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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006798
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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