UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024205 |
|---|---|
| Receipt number | 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 17:51:58 |
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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
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
takehisa@ise.jrc.or.jp
Sponsor or person
Institute
Ise redcross hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027865
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
