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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028263
Receipt No. R000032343
Scientific Title Efficacy and feasibility of robot-assisted radical cystectomy for muscle invasive bladder cancer.
Date of disclosure of the study information 2017/08/31
Last modified on 2019/01/17

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Basic information
Public title Efficacy and feasibility of robot-assisted radical cystectomy for muscle invasive bladder cancer.
Acronym Efficacy and feasibility of robot-assisted radical cystectomy for muscle invasive bladder cancer.
Scientific Title Efficacy and feasibility of robot-assisted radical cystectomy for muscle invasive bladder cancer.
Scientific Title:Acronym Efficacy and feasibility of robot-assisted radical cystectomy for muscle invasive bladder cancer.
Region
Japan

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

Objectives
Narrative objectives1 To examine the Efficacy and feasibility of robot-assisted radical cystectomy (RARC) for muscle invasive bladder cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total operation and console time.
Estimated blood loss.
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 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. Additionally, computerised tomography and/or magnetic resonance imaging are used to assess clinical tumour stage prior to surgery.
Key exclusion criteria 1. Patients who need to take antithrombogenic agents and/or have a tendency to bleed with abnormal coagulation test (PT 70-130%, APTT 76-130%) . 2. Patients who cannot be given a general anesthesia for their poor physical condition. 3. Patients with a history of extensive abdominal surgery. 4. Obese patients (body mass index over 30). 5. Patients with active infection diseases. 6. Patients who cannot keep 25 degree Trendelenburg position during operation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryosuke Ando
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Nephro-urology
Zip code
Address 1, Kawasumi,Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8266
Email ryo@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Ando
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Nephro-urology
Zip code
Address 1, Kawasumi,Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8266
Homepage URL
Email ryo@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Nephro-urology,
Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Department of Nephro-urology,
Nagoya City University Graduate School of Medical Sciences
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
2017 Year 08 Month 31 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 Terminated
Date of protocol fixation
2017 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 07 Month 17 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032343

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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