UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025465 |
|---|---|
| Receipt number | R000029307 |
| Scientific Title | The change in regional cerebral blood volume and oxygenation during robot-assisted laparoscopic radical prostatectomy |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2019/07/09 13:43:52 |
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Basic information
Public title
The change in regional cerebral blood volume and oxygenation during robot-assisted laparoscopic radical prostatectomy
Acronym
Cerebral blood flow oxygenation changes during robot-assisted laparoscopic radical prostatectomy
Scientific Title
The change in regional cerebral blood volume and oxygenation during robot-assisted laparoscopic radical prostatectomy
Scientific Title:Acronym
Cerebral blood flow oxygenation changes during robot-assisted laparoscopic radical prostatectomy
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Relationship between cerebral blood flow oxygenation change and hemodynamic change during robot-assisted laparoscopic radical prostatectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between change in regional cerebral blood volume and oxygenation measured by near-infrared spectroscopy and change in cardiac output and systemic vascular resistance measured by arterial pressure based cardiac output monitoring system during robot-assisted laparoscopic radical prostatectomy
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
Key inclusion criteria
Prostatic cancer patients scheduled for robot-assisted laparoscopic radical prostatectomy
Key exclusion criteria
Patients with severe systemic complication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Kondo |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
30-1,Oyaguchi-Kamicho,Itabashi-ku, Tokyo
TEL
03-3972-8111
kondo.yuko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Kondo |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
30-1,Oyaguchi-Kamicho,Itabashi-ku,Tokyo
TEL
03-3972-8111
Homepage URL
kondo.yuko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
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 | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design : Observational study(Case-control study)
Participants : Prostatic cancer patients scheduled for robot-assisted laparoscopic radical prostatectomy from October 2016 to March 2018
Observation items : Relationship between cerebral blood flow oxygenation change and hemodynamic change during robot-assisted laparoscopic radical prostatectomy
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029307
