UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028640 |
|---|---|
| Receipt number | 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 | 2020/08/13 09:15:55 |
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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
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
makiya@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Urology, Yokohama City University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 10 | Day |
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
| 2020 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032779
