Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence After Operation by Video-assisted Thoracic Surgery in the Treatment of Primary Spontaneous Pneumothorax(PSP)
试验速览
- 阶段
- 3 期
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- recurrence rate
研究概览
简要总结
This subject analysis of the influence of the dissociating inferior pulmonary ligament on pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by video assisted thoracic surgery. All patients are randomly divided into two groups: group A and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed between the two groups.
详细描述
Wedge resection of the lung is usually used in the treatment of primary spontaneous pneumothorax. And the pleural treatment also might be used. But part of secondary pneumothorax patients who had undergone surgical, the bullae can be found especially in the apical of lung, even if the pleural have been treated in some way.This subject provides a new way of thinking and method to solve the problem of recurrent spontaneous pneumothorax.
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
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients diagnosis pneumothorax with chest radiograph or computed tomography (CT)
- •The clinical and final pathological diagnosis for patient is PSP.
- •The patients with stable vital signs, no contraindication for operation and no communication barriers.
- •The patients,after informed of test content, significance and risk, who voluntarily enroll and sign informed consent.
排除标准
- •The patients who refuse to do a video assisted thoracic surgery.
- •The patients with pneumothorax with specific causes such as pulmonary hamartoangiomyomatosis, catamenial pneumothorax, and pneumothorax secondary to chronic obstructive pulmonary disease.
- •The patients who were older than 50 years
- •The patients with familial history of pneumothorax.
- •The patients with mental disorders, low Intelligence Quotient, can not objectively reflect the indicators of observation.
- •The patients who refuse to follow-up.
结局指标
主要结局
recurrence rate
时间窗: 3 years
the 3- year recurrence rate of pneumothorax after surgery.
次要结局
- pulmonary reexpansion rate(1 day and 4 days)
研究者
Jian Cui
Principal Investigator
Beijing Haidian Hospital