UMIN-CTR Clinical Trial

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 Middle name Last name Masato Fujisawa
Organization	Kobe University
Division name	Urology
Zip code
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 Middle name Last name Katsumi Shigemura
Organization	Kobe University
Division name	Urology
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL	078-382-6155
Homepage URL
Email	katsumi@med.kobe-u.ac.jp

Sponsor
Institute	Kobe Univerity
Institute
Department

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
Address
Tel
Email

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	Open public recruiting
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 07 Month 01 Day

Link to view the page
URL(English)	https://upload.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

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