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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028640
Receipt No. R000032779
Scientific Title Research of robot assisted laparoscopic radical cystectomy and urinary diversion for bladder cancer
Date of disclosure of the study information 2017/10/02
Last modified on 2017/08/11

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Basic information
Public title Research of robot assisted laparoscopic radical cystectomy and urinary diversion for bladder cancer
Acronym Robot assisted laparoscopic radical cystectomy
Scientific Title Research of robot assisted laparoscopic radical cystectomy and urinary diversion for bladder cancer
Scientific Title:Acronym Robot 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 confirm safty and efficacy of robot assisted laparoscopic radical cystectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of adverse event within 30 post-operative day
Key secondary outcomes Rate of outworking with robot, Rate of open conversion, Operative time, Blood loss, Number of lymphnode yield, Post-operative day of start drinking, Post-operative day of start dieting

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
Device,equipment Maneuver
Interventions/Control_1 Robot assisted laparoscopic 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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Pathological provn bladder cancer
2. Clinical stage T1-4N0-2M0 and candidate for radical cystectomy
3. ECOG performance status 0-1
4. 20-85 years-old
5. Document consent with signature and date by the principal
Key exclusion criteria 1. Active double cancer (excluding urotherial and prostate cancer)
2. Patients who are difficult to undergo surgery or anesthesia
3. GOT or GPT: More than 5 times the reference value upper limit GOT or GPT
4. WBC or RBC or Plt: 30% or less of the reference value lower limit
5. PT or APTT: More than twice the reference value
6. Patient deemed inappropriate by doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Makiyama
Organization Yokohama City University Hospital
Division name Urology
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama city
TEL 045-787-2800
Email makiya@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhide Makiyama
Organization Yokohama City University Hospital
Division name Urology
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama city
TEL 045-787-2800
Homepage URL
Email makiya@yokohama-cu.ac.jp

Sponsor
Institute Department of Urology, Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City 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
2017 Year 10 Month 02 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 02 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
2017 Year 08 Month 11 Day
Last modified on
2017 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032779

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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