UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical differences between men and women undergoing surgery for acute type A aortic dissection.
Title of the study (Brief title)	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	Tomoaki Suzuki
Organization	Shiga university of medial science
Division name	department of cardiovascular surgery
Address	setatukinowa, otsu city
TEL	077-548-2241
Email	suzukit@belle.shiga-med.ac.jp

Public contact
Name of contact person	Tomoaki Suzuki
Organization	Shiga university of medial science
Division name	department of cardiovascular surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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