UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047975
Receipt number R000054620
Scientific Title Survey of perioperative complication in patients taking hormone replacement therapy or selective estrogen receptor modulator
Date of disclosure of the study information 2022/06/08
Last modified on 2024/09/20 11:34:51

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Basic information

Public title

Survey of perioperative complication in patients taking hormone replacement therapy or selective estrogen receptor modulator

Acronym

Perioperative complication and low dose of estrogen and progestin

Scientific Title

Survey of perioperative complication in patients taking hormone replacement therapy or selective estrogen receptor modulator

Scientific Title:Acronym

Perioperative complication and low dose of estrogen and progestin

Region

Japan


Condition

Condition

Surgical patients taking hormone replacement therapy or selective estrogen receptor modulator

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Survey of thrombosis during perioperative period

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Thrombosis during perioperative period

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

40 years-old <=

Age-upper limit

100 years-old >

Gender

Female

Key inclusion criteria

Patients taking hormone replacement therapy or selective estrogen receptor modulator

Key exclusion criteria

None

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yukio
Middle name
Last name Hayashi

Organization

Yoka Municipal Hospital

Division name

Anesthesiology

Zip code

6678555

Address

1878-1 Yoka, Yoka-cho, Yabu, 667-8555 Hyogo, JAPAN

TEL

0796625555

Email

yhayashi@anes.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Yukio
Middle name
Last name Hayashi

Organization

Yoka Municipal Hospital

Division name

Anesthesiology

Zip code

6678555

Address

1878-1 Yoka, Yoka-cho, Yabu, 667-8555 Hyogo, JAPAN

TEL

0796625555

Homepage URL


Email

yhayashi@anes.med.osaka-u.ac.jp


Sponsor or person

Institute

Yoka Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Yoka Municipal Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

None


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB, Yoka Municipal Hospital

Address

1878-1 Yoka, Yoka-cho, Yabu, 667-8555 Hyogo, JAPAN

Tel

0796625555

Email

somu1@hosp.yoka.hyogo.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

2022 Year 06 Month 08 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

No longer recruiting

Date of protocol fixation

2022 Year 05 Month 15 Day

Date of IRB

2022 Year 06 Month 01 Day

Anticipated trial start date

2022 Year 06 Month 07 Day

Last follow-up date

2023 Year 12 Month 16 Day

Date of closure to data entry

2023 Year 12 Month 30 Day

Date trial data considered complete

2023 Year 12 Month 30 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information

We examined the incidence of surgical patients who take selective estrogen receptor modulators.


Management information

Registered date

2022 Year 06 Month 07 Day

Last modified on

2024 Year 09 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054620