UMIN-CTR Clinical Trial

Basic information
Public title	Study of perioperative infection prevention drug protocol in transurethral prostate enucleation (HoLEP / TUEB):multi-center study
Acronym	Randomized study to determine optimal dosing period of antibiotics for prophylaxis in HoLEP/TUEB
Scientific Title	Study of perioperative infection prevention drug protocol in transurethral prostate enucleation (HoLEP / TUEB):multi-center study
Scientific Title:Acronym	Randomized study to determine optimal dosing period of antibiotics for prophylaxis in HoLEP/TUEB
Region	Japan

Condition
Condition	Benign prostatic hypertrophy
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study of perioperative infection prevention drug protocol
Basic objectives2	Others
Basic objectives -Others	Randomized study to determine optimal dosing period of antibiotics for prophylaxis in in HoLEP / TUEB
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of febrile complications of postoperative within 30 days after the surgery
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
Key inclusion criteria	patients performed HoLEP/TUEB for benign prostatic hypertrophy
Key exclusion criteria	excluding patients: underwent cystolithotripsy or underwent prostate biopsy simultaneously with preoperative pyuria indwelling urethral catheter
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshikazu Togo
Organization	Hyogo College of Medicine
Division name	Department of Urology
Zip code
Address	1-1 Mukogawacho, Nishinomiya, Hyogo
TEL	0798-45-6366
Email	ytogo@hyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshikazu Togo
Organization	Hyogo College of Medicine
Division name	Department of Urology
Zip code
Address	1-1 Mukogawacho, Nishinomiya, Hyogo
TEL	0798-45-6366
Homepage URL
Email	ytogo@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	none
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	兵庫医科大学病院(兵庫県)含む日本UTI共同研究会参加施設およびその関連施設

Other administrative information
Date of disclosure of the study information	2015 Year 01 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	2015 Year 01 Month 01 Day
Date of IRB	2014 Year 12 Month 02 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 30 Day
Date trial data considered complete	2020 Year 01 Month 30 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	We investigate feblile complication within 30 days after surgery.

Management information
Registered date	2014 Year 12 Month 22 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018637