UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028263 |
|---|---|
| Receipt number | 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 12:34:29 |
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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
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
ryo@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Nephro-urology,
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032343
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
