UMIN-CTR Clinical Trial

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
Last 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
1st 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