UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012360 |
|---|---|
| Receipt number | R000014449 |
| Scientific Title | Influence of the intraocular pressure in the da Vinci operation. |
| Date of disclosure of the study information | 2013/11/21 |
| Last modified on | 2018/02/11 13:12:32 |
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Basic information
Public title
Influence of the intraocular pressure in the da Vinci operation.
Acronym
Influence of the intraocular pressure in the da Vinci operation.
Scientific Title
Influence of the intraocular pressure in the da Vinci operation.
Scientific Title:Acronym
Influence of the intraocular pressure in the da Vinci operation.
Region
| Japan |
Condition
Condition
Prostatic cancer
Classification by specialty
| Ophthalmology | Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By the da Vinci operation, since a prolonged operation is enforced by head-down tilt,eye complications have been reported.
We measure the change before and behind the way of the intraocular pressure of the patient who undergoes the da Vinci operation, and investigate relation with eye complications this time.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
eye complication
Key secondary outcomes
Intraocular pressure
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Prostate gland patient(ASA 1 and 2) .
The patient by whom operation hope was done after IC of the da Vinci operation.
Key exclusion criteria
ASA 3 or more patients.
A patient with eye complications.
A patient with other critical complications.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mutsuko Omori |
Organization
Himeji Red Cross hospital
Division name
The department of anesthesia
Zip code
Address
1-12-1, Shimo-teno, Himeji-shi, Hyogo-ken
TEL
079-294-2251
chezmu@hrc-hp.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | koukyou suita |
Organization
Himeji Red Cross hospital
Division name
The department of anesthesia
Zip code
Address
1-12-1, Shimo-teno, Himeji-shi, Hyogo-ken
TEL
079-294-2251
Homepage URL
passkey55555@gmail.com
Sponsor or person
Institute
Himeji Red Cross hospital
Institute
Department
Personal name
Funding Source
Organization
Himeji Red Cross hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
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
姫路赤十字病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 21 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 30 | Day |
Other
Other related information
Before an operation -- intraocular pressure is measured after the operation.
Management information
Registered date
| 2013 | Year | 11 | Month | 20 | Day |
Last modified on
| 2018 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014449
| 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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