UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022228
Receipt number R000025602
Scientific Title Is it necessary to perform syphilis test before operation?
Date of disclosure of the study information 2016/05/06
Last modified on 2019/05/09 14:20:33

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Basic information

Public title

Is it necessary to perform syphilis test before operation?

Acronym

Is it necessary to perform syphilis test before operation?

Scientific Title

Is it necessary to perform syphilis test before operation?

Scientific Title:Acronym

Is it necessary to perform syphilis test before operation?

Region

Japan


Condition

Condition

surgery cases

Classification by specialty

Surgery in general Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The necessary of syphilis test before surgery

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

positive rate of syphilis test

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

surgery cases

Key exclusion criteria

none

Target sample size

60000


Research contact person

Name of lead principal investigator

1st name Hironobu
Middle name
Last name Ueshima

Organization

Showa University Hospital

Division name

Anesthesiology

Zip code

142-8666

Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyogawa

TEL

03-3784-8575

Email

ueshimhi@yahoo.co.jp


Public contact

Name of contact person

1st name Hironobu
Middle name
Last name Ueshima

Organization

Showa University Hospital

Division name

Anesthesiology

Zip code

142-8666

Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyogawa

TEL

03-3784-8575

Homepage URL


Email

ueshimhi@yahoo.co.jp


Sponsor or person

Institute

Showa University Hospital

Institute

Department

Personal name



Funding Source

Organization

Showa University Hospital

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

Showa univerity hospital

Address

1-5-8, hatanodai, shinagawa-ku, tokyo

Tel

03-3784-8575

Email

ueshimhi@med.showa-u.ac.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

2016 Year 05 Month 06 Day


Related information

URL releasing protocol

file:///Users/UESHIMAHIRONOBU/protocol.htm

Publication of results

Unpublished


Result

URL related to results and publications

file:///Users/UESHIMAHIRONOBU/Downloads/kataoka.htm

Number of participants that the trial has enrolled

63139

Results

There are no significance between each group.

Results date posted

2019 Year 05 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

On the preoperative examination, syphilis examination has been performed.

Participant flow

63139 patients in showa university hospital was investigated.

Adverse events

None

Outcome measures

With or without of syphilis examination

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 05 Month 06 Day

Date of IRB

2016 Year 05 Month 06 Day

Anticipated trial start date

2016 Year 05 Month 06 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Positive rate of Syphilis testing between 2013 and 2015.


Management information

Registered date

2016 Year 05 Month 06 Day

Last modified on

2019 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025602


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name