UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025578 |
|---|---|
| Receipt number | R000029428 |
| Scientific Title | Evaluation of visual function after robotic-assisted prostatectomy |
| Date of disclosure of the study information | 2017/01/09 |
| Last modified on | 2017/01/09 02:00:15 |
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Basic information
Public title
Evaluation of visual function after robotic-assisted prostatectomy
Acronym
V-RAP study
(Visual function after Robotic- Assisted Prostatectomy)
Scientific Title
Evaluation of visual function after robotic-assisted prostatectomy
Scientific Title:Acronym
V-RAP study
(Visual function after Robotic- Assisted Prostatectomy)
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the visual function after robotic-assisted prostatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of visual dysfunction (NEI VFQ-25) after robotic-assisted prostatectomy
Key secondary outcomes
The association with the postoperative visual dysfunction and intraoperative optic nerve sheath diameter
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Key inclusion criteria
1) Patients scheduled for elective robotic-assisted prostatectomy
2) Patients who can undergo visual function questionnaire (NEI VFQ-25)
Key exclusion criteria
1) eye disease (cataract, glaucoma, retinal detachment, diabetic retinopathy, age-related macular degeneration etc.)
2) neurological disorder (cerebral aneurysm, intracranial hypertension etc.)
3) psychological disorder
4) cognitive dysfunction
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Egawa |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
Address
840 Shijo, Kashihara, Nara, Japan
TEL
0744-22-3051
jun.e.m800@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Egawa |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
Address
840 Shijo, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
jun.e.m800@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nara Medical 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
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 | 01 | Month | 09 | 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 | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate postoperative visual function using NEI VFQ-25 questionnaire in patients who undergo robotic-assisted prostatectomy.
We also evaluate the association between postoperative visual function and intraoperative optic nerve sheath diameter.
Management information
Registered date
| 2017 | Year | 01 | Month | 09 | Day |
Last modified on
| 2017 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029428
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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