Spontaneous PneumothoraxNCT04758143
Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study
An observational study of Spontaneous Pneumothorax and Recurrence, run by Yuka Kadomatsu at 1 site in Japan.
Trial summary
To investigate the most preventable option to reduce primary spontaneous postoperative recurrence. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Spontaneous Pneumothorax, Recurrence, Surgery
- How many people
- 450 participants
- Where
- 1 siteJapan
- Study dates
- 11 Aug 2020to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Men and Women Who Undergo Pneumothorax Surgery for the First Time at the Age of 16 to 40 Years
Who may be able to join
- 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.
Who cannot join
- History of ipsilateral chest surgery.
- Patients who only underwent exploratory surgery.
- Patients who are judged ineligible by the investigator and the attending surgeon.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Thoracic Surgery, Nagoya University Graduate School of Medicine
Nagoya, 466-8550
Yuka Kadomatsu, MD, +81-52-744-2375, ykadomatsu@med.nagoya-u.ac.jp
Toyofumi Chen-Yoshikawa, PhD, +81-52-744-2375, tyoshikawa@med.nagoya-u.ac.jp
About this study
To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.
Read the 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.
- Conditions
- Spontaneous Pneumothorax, Recurrence, Surgery
- Medical subject headings
- Pneumothorax, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of pneumothorax
Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery
Measured: within 2 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start11 Aug 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spontaneous PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuka Kadomatsu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuka Kadomatsu, Nagoya University
- Investigators
- Toyofumi Chen-Yoshikawa, PhD, Study director, Department of Thoracic Surgery, Nagoya University Graduate Scho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758143
- Sponsor's protocol ID
- 2020-0164 20274
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34930734
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04758143
- Acronym / sponsor ID
- 2020-0164 20274
- Conditions
- Spontaneous Pneumothorax, Recurrence, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Yuka KadomatsuUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Men and Women Who Undergo Pneumothorax Surgery for the First Time at the Age of 16 to 40 Years
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- History of ipsilateral chest surgery.
- Patients who only underwent exploratory surgery.
- Patients who are judged ineligible by the investigator and the attending surgeon.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence rate of pneumothorax
Time frame: within 2 years after the surgery
Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 34930734Kadomatsu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toyofumi Chen-Yoshikawa, PhD study director
Department of Thoracic Surgery, Nagoya University Graduate Scho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Pneumothorax and Recurrence, run by Yuka Kadomatsu at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuka Kadomatsu, MD (+81-52-744-2375, ykadoamtsu@med.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of pneumothorax (time frame: within 2 years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04758143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.