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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000037302
Receipt No. R000042531
Scientific Title The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Date of disclosure of the study information 2020/01/29
Last modified on 2020/09/23

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Basic information
Public title The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Acronym The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Scientific Title The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Scientific Title:Acronym The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Region
Japan

Condition
Condition postoperative cognitive dysfunction
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of screening method and anesthesia management method for high risk patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The independent risk factors of early postoperative cognitive dysfunction of the elderly patients
Key secondary outcomes The incidence of early postoperative cognitive dysfunction of the elderly patients

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
75 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria 75 years-old or older
Key exclusion criteria Preoperative cognitive dysfunction
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Yamashita
Organization Kobe city medical center general hospital
Division name department of anesthesiology
Zip code 650047
Address Chuouku Minatojimaminamichou2-1-1,Kobe
TEL 0783024321
Email cantateveritas@ae.auone-net.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Yamashita
Organization Kobe city medical center general hospital
Division name department of anesthesiology
Zip code 650047
Address Chuouku Minatojimaminamichou2-1-1,Kobe
TEL 0783024321
Homepage URL
Email cantateveritas@ae.auone-net.jp

Sponsor
Institute Kobe city medical center general hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Not Applicable

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe city medical center general hospital
Address Chuouku Minatojimaminamichou2-1-1,Kobe
Tel 0783024321
Email cantateveritas@ae.auone-net.jp

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
2020 Year 01 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 303
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 Main results already published
Date of protocol fixation
2019 Year 07 Month 08 Day
Date of IRB
2019 Year 09 Month 28 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
2020 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information The incidence of postoperative cognitive dysfunction of the elderly patients and the multivariate analysis of risk factors.

Management information
Registered date
2019 Year 07 Month 08 Day
Last modified on
2020 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042531

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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