UMIN-CTR Clinical Trial

Basic information
Public title	The significance of preoperative antimicrobial treatment in patients undergoing ureteroscopy with positive urine culture
Acronym	The significance of preoperative antimicrobial treatment in patients undergoing ureteroscopy with positive urine culture
Scientific Title	The significance of preoperative antimicrobial treatment in patients undergoing ureteroscopy with positive urine culture
Scientific Title:Acronym	The significance of preoperative antimicrobial treatment in patients undergoing ureteroscopy with positive urine culture
Region	Japan

Condition
Condition	urolithiasis
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of preoperative antimicrobial treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intraoperative urine culture The rate of adverse event, especially fever and sepsis after ureteroscopy
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	Patients who underwent ureteroscopy in our center since 2019 April were included.
Key exclusion criteria	We excluded patients who underwent continuous multiple ureteroscopy.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ryoji Middle name Last name Takazawa
Organization	Tokyo Metropolitan Ohtsuka hospital
Division name	Division of urology
Zip code	170-8476
Address	Minami-ohtsuka 2-8-1, Toshima-ku, Tokyo, Japan
TEL	03-3941-3211
Email	ryoji_takazawa@tmhp.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Kobayashi
Organization	Tokyo Metropolitan Ohtsuka hospital
Division name	Division of urology
Zip code	170-8476
Address	Minami-ohtsuka 2-8-1, Toshima-ku, Tokyo, Japan
TEL	03-3941-3211
Homepage URL
Email	angel_sapporo_0329@yahoo.co.jp

Sponsor
Institute	Tokyo Metropolitan Ohtsuka hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Ohtsuka hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Metropolitan Ohtsuka hospital
Address	Minami-ohtsuka 2-8-1, Toshima-ku, Tokyo, Japan
Tel	03-3941-3211
Email	angel_sapporo_0329@yahoo.co.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	2019 Year 08 Month 26 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	120
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	2019 Year 03 Month 01 Day
Date of IRB	2019 Year 08 Month 16 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2021 Year 02 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No extra information

Management information
Registered date	2019 Year 08 Month 26 Day
Last modified on	2021 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043112