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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002734
Receipt No. R000003268
Scientific Title Safety and effectiveness of Holmium Laser enucleation of the prostate in patients on ongoing oral antiplatelet therapy
Date of disclosure of the study information 2009/11/10
Last modified on 2009/11/09

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Basic information
Public title Safety and effectiveness of Holmium Laser enucleation of the prostate in patients on ongoing oral antiplatelet therapy
Acronym Safety and effectiveness of Holmium Laser enucleation of the prostate in patients on ongoing oral antiplatelet therapy
Scientific Title Safety and effectiveness of Holmium Laser enucleation of the prostate in patients on ongoing oral antiplatelet therapy
Scientific Title:Acronym Safety and effectiveness of Holmium Laser enucleation of the prostate in patients on ongoing oral antiplatelet therapy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and effectiveness of Holmium Laser enucleation of the prostate in patients on ongoing oral antiplatelet therapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Persitent bleeding required cauterization of bleeders within 7 days after surgery
Key secondary outcomes 1)Blood transfusion
2)Postoperative decrease of Hb
3)IPSS, Qmax, PVR

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Patient on ongoing antiplatelet therapy
Interventions/Control_2 Patient without oral antiplatelet trapy
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 suffering from lower urinary tract symptom secondary to BPH.
Key exclusion criteria 1) Anesthesiologists (ASA) score of 4 or higher
2) Prostate cancer daignosed before HoLEP
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyohiko Watanabe
Organization Okayama University Hospital
Division name Urology
Zip code
Address 2-5-1, Shikata, Okayama
TEL 086-235-7287
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Okayama University Hospital
Division name General office
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Okayama University Hospital
Organization
Division
Category of Funding Organization
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
2009 Year 11 Month 10 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
2009 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 09 Day
Last modified on
2009 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003268

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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