body temperature, breathing, blood pressure, pulse) and normal results on routine examination (routine blood test, liver and kidney functions)
- •no language barrier, such as surdimutism, aphasia
- •patients who voluntarily joined the group and signed the informed consent after reviewing the substance, significance and risks of this experiment
排除标准
- •patients who refuse VATS operation
- •patients who refuse the follow-up
- •patients with secondary spontaneous pneumothorax including that caused by emphysema, COPD, asthma, pulmonary lymphangiomyomatosis, thoracic injury and other diseases
- •patients with mental illness, low IQ, or inability to understand the informed consent
- •substance abusers
研究组 & 干预措施
wedge resection
No Intervention
Wedge resection and pleurodosis
Experimental
干预措施: VATS pleurodesis (Procedure)
结局指标
主要结局
Recurrence of Primary Spontaneous Pneumothorax (PSP)
时间窗: 24 months
Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax
次要结局
- Did not recurrence(24months)
研究者
Huang Yuqing
Deputy Director
Beijing Haidian Hospital
研究点 (1)
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