UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes of cerebral regional oxygen saturation measured by near-infrared spectroscopy at pneumoperitoneum and Trendelenburg position during robotic-assisted endoscopic prostatic surgery.
Title of the study (Brief title)	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	Tadahiko Ishiyama
Organization	University of Yamanashi, Faculty of Medicine, University of Yamanashi Hospital
Division name	Surgical Center
Address	1110 Shimokato, Chuo, Yamanashi
TEL	055-273-1111
Email	ishiyama@yamanashi.ac.jp

Public contact
Name of contact person	Tadahiko Ishiyama
Organization	University of Yamanashi, Faculty of Medicine, University of Yamanashi Hospital
Division name	Surgical Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030123