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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042143
Receipt No. R000048097
Scientific Title Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty
Date of disclosure of the study information 2020/10/21
Last modified on 2021/03/23

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Basic information
Public title Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty
Acronym Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty
Scientific Title Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty
Scientific Title:Acronym Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty
Region
Japan

Condition
Condition Balloon Kyphoplasty
Classification by specialty
Orthopedics Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty
Basic objectives2 Others
Basic objectives -Others Incidence of postoperative cognitive dysfunction
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty
Key secondary outcomes Incidence of delirium
Length of hospital stay

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)ASA class 1 or 2
2)Elective surgery
3)A person with written voluntary informed consent based on the comprehensive explanation and understanding before joining this study
Key exclusion criteria 1)Patients who can not carry out some cognitive function tests before a surgical operation
2)Patients who are inappropriate for this study by physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yuka
Middle name
Last name Sato
Organization Omagari Kosei Medical Center
Division name Department of Anesthesia
Zip code 014-0027
Address 8-65 Omagari-Torimachi, Daisen, Akita, Japan
TEL +81-187-63-2111
Email yukabon0719@gmail.com

Public contact
Name of contact person
1st name Yuka
Middle name
Last name Sato
Organization Omagari Kosei Medical Center
Division name Department of Anesthesia
Zip code 014-0027
Address 8-65 Omagari-Torimachi, Daisen, Akita, Japan
TEL +81-187-63-2111
Homepage URL
Email yukabon0719@gmail.com

Sponsor
Institute Department of Anesthesia, Omagari Kosei Medical Center
Institute
Department

Funding Source
Organization Department of Anesthesia, Omagari Kosei Medical Center
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 Omagari Kosei Medical Center
Address 8-65 Omagari-Torimachi, Daisen, Akita, Japan
Tel +81-187-63-2111
Email yukabon0719@gmail.com

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 10 Month 21 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 No longer recruiting
Date of protocol fixation
2020 Year 10 Month 20 Day
Date of IRB
2020 Year 10 Month 20 Day
Anticipated trial start date
2020 Year 10 Month 20 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 10 Month 16 Day
Last modified on
2021 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048097

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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