UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016030 |
|---|---|
| Receipt number | R000018637 |
| Scientific Title | Study of perioperative infection prevention drug protocol in transurethral prostate enucleation (HoLEP / TUEB):multi-center study |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2020/03/17 14:11:07 |
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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
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
ytogo@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018637
