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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010757
Receipt No. R000012577
Scientific Title Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Date of disclosure of the study information 2013/06/01
Last modified on 2016/02/27

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Basic information
Public title Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Acronym Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Scientific Title Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Scientific Title:Acronym Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Region
Japan

Condition
Condition patients undergoing surgery with general anesthesia aged 6 years old or older
Classification by specialty
Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recovery from surgery and anesthesia is an important factor. Some of the scales are developed to assess the degree of recovery but none of those are translated into Japanese. Post operative quality of recovery scale(PQRS) is a scale developed in seven countries. We translated PQRS with a permission from the author. Weather we can adopt this scale in Japan is unknown. We therefore assess the reliability and validity of this scale.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Relation between PQRS and MMSE and QoR40, which is a gold standard scale in assessment of cognitive function and recovery from surgery
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
6 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients undergoing general anesthesia
Key exclusion criteria emergent surgery
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawaguchi Masahiko
Organization Nara Medical University
Division name Department of Anesthesiology
Zip code
Address 840 Shijo-cho, Kashihara, Nara, Japan
TEL 0744223051
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naito Yusuke
Organization Nara Prefectural Mimuro Hospital
Division name Department of Anesthesiology
Zip code
Address 1-14-16, Mimuro Sangocho, Ikomagun, Nara, Japan
TEL 0745-32-0505
Homepage URL
Email

Sponsor
Institute Nara Medical University, Department of Anesthesiology
Institute
Department

Funding Source
Organization None
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
Email

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 奈良県立三室病院(奈良県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 01 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
Results
Feasibility, reliability, validity of PQRSj were investigated. The main results are published in Journal of Anesthesiology
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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 04 Month 01 Day
Date trial data considered complete
2014 Year 04 Month 01 Day
Date analysis concluded
2014 Year 06 Month 01 Day

Other
Other related information Relation between MMSE and PQRS(cognitive function) and Relation between QoR40J and PQRS(Other than cognitive function)

Management information
Registered date
2013 Year 05 Month 19 Day
Last modified on
2016 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012577

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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