UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012545 |
|---|---|
| Receipt number | R000014681 |
| Scientific Title | A study of safety and efficacy of robot assisted surgery |
| Date of disclosure of the study information | 2013/12/11 |
| Last modified on | 2018/12/17 14:45:44 |
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Basic information
Public title
A study of safety and efficacy of robot assisted surgery
Acronym
Aimed to find out how inflammation will be develop during robot assisted surgery
Scientific Title
A study of safety and efficacy of robot assisted surgery
Scientific Title:Acronym
Aimed to find out how inflammation will be develop during robot assisted surgery
Region
| Japan |
Condition
Condition
malignant tumor of the bladder
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aimed to find out how inflammation will be develop during robot assisted surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate safety and efficacy of robot assisted surgery with quantifing stress and inflammation related substance.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who has robot assisted surgery for bladder malignant tumor
Key exclusion criteria
Patient wothout inforned consent, who has robot assisted surgery for bladder malignant tumor
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kushikata |
Organization
Hirosaki University
Division name
Department of Anesthesiology, Graduate School of Medicine
Zip code
Address
Zaifu 5, Hirosaki, Aomori
TEL
0172335111
tetsuyak@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kushikata |
Organization
Hirosaki University
Division name
Department of Anesthesiology, Graduate School of Medicine
Zip code
Address
Zaifu 5, Hirosaki, Aomori
TEL
0172335111
Homepage URL
tetsuyak@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
| 2013 | Year | 12 | Month | 11 | 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
analysis data obtained
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
| 2013 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Robot-assisted surgery has a merit of low-invasive. It is expected to reduce blood-loss and wound size even though in case of high invasive surgery like total cystectomy.
Robot-assisted surgery has different approach from ordinary laparotomy; thus, it may possible to develop unexpected complication mesenteric traction syndrome. Purpose of this study is to evaluate safety and efficacy of a robot-assisted surgery. We investigate usual blood examination and changes in stress/inflammation related substances (catecholamine, cortisol, orexin, urotensin II, procalcitonin, presepsin, endotoxin, etc.).
Management information
Registered date
| 2013 | Year | 12 | Month | 11 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014681
