Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Recurrence rate of pneumothorax
研究概览
简要总结
To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.
详细描述
Pneumothorax is a disease in which air in the lungs leaks into the pleural cavity. It is a disease that occurs most often in young people with active social activities, and it occurs in about 100,000 people in 14 cases. The recurrence rate is as high as 17% to 54%, and the delay of the rehabilitation by the ambulatory with the treatment and prolongation of the hospitalization becomes a problem. It becomes a large failure for the youth who requires early rehabilitation. According to the latest report from the Japanese Society of Surgery, approximately 12,000 pneumothorax surgeries are performed annually in Japan. Many of them applied absorbent material to the surgical stump (coverage technique). However, there are no prospective studies, and efficacy does not appear adequately tested. It is necessary to accumulate prospective data from multiple centers to investigate the coverage technique's real effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Patients who have spontaneous pneumothorax diagnosed by radiography and plan to underwent initial VATS bullectomy.
- •Patients who receive informed consent to attend this study, and the agreements are provided in a document.
- •The consent of parents is also required, in case patients are under 20-years old.
排除标准
- •History of ipsilateral chest surgery.
- •Patients who only underwent exploratory surgery.
- •Patients who are judged ineligible by the investigator and the attending surgeon.
结局指标
主要结局
Recurrence rate of pneumothorax
时间窗: within 2 years after the surgery
Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery
次要结局
未报告次要终点
研究者
Yuka Kadomatsu
Subinvestigator
Nagoya University
