UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014973 |
|---|---|
| Receipt number | R000017391 |
| Scientific Title | The effects of intraocular pressure during Robot assisted laparoscopic prostatectomy |
| Date of disclosure of the study information | 2014/08/27 |
| Last modified on | 2015/02/28 10:22:34 |
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Basic information
Public title
The effects of intraocular pressure during Robot assisted laparoscopic prostatectomy
Acronym
The effects of intraocular pressure during Robot assisted laparoscopic prostatectomy
Scientific Title
The effects of intraocular pressure during Robot assisted laparoscopic prostatectomy
Scientific Title:Acronym
The effects of intraocular pressure during Robot assisted laparoscopic prostatectomy
Region
| Japan |
Condition
Condition
prostatic carcinoma
Classification by specialty
| Ophthalmology | Urology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate th intraocular pressure during robotic assisted laparoscopic prostatectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We perforemd intraocular pressure at 5 time points. Just after intubation, 30min after steep trendenburg position, 90min after steep trendenburg position, 150min after steep trendenburg position, At the end of operation
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
ophthalmotonometry during operation. (5 time points)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
The patinet with prostatic carcinoma using robotic assisted laparoscopic prostatectomy.
Key exclusion criteria
Glaucoma,
cerebral aneurysm ,
ASA physical status 3,
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Echigo Noriyuki |
Organization
Yokohama Rosai Hospital
Division name
Anestheisa
Zip code
Address
3211 kodukue-cho kouhoku yokomama city kanagawa
TEL
0454748111
echigo@yokohamah.rofuku.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Echigo Noriyuki |
Organization
Yokohama Rosai Hospital
Division name
Anesthesia
Zip code
Address
3211 kodukue-cho kouhoku yokomama city kanagawa
TEL
0454748111
Homepage URL
nechigo@yokohamah.rofuku.go.jp
Sponsor or person
Institute
Yokohama rosai hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
横浜労災病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2015 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017391
