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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029179
Receipt No. 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

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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
Email 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
Email suzukit@belle.shiga-med.ac.jp

Sponsor
Institute Shiga university of medial science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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