UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022798 |
|---|---|
| Receipt number | R000026275 |
| Scientific Title | Risk factors related with postoperative delirium after spine surgery |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2016/06/20 12:39:22 |
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Basic information
Public title
Risk factors related with postoperative delirium after spine surgery
Acronym
Risk factors related with postoperative delirium
Scientific Title
Risk factors related with postoperative delirium after spine surgery
Scientific Title:Acronym
Risk factors related with postoperative delirium
Region
| Japan |
Condition
Condition
patients with spine surgery
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of factors related with postoperative delirium after spine surgery
Basic objectives2
Others
Basic objectives -Others
Comparison of factors related with postoperative delirium after spine surgery
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of risk foactors in patients with postoperative delirium
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
pstients with spine surgery
Key exclusion criteria
patients with dementia.
patients with confusion.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Tsukamoto |
Organization
Keiyu orthpedic surgery hospital
Division name
Anesthesilogy
Zip code
Address
1741, hatsuki, tatebayashi, gunma
TEL
0276-72-6000
tsukamoton2@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Tsukamoto |
Organization
keiyu orthpedic surgery hospital
Division name
anesthesilogy
Zip code
Address
1741-, hatsuki, tatebayashi, gunma
TEL
0276-72-6000
Homepage URL
tsukamoton2@gmail.com
Sponsor or person
Institute
Keiyu orthpedic surgery hospital
Institute
Department
Personal name
Funding Source
Organization
self founding
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
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
慶友整形外科病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using CAM analysis sheet, we will identify the patients with postoperative delirium. Then, we will analyze the brisk factor s related to postoperative delirium in patients undergoing spine surgery.
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2016 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026275
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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