UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050764 |
|---|---|
| Receipt number | R000057847 |
| Scientific Title | Risk factors for PGS after thoracic aortic surgery |
| Date of disclosure of the study information | 2023/04/04 |
| Last modified on | 2023/04/04 18:49:59 |
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Basic information
Public title
Perigraft seroma after thoracic aortic surgery
Acronym
PGS after thoracic aortic surgery
Scientific Title
Risk factors for PGS after thoracic aortic surgery
Scientific Title:Acronym
Risk factors for PGS after thoracic aortic surger
Region
| Japan |
Condition
Condition
Thoracic aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated pertinent factors associated with mediastinal perigraft seroma (PGS) after thoracic aortic surgery.
Basic objectives2
Others
Basic objectives -Others
In addition, we provided a clinical review of this entity, as a review article with abundant mediastinal PGS cases is rare.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pertinent factors associated with mediastinal perigraft seroma formation following thoracic aortic surgery
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent either ascending aortic replacement or aortic arch replacement between 2016 and 2022 in our institution were enrolled in the present study. Fluid capsules with a diameter greater than 3.0 cm and radiodensity less than 25 Housefield units were screened to detect PGS on follow-up using computed tomography scans postoperatively. Patients requiring emergency surgery, using an elephant trunk, or redo surgery were included in this study.
Key exclusion criteria
Patients who developed deep sternal infection or PGS immediately after initial surgery (within 2 months) were excluded from the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Suzuki |
Organization
Shinmatsudo Central General Hospital
Division name
Cardiovascular Surgery
Zip code
270-0034
Address
1-380 Shinmatsudo Matsudo Chiba, Japan
TEL
047-345-1111
m07201079@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Suzuki |
Organization
Saitama Sekishinnkai Hospital
Division name
Cardiovascular Surgery
Zip code
350-1305
Address
2-37-20 Iruma river Sayama city, Saitama prefecture
TEL
0429536611
Homepage URL
ryosuzuki0722@yahoo.co.jp
Sponsor or person
Institute
Shinmatsudo Central General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinmatsudo Central General Hospital
Address
1-380 Shinmatsudo Matsudo Chiba, Japan
Tel
047-345-1111
ryosuzuki0722@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The incidence rate of PGS was 14.6 percent. The average radiodensity of the mass was 16.6 HU. The average onset of PGS was 8.5 months after surgery. Multivariate logistic regression analysis revealed that ejection fraction (OR: 1.25, CI: 1.03 1.50, P 0.021), aortic dissection (versus degenerative aortic aneurysm) (OR: 6.61, CI: 1.35 32.4, P 0.02), and warfarin use (OR: 6.67, CI: 1.19 37.1, P 0.03) significantly contributed to mediastinal PGS after thoracic aortic surgery.
Management information
Registered date
| 2023 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057847
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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