UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040886 |
|---|---|
| Receipt number | R000046482 |
| Scientific Title | Most Preventable surgical option to reduce primary spontaneous pneumothorax patients postoperative recurrence: A prospective cohort study |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2024/06/26 10:26:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Most Preventable surgical option to reduce primary spontaneous pneumothorax patients postoperative recurrence: A prospective cohort study
Acronym
PATCH Study
Scientific Title
Most Preventable surgical option to reduce primary spontaneous pneumothorax patients postoperative recurrence: A prospective cohort study
Scientific Title:Acronym
PATCH Study
Region
| Japan |
Condition
Condition
Primary spontaneous pneumothorax
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery
Key secondary outcomes
Complication rates, surgical duration, blood loss, reoperation rate for recurrent pneumothorax
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who have spontaneous pneumotho rax diagnosed by radiography and plan to und erwent initial VATS bullectomy.
2)Patients who receive informed consent to at tend this study, and the agreements are provi ded in a document.
The consent of parents are also required, in ca se patients are under 20-years old.
Key exclusion criteria
1)History of ipsilateral chest surgery.
2)Patients who only underwent exploratory surgery.
3)Patients who are judged ineligible by the in vestigator and the attending surgeon.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Chen |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nagoya University Graduate School of Medicin e
Division name
Department of Thoracic Surgery
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-855 0, Japan
TEL
052-744-2375
tyoshikawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Kadomatsu |
Organization
Nagoya University Graduate School of Medicin e
Division name
Department of Thoracic Surgery
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-855 0, Japan
TEL
052-744-2375
Homepage URL
ykadomatsu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Nagoya Univ ersity Graduate School of Medicine, Nagoya, J apan
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Surgery, Nagoya Univ ersity Graduate School of Medicine, Nagoya, J apan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital Institutional review board
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-855 0, Japan
Tel
052-744-1958
center@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study protocol is going to be approved at each institution.
Management information
Registered date
| 2020 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046482
