UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037807 |
|---|---|
| Receipt number | R000043112 |
| Scientific Title | The significance of preoperative antimicrobial treatment in patients undergoing ureteroscopy with positive urine culture |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2021/02/25 22:09:40 |
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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
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
angel_sapporo_0329@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Ohtsuka hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043112
