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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010622
Receipt No. R000012421
Scientific Title Safety and effectiveness of robotic-assisted laparoscopic radical cystectomy
Date of disclosure of the study information 2013/05/01
Last modified on 2013/04/30

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Basic information
Public title Safety and effectiveness of robotic-assisted laparoscopic radical cystectomy
Acronym Robotic-assisted laparoscopic radical cystectomy.
Scientific Title Safety and effectiveness of robotic-assisted laparoscopic radical cystectomy
Scientific Title:Acronym Robotic-assisted laparoscopic radical cystectomy.
Region
Japan

Condition
Condition Bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safty of robotic-assisted laparoscopic radical cystectomy in patients with invasive bladder cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Over all survival rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Robotic-assisted laparoscopin radical cystectomy
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with muscle-invasive bladder cancer.
No evidence of distant metastasis.
Age 20 years old or more, and less than 80 years old.
Patients who wish to come into compliance with protocol.
Each patient voluntarily gave written informed consent before treatment.
Key exclusion criteria Patients with active malignant disease.
Patients who is or may be pregnant.
Patients who is breast feeding at the time of treatment.
Patients who are not suitable for laparoscopic surgery.
Patients who are not considered for being eligible to this trial by investigator.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanayama Hiro-omi
Organization tokushima university
Division name Department of Urology
Zip code
Address 3-18-15 Kuramoto-cho Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization tokushima university
Division name Department of Urology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute tokushima university
Institute
Department

Funding Source
Organization Department of Urology tokushima university
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
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
2013 Year 05 Month 01 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
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 Preinitiation
Date of protocol fixation
2013 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 30 Day
Last modified on
2013 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012421

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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