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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025578
Receipt No. 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

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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
Email 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
Email jun.e.m800@gmail.com

Sponsor
Institute Department of Anesthesiology, Nara Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029428

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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