UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of the intraocular pressure in the da Vinci operation.
Title of the study (Brief title)	Influence of the intraocular pressure in the da Vinci operation.
Region	Japan

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

Objectives
Narrative objectives1	By the da Vinci operation, since a prolonged operation is enforced by head-down tilt,eye complications have been reported. We measure the change before and behind the way of the intraocular pressure of the patient who undergoes the da Vinci operation, and investigate relation with eye complications this time.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	eye complication
Key secondary outcomes	Intraocular pressure

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	90 years-old >
Gender	Male
Key inclusion criteria	Prostate gland patient(ASA 1 and 2) . The patient by whom operation hope was done after IC of the da Vinci operation.
Key exclusion criteria	ASA 3 or more patients. A patient with eye complications. A patient with other critical complications.
Target sample size	50

Research contact person
Name of lead principal investigator	Mutsuko Omori
Organization	Himeji Red Cross hospital
Division name	The department of anesthesia
Address	1-12-1, Shimo-teno, Himeji-shi, Hyogo-ken
TEL	079-294-2251
Email	chezmu@hrc-hp.com

Public contact
Name of contact person	koukyou suita
Organization	Himeji Red Cross hospital
Division name	The department of anesthesia
Address	1-12-1, Shimo-teno, Himeji-shi, Hyogo-ken
TEL	079-294-2251
Homepage URL
Email	passkey55555@gmail.com

Sponsor
Institute	Himeji Red Cross hospital
Institute
Department

Funding Source
Organization	Himeji Red Cross hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	japan

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	姫路赤十字病院

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 21 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2014 Year 10 Month 31 Day
Date of closure to data entry	2014 Year 11 Month 30 Day
Date trial data considered complete	2014 Year 11 Month 30 Day
Date analysis concluded	2014 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Before an operation -- intraocular pressure is measured after the operation.

Management information
Registered date	2013 Year 11 Month 20 Day
Last modified on	2018 Year 02 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014449