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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026227
Receipt No. R000030123
Scientific Title Changes of cerebral regional oxygen saturation measured by near-infrared spectroscopy at pneumoperitoneum and Trendelenburg position during robotic-assisted endoscopic prostatic surgery.
Date of disclosure of the study information 2017/02/20
Last modified on 2018/02/21

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Basic information
Public title Changes of cerebral regional oxygen saturation measured by near-infrared spectroscopy at pneumoperitoneum and Trendelenburg position during robotic-assisted endoscopic prostatic surgery.
Acronym Changes of cerebral regional oxygen saturation during robotic-assisted endoscopic prostatic surgery.
Scientific Title Changes of cerebral regional oxygen saturation measured by near-infrared spectroscopy at pneumoperitoneum and Trendelenburg position during robotic-assisted endoscopic prostatic surgery.
Scientific Title:Acronym Changes of cerebral regional oxygen saturation during robotic-assisted endoscopic prostatic surgery.
Region
Japan

Condition
Condition Prostatic cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the changes of cerebral regional tissue oxygen saturation at pneumoperitoneum and Trendelenburg position during robotic-assisted endoscopic prostatic surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of cerebral regional tissue oxygen saturation before and after pneumoperitoneum and Trendelenburg position.
Key secondary outcomes Changes of mean arterial blood pressure, arterial oxygen tension, arterial carbon dioxide tension, arterial oxygen saturation, percutaneous arterial oxygen saturation, and bispectral index before and after pneumoperitoneum.
Changes of mean arterial blood pressure, arterial oxygen tension, arterial carbon dioxide tension, arterial oxygen saturation, percutaneous arterial oxygen saturation, and bispectral index before and after Trendelenburg position.

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

Not applicable
Gender Male
Key inclusion criteria Patients who undergo robotic assisted endoscopic prostatic surgery.
Key exclusion criteria Patients having history of cerebral diseases such as cerebral infarction, cerebral hemorrhage, transient ischemic attack, subarachnoid hemorrhage.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadahiko Ishiyama
Organization University of Yamanashi, Faculty of Medicine, University of Yamanashi Hospital
Division name Surgical Center
Zip code
Address 1110 Shimokato, Chuo, Yamanashi
TEL 055-273-1111
Email ishiyama@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadahiko Ishiyama
Organization University of Yamanashi, Faculty of Medicine, University of Yamanashi Hospital
Division name Surgical Center
Zip code
Address 1110 Shimokato, Chuo, Yamanashi
TEL 055-273-1111
Homepage URL
Email ishiyama@yamanashi.ac.jp

Sponsor
Institute University of Yamanashi
Institute
Department

Funding Source
Organization University of Yamanashi
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 20 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
2015 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None.

Management information
Registered date
2017 Year 02 Month 20 Day
Last modified on
2018 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030123

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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