UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027955
Receipt number R000032025
Scientific Title Comparison of 1- day and 2-days prophylactic antimicrobial administration for inhibiting surgical site infection (SSI) in Holmium Laser Enucleation of the prostate (HoLEP).
Date of disclosure of the study information 2017/07/01
Last modified on 2019/12/30 09:50:25

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Basic information

Public title

Comparison of 1- day and 2-days prophylactic antimicrobial administration for inhibiting surgical site infection (SSI) in Holmium Laser Enucleation of the prostate (HoLEP).

Acronym

Comparison of 1- day and 2-days prophylactic antimicrobial administration for inhibiting SSI
in HoLEP.

Scientific Title

Comparison of 1- day and 2-days prophylactic antimicrobial administration for inhibiting surgical site infection (SSI) in Holmium Laser Enucleation of the prostate (HoLEP).

Scientific Title:Acronym

Comparison of 1- day and 2-days prophylactic antimicrobial administration for inhibiting SSI
in HoLEP.

Region

Japan


Condition

Condition

Benign prostate hyperplasia

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To Compare the SSI rate of 1-day and 2-days prophylactic antimicrobial administration in HoLEP

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of SSI occurence

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1-day cefazoin i.v. every 12 hours

Interventions/Control_2

2-days cefazoin i.v. every 12 hours

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

Key inclusion criteria

Those patients who undergo HoLEP

Key exclusion criteria

Those patients who do not agree with this study as a participant.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Masato
Middle name
Last name Fujisawa

Organization

Kobe University

Division name

Urology

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-6155

Email

masato@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Katsumi
Middle name
Last name Shigemura

Organization

Kobe University

Division name

Urology

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-6155

Homepage URL


Email

katsumi@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe Univerity

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB, Kobe University School of Medicine

Address

7-5-1 kusunoki-cho, Chuo-ku, Kobe

Tel

0783825111

Email

kainyu@med.kobe-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

2017 Year 07 Month 01 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 06 Month 27 Day

Date of IRB

2018 Year 05 Month 24 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2021 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 27 Day

Last modified on

2019 Year 12 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032025


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name