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Recruitment status
Unique ID issued by UMIN UMIN000024804
Receipt No. R000028541
Scientific Title Clinical study for rabot-assisted laparoscopic radical cystectomy
Date of disclosure of the study information 2016/12/01
Last modified on 2016/11/11

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Basic information
Public title Clinical study for rabot-assisted laparoscopic radical cystectomy
Acronym Clinical study for RARC
Scientific Title Clinical study for rabot-assisted laparoscopic radical cystectomy
Scientific Title:Acronym Clinical study for RARC
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to assess the ustility of robot-assisted laparoscopic radical cystectomy for patients with nonmetastatic muscle-invasive bladder cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perioperative adverse events
Key secondary outcomes operative time, blood loss

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 Patinets with nonmetastatic muscle invasive bladder cancer, who take part in this study, will be treated with 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with bladder cancer
Patients who agree to receive robot-assisted laparoscopic radical cystectomy
(Prior to start the study, wrriten informed consent will be required for all participants)
Key exclusion criteria 1. Patients with active double cancers
2. Patients possibly in pregnant
3. Patients who are not optimal candidates for laparoscopic surgery
4. Patients who are not candidates for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Miyake
Organization Hamamatsu University School of Medicine
Division name Department of Urology
Zip code
Address 1-20-1 Handayama, Higashi-Ku, Hamamatsu 431-3192, Japan
TEL 0534352306
Email hmiyake@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Miyake
Organization Hamamatsu University School of Medicine
Division name Department of Urology
Zip code
Address 1-20-1 Handayama, Higashi-Ku, Hamamatsu 431-3192, Japan
TEL 0534352306
Homepage URL
Email hmiyake@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
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 12 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
Date of protocol fixation
2016 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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

Management information
Registered date
2016 Year 11 Month 11 Day
Last modified on
2016 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028541

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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