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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025461
Receipt No. R000029085
Scientific Title Alteration of intraocular pressure in patients who underwent robot-assisted laparoscopic prostatectomies (RALPs)
Date of disclosure of the study information 2017/02/01
Last modified on 2016/12/28

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Basic information
Public title Alteration of intraocular pressure in patients who underwent robot-assisted
laparoscopic prostatectomies (RALPs)
Acronym Alteration of intraocular pressure in patients who underwent robot-assisted
laparoscopic prostatectomies (RALPs)
Scientific Title Alteration of intraocular pressure in patients who underwent robot-assisted
laparoscopic prostatectomies (RALPs)
Scientific Title:Acronym Alteration of intraocular pressure in patients who underwent robot-assisted
laparoscopic prostatectomies (RALPs)
Region
Japan

Condition
Condition prostatic carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We would like to know grade of elevation of ocular pressure during surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measurement of intraocular pressure by an anesthesiologist during surgery
Key secondary outcomes duration of operation
duration of prone position
Used amount of atropine
and vasopressor drugs
blood pressure
Bleeding volume
Infusion volume

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
40 years-old <=
Age-upper limit
100 years-old >=
Gender Male
Key inclusion criteria Measurement of intraocular pressure is thought to be safety as ophthalmologist.
Key exclusion criteria ophthalmologist judge the risk of estimation of intraocular pressure, for example, eyeground abnormality
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamie Takenami
Organization Kitasato University School of Medicine
Division name Anesthesiology
Zip code
Address 1-15-1 Kitasato, Sagamihara, Minami-ku
TEL 042-778-8111
Email takenami@med.kitazato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamie Takenami
Organization Kitasato University School of Medicine
Division name Anesthesiology
Zip code
Address 1-15-1 Kitasato, Sagamihara, Minami-ku
TEL 042-778-8111
Homepage URL
Email takenami@med.kitazato-u.ac.jp

Sponsor
Institute Department of Aensthesiology,
Kitasato Univrtsity School of Medicine
Institute
Department

Funding Source
Organization Kitasato Univrtsity Hospital
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We don't use any drug except usual anesthetic drugs
Twice estimation of intraocular pressure with Tonopen by ophthalmologist on the day before surgery.
Ten times estimation of intraocular pressure with Tonopen by anestheologist on the day of surgery.

Management information
Registered date
2016 Year 12 Month 28 Day
Last modified on
2016 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029085

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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