UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006798 |
|---|---|
| Receipt number | R000007959 |
| Scientific Title | The effects of steep trendelenburg positioning on intraocular pressure during Robotic surgery |
| Date of disclosure of the study information | 2012/01/15 |
| Last modified on | 2011/11/30 14:43:15 |
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Basic information
Public title
The effects of steep trendelenburg positioning on intraocular pressure during Robotic surgery
Acronym
The effects of steep trendelenburg positioning on intraocular pressure during Robotic surgery
Scientific Title
The effects of steep trendelenburg positioning on intraocular pressure during Robotic surgery
Scientific Title:Acronym
The effects of steep trendelenburg positioning on intraocular pressure during Robotic surgery
Region
| Japan |
Condition
Condition
Patients undergoing robotic surgery with steep trendelenburg positioning
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is planned in order to evaluate the effects of positioning and pneumoperitoneum on the intraocular pressure during Robotic surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurements of intraocular pressure during perioperative periods
Key secondary outcomes
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 and Female
Key inclusion criteria
Patients undergoing Robotic surgery with steep trendelenburg position
Key exclusion criteria
glaucoma, abnormality in the ophthalmus or cornea
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kahoru Nishina |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Kusunoki-cho 7-5-1 Chuo-ku Kobe
TEL
078-382-6172
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Kusunoki-cho 7-5-1 Chuo-ku Kobe
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Graduate School of Medicine
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
神戸大学大学院医学研究科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 15 | 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
| 2012 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients undergoing the defined surgeries are enrolled in this prospective study. The correlations between the changes in intraocular pressure and patients characteristics, hemodynamics, blood gas analysis, and duration of surgery are evaluated.
Management information
Registered date
| 2011 | Year | 11 | Month | 30 | Day |
Last modified on
| 2011 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007959
