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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024205
Receipt No. R000027865
Scientific Title The benefit of short time continuous saline bladder irrigation after transurethral resection for the treatment of non-muscle invasive bladder cancer
Date of disclosure of the study information 2016/09/29
Last modified on 2021/10/04

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Basic information
Public title The benefit of short time continuous saline bladder irrigation after transurethral resection for the treatment of non-muscle invasive bladder cancer
Acronym The benefit of short time irrigation
Scientific Title The benefit of short time continuous saline bladder irrigation after transurethral resection for the treatment of non-muscle invasive bladder cancer
Scientific Title:Acronym The benefit of short time irrigation
Region
Japan

Condition
Condition non muscle invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of short time continuous saline bladder irrigation (s-CSBI) after transurethral resection of bladder tumor (TURBT) in patients with non-muscle invasive bladder cancer (NMIBC)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes recurrence free survival
Key secondary outcomes adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 3hours CSBI after TURB
Interventions/Control_2 15hours CSBI after TURB
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 and Female
Key inclusion criteria primary non muscle invasive bladder cancer(Low and intermediate risk)
Key exclusion criteria upper urinary tract cancer
muscle invasive bladder cancer
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takehisa
Middle name
Last name Onishi
Organization Ise re cross hospital
Division name Urology
Zip code 516-8512
Address Hunae1-471-2, Ise,MIe
TEL 0596-28-2171
Email takehisa@ise.jrc.or.jp

Public contact
Name of contact person
1st name Takehisa
Middle name
Last name Onishi
Organization Ise re cross hospital
Division name Urology
Zip code 516-8512
Address Hunae1-471-2, Ise,MIe
TEL 0596-28-2171
Homepage URL
Email takehisa@ise.jrc.or.jp

Sponsor
Institute Ise redcross hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ise redcross hospital
Address Hunae Ise Mie
Tel 0596-28-2171
Email takehisa@ise.jrc.or.jp

Secondary IDs
Secondary IDs YES
Study ID_1 28-1
Org. issuing International ID_1 Ise redcross hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 29 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 240
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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
2016 Year 09 Month 01 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 28 Day
Last modified on
2021 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027865

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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