UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008267 |
|---|---|
| Receipt number | R000009745 |
| Scientific Title | Prospective study of complications and mortality after radical cystectomy |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2017/06/30 16:37:02 |
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Basic information
Public title
Prospective study of complications and mortality after radical cystectomy
Acronym
Prospective study of complications and mortality after radical cystectomy
Scientific Title
Prospective study of complications and mortality after radical cystectomy
Scientific Title:Acronym
Prospective study of complications and mortality after radical cystectomy
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We prospectively evaluate early postoperative complications and mortality after radical cystectomy using a standardized methods.
Basic objectives2
Others
Basic objectives -Others
We evaluate the safety of radical cystectomy.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative complication and mortality after radical cystectomy within 90-day
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 and Female
Key inclusion criteria
Patients scheduled to undergo radical cystectomy
Key exclusion criteria
Patients who had past pelvic surgery and radiation therapy are excluded, and no patients had distant metastatic disease at radical cystectomy.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Masumori |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
Minami-1 Nishi-16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
masumori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Hirobe |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
Minami-1 Nishi-16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
mhirobe@sapmed.ac.jp
Sponsor or person
Institute
Department of Urology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
札幌医科大学付属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2017 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009745
