UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011818 |
|---|---|
| Receipt number | R000013813 |
| Scientific Title | The effects of bloodletting on the increased intraocular pressure due to steep head-down position in parients undergoing robotic surgery |
| Date of disclosure of the study information | 2013/09/24 |
| Last modified on | 2016/03/12 21:40:52 |
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Basic information
Public title
The effects of bloodletting on the increased intraocular pressure due to steep head-down position in parients undergoing robotic surgery
Acronym
Evaluation of intraocular pressure in the robotic surgery
Scientific Title
The effects of bloodletting on the increased intraocular pressure due to steep head-down position in parients undergoing robotic surgery
Scientific Title:Acronym
Evaluation of intraocular pressure in the robotic surgery
Region
| Japan |
Condition
Condition
Urological and Gynecological Cancer
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of bloodletting from internal jugular vein on the increased intraocular pressure due to steep head-down position in patients undergoing robot assisted laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular presure
Key secondary outcomes
Blood pressure, Central venous pressure, cardiac output, Tidal volume of ventilator
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
bloodletting
Interventions/Control_2
without bloodletting
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 and Female
Key inclusion criteria
Patients with written informed consents
Key exclusion criteria
Patients with glaucoma, low cardiac function, severe cardiac vulve disease.
Patients without written informed consents
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetomo Niwa |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Anaesthesiology
Zip code
Address
Hirosaki Zaifucho 5, 036-8562, Japan
TEL
0172-39-5113
niwahide@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Noguchi |
Organization
Hirosaki University
Division name
Department of Anesthesiology
Zip code
Address
Hirosaki Zaifucho 5, 036-8562, Japan
TEL
0172-39-5113
Homepage URL
masuika@hirosaki-u.ac.jp
Sponsor or person
Institute
Hiriosaki university
Institute
Department
Personal name
Funding Source
Organization
Hirosaki university graduate school of mediceine, department of anesthesiology
Organization
Division
Category of Funding Organization
Non profit foundation
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
弘前大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 24 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2016 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013813
