UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of visual function after robotic-assisted prostatectomy
Title of the study (Brief title)	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	Junji Egawa
Organization	Nara Medical University
Division name	Anesthesiology
Address	840 Shijo, Kashihara, Nara, Japan
TEL	0744-22-3051
Email	jun.e.m800@gmail.com

Public contact
Name of contact person	Junji Egawa
Organization	Nara Medical University
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 12 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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