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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017135
Receipt No. R000019867
Scientific Title Efficacy of Goreisan in transurethral resection of prostate
Date of disclosure of the study information 2015/04/14
Last modified on 2019/05/14

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Basic information
Public title Efficacy of Goreisan in transurethral resection of prostate
Acronym RCT of Goreisan
Scientific Title Efficacy of Goreisan in transurethral resection of prostate
Scientific Title:Acronym RCT of Goreisan
Region
Japan

Condition
Condition Patients who undergo transurethral resection of prostate because of benign prostatic hypertrophy
Classification by specialty
Urology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to determine the efficacy of Goreisan in transurethra resection of prostate
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes change of serum potassium levels and occurrence of TUR syndrome
Key secondary outcomes 1) perioperative mortality
2) neurological and circuratory abnormality
3) serum creatinine levels
4) lactate levels

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 intake of Goreisan as a preoperative medication
Interventions/Control_2 no intake of Goreisan as conventional treatment
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male
Key inclusion criteria 1) Benign prostatic hypertrophy
2) male: 20-89 year-old
3) patients showed consent of this study
Key exclusion criteria 1) emergency operation
2) simultaneously having different operation
3) serum potassium level <125mmol/l
4) having severe coronary diseases and cerebral vessel diseases
5) having severe liver dysfunctions
6) hyperkalemia
7) hemodialysis
8) permanent pacemaker
9) medication of CYP3A4 inhibitors
10) medication of vasopression related drugs
11) medication of inotropic agents
12) medication of Potassium-sparing diuretics
13) BMI>or=35
14) Coagulation disorder
15) Severe complication with a diagnosis of 6 months remaining
16) Participation in other intervention studies
17) being judged as not appropriate for this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Department of Anesthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL 072-683-1221
Email ane022@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Nakahira
Organization Osaka Medical College
Division name Department of Anesthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL 72-683-1221
Homepage URL
Email ane052@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Kosaka-Rinsyomasui fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Sanko Hoapital (in Takatsuki, Osaka)
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 大阪医科大学 (大阪府), 健栄会三康病院

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 14 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 04 Month 14 Day
Date of IRB
2015 Year 05 Month 11 Day
Anticipated trial start date
2015 Year 05 Month 12 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 10 Month 01 Day
Date analysis concluded
2018 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 14 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019867

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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