Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study
1 other identifier
observational
450
1 country
1
Brief Summary
To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2020
CompletedFirst Submitted
Initial submission to the registry
February 15, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedFebruary 18, 2021
February 1, 2021
1.6 years
February 15, 2021
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence rate of pneumothorax
Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery
within 2 years after the surgery
Eligibility Criteria
Men and Women Who Undergo Pneumothorax Surgery for the First Time at the Age of 16 to 40 Years
You may qualify if:
- 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.
You may not qualify if:
- History of ipsilateral chest surgery.
- Patients who only underwent exploratory surgery.
- Patients who are judged ineligible by the investigator and the attending surgeon.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuka Kadomatsulead
Study Sites (1)
Department of Thoracic Surgery, Nagoya University Graduate School of Medicine
Nagoya, 466-8550, Japan
Related Publications (1)
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.
PMID: 34930734DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toyofumi Chen-Yoshikawa, PhD
Department of Thoracic Surgery, Nagoya University Graduate Scho
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Subinvestigator
Study Record Dates
First Submitted
February 15, 2021
First Posted
February 17, 2021
Study Start
August 11, 2020
Primary Completion
March 31, 2022
Study Completion
March 31, 2025
Last Updated
February 18, 2021
Record last verified: 2021-02