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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003225
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Genitourinary surgery, Hokkaido University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003903

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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