UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese Study of Bidirectional Evaluation of Surgical Performance on Cardiovascular Surgery-0
Title of the study (Brief title)	jBLADE-0 Study
Region	Japan

Condition
Condition	Diseases treated by Cardiovascular Surgery
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this pilot study was to establish the standardized metrics to evaluate the technical skills of board eligible cardiovascular surgery residents performing basic cardiovascular surgical procedures including opening the chest, establishment of cardiopulmonary bypass, harvest of saphenous vein grafts, harvest of internal thoracic arteries, and closing the chest.
Basic objectives2	Others
Basic objectives -Others	Validation of evaluation system
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Validation of standardized metrics determined by external evaluation committee
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Residents who is eligible for Japanese Cardiovascular Surgery Board Certification 2) Board Certified Cardiovascular Surgeons before first re-cirtification
Key exclusion criteria	Eligible surgeons who denied participating this study
Target sample size	155

Research contact person
Name of lead principal investigator	Kazuhiro Hashimoto
Organization	The Jikei University School of Medicine
Division name	Department of Cardiac Surgery
Address	3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Email	kaz-hashi@jikei.ac.jp

Public contact
Name of contact person	Kazuhiro Hashimoto
Organization	The Jikei University School of Medicine
Division name	Department of Cardiac Surgery
Address	3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Homepage URL
Email	kaz-hashi@jikei.ac.jp

Sponsor
Institute	jBLADE study group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	jCUTE
Organization
Division
Category of Funding Organization	Non profit foundation
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	2016 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 11 Month 27 Day
Anticipated trial start date	2016 Year 06 Month 06 Day
Last follow-up date	2017 Year 03 Month 31 Day
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	preinitiation

Management information
Registered date	2016 Year 05 Month 31 Day
Last modified on	2016 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025971