UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003225 |
|---|---|
| Receipt number | R000003903 |
| Scientific Title | Perioperative complication of radical cytectomy: multi-institutional study |
| Date of disclosure of the study information | 2010/02/22 |
| Last modified on | 2015/03/24 14:39:29 |
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Basic information
Public title
Perioperative complication of radical cytectomy: multi-institutional study
Acronym
Complication of radical cystectomy
Scientific Title
Perioperative complication of radical cytectomy: multi-institutional study
Scientific Title:Acronym
Complication of radical cystectomy
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine perioperative death rate as well as complication rate in radical cytectomy in Japanese patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
perioparative death rate
complication rate
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 undergoing radical cystectomy
Key exclusion criteria
Patients with incomplete data.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashige Abe |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Genitourinary Surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Genitourinary surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Genitourinary surgery, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2009 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are collecting date regarding perioperative events from our teaching hospitals in order to determine perioperative death rate as well as characteristics of complication in Japanese patients.
Management information
Registered date
| 2010 | Year | 02 | Month | 21 | Day |
Last modified on
| 2015 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003903
