跳至主要内容
临床试验/NCT04758143
NCT04758143招募中不适用

Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study

Yuka Kadomatsu1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2020年8月11日最近更新:
适应症

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

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

发起方
Yuka Kadomatsu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yuka Kadomatsu

Subinvestigator

Nagoya University

研究点 (1)

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