UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029179 |
|---|---|
| Receipt number | R000033358 |
| Scientific Title | Clinical differences between men and women undergoing surgery for acute type A aortic dissection. |
| Date of disclosure of the study information | 2017/09/18 |
| Last modified on | 2017/09/18 11:06:49 |
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Basic information
Public title
Clinical differences between men and women undergoing surgery for acute type A aortic dissection.
Acronym
Gender difference in acute type A dissection
Scientific Title
Clinical differences between men and women undergoing surgery for acute type A aortic dissection.
Scientific Title:Acronym
Gender difference in acute type A dissection
Region
| Japan |
Condition
Condition
acute type A aortic dissection
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The differences in clinical features, surgical outcome, and long-term fate between men and women who undergo surgery for type A aortic dissection are not well known.
Basic objectives2
Others
Basic objectives -Others
There is very little in the literature describing the gender-related differences in patient background and surgical outcome in acute type A aortic dissection. The aim of the present study was to identify gender-related features by comparing the clinical background and surgical outcome of male and female patients who underwent emergent surgery for acute type A aortic dissection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operative mortality
Key secondary outcomes
late reoperation and mortality
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients underwent surgery for acute type A dissection
Key exclusion criteria
not adult patients
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Suzuki |
Organization
Shiga university of medial science
Division name
department of cardiovascular surgery
Zip code
Address
setatukinowa, otsu city
TEL
077-548-2241
suzukit@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Suzuki |
Organization
Shiga university of medial science
Division name
department of cardiovascular surgery
Zip code
Address
setatukinowa, otsu city
TEL
077-548-2241
Homepage URL
suzukit@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga university of medial science
Institute
Department
Personal name
Funding Source
Organization
Shiga university of medial science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 09 | Month | 18 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From January 2004 to December 2016, 303 patients, consisting of 147 females and 156 males, underwent surgery for acute type A aortic dissection at our institution. We compared the patient background and surgical outcome between the two cohorts.
The primary endpoint was operative mortality and the secondary endpoints late mortality and late reoperation. Patients undergo outpatient follow-up through computed tomography about every six to twelve months after hospital discharge.
Management information
Registered date
| 2017 | Year | 09 | Month | 18 | Day |
Last modified on
| 2017 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033358
