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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020755
Receipt No. R000023933
Scientific Title Robot-assisted laparoscopic cystectomy in the bladder cancer treatment
Date of disclosure of the study information 2016/01/28
Last modified on 2018/01/15

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Basic information
Public title Robot-assisted laparoscopic cystectomy in the bladder cancer treatment
Acronym Robot-assisted laparoscopic cystectomy
Scientific Title Robot-assisted laparoscopic cystectomy in the bladder cancer treatment
Scientific Title:Acronym Robot-assisted laparoscopic cystectomy
Region
Japan

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

Objectives
Narrative objectives1 As operation treatment for the bladder cancer, I perform robot-assisted laparoscopic cystectomy and examine the safety and operation outcomes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes operation outcomes(operation time, bleeding, perisurgical complication, surgical margin 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
Device,equipment
Interventions/Control_1 robot-assisted operation
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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Invasive bladder cancer without the distant metastasis. If it is only regional lymph node metastasis, I perform an operation with adapting itself.
If is PS0-1; to around 80 years old. Furthermore, when PS is expensive; to 70 years old.
Key exclusion criteria The case to be not worthy of Trendelenburg position with adaptation (glaucoma having poor control, the intracranial concomitant lesion). I evaluate the circulatory function and respiratory function.If these function are poor, there is not indication even if the patient is young.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki MIyauchi
Organization Ehime Univedrsity
Division name Department of Urology
Zip code
Address Shitsukawa, Toon, Ehime
TEL 089-960-5356
Email uroyuukictb12@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name uroyuukictb12@yahoo.co.jp
Organization Ehime University
Division name Medical department research partnership division
Zip code
Address Shitsukawa, Toon, Ehime
TEL 089-960-5172
Homepage URL
Email uroyuukictb12@yahoo.co.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Ehime University
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
2016 Year 01 Month 28 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 Completed
Date of protocol fixation
2015 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 28 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
2016 Year 01 Month 27 Day
Last modified on
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023933

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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