UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025461 |
|---|---|
| Receipt number | R000029085 |
| Scientific Title | Alteration of intraocular pressure in patients who underwent robot-assisted laparoscopic prostatectomies (RALPs) |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2016/12/28 16:36:50 |
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Basic information
Public title
Alteration of intraocular pressure in patients who underwent robot-assisted
laparoscopic prostatectomies (RALPs)
Acronym
Alteration of intraocular pressure in patients who underwent robot-assisted
laparoscopic prostatectomies (RALPs)
Scientific Title
Alteration of intraocular pressure in patients who underwent robot-assisted
laparoscopic prostatectomies (RALPs)
Scientific Title:Acronym
Alteration of intraocular pressure in patients who underwent robot-assisted
laparoscopic prostatectomies (RALPs)
Region
| Japan |
Condition
Condition
prostatic carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We would like to know grade of elevation of ocular pressure during surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measurement of intraocular pressure by an anesthesiologist during surgery
Key secondary outcomes
duration of operation
duration of prone position
Used amount of atropine
and vasopressor drugs
blood pressure
Bleeding volume
Infusion volume
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
Measurement of intraocular pressure is thought to be safety as ophthalmologist.
Key exclusion criteria
ophthalmologist judge the risk of estimation of intraocular pressure, for example, eyeground abnormality
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamie Takenami |
Organization
Kitasato University School of Medicine
Division name
Anesthesiology
Zip code
Address
1-15-1 Kitasato, Sagamihara, Minami-ku
TEL
042-778-8111
takenami@med.kitazato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamie Takenami |
Organization
Kitasato University School of Medicine
Division name
Anesthesiology
Zip code
Address
1-15-1 Kitasato, Sagamihara, Minami-ku
TEL
042-778-8111
Homepage URL
takenami@med.kitazato-u.ac.jp
Sponsor or person
Institute
Department of Aensthesiology,
Kitasato Univrtsity School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato Univrtsity Hospital
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We don't use any drug except usual anesthetic drugs
Twice estimation of intraocular pressure with Tonopen by ophthalmologist on the day before surgery.
Ten times estimation of intraocular pressure with Tonopen by anestheologist on the day of surgery.
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2016 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029085
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
