Clinical trial NCT04758143: Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study
Official title: Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Pneumothorax
Recurrence
Surgery
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 450
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and Women Who Undergo Pneumothorax Surgery for the First Time at the Age of 16 to 40 Years

Brief summary: To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who have spontaneous pneumothorax diagnosed by radiography and plan to underwent initial VATS bullectomy.
2. 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.

Exclusion Criteria:

1. History of ipsilateral chest surgery.
2. Patients who only underwent exploratory surgery.
3. Patients who are judged ineligible by the investigator and the attending surgeon.

Primary outcomes:
measure: Recurrence rate of pneumothorax
timeFrame: within 2 years after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Department of Thoracic Surgery, Nagoya University Graduate School of Medicine
Study officials:
affiliation: Department of Thoracic Surgery, Nagoya University Graduate Scho
name: Toyofumi Chen-Yoshikawa, PhD
role: STUDY_DIRECTOR
References:
citation: Kadomatsu Y, Yoshioka H, Shigemitsu K, Nomata Y, Mori S, Hijiya K, Motoyama H, Ichikawa Y, Sueyoshi K, Okasaka T, Miyamoto E, Kobayashi M, Takahashi M, Fujinaga T, Takechi H, Yamagishi H, Takuwa T, Kobayashi J, Sakamoto J, Taniguchi T, Hanaoka N, Kubo Y, Chen-Yoshikawa TF. Multicentre, prospective, observational study investigating the most appropriate surgical option that can prevent the recurrence of primary spontaneous pneumothorax after surgery: the PATCH study, protocol. BMJ Open. 2021 Dec 20;11(12):e052045. doi: 10.1136/bmjopen-2021-052045.