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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012258
Receipt No. R000014335
Scientific Title Validation of postoperative quality of recovery score japanese version:the QoR15J
Date of disclosure of the study information 2013/12/01
Last modified on 2018/11/16

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Basic information
Public title Validation of postoperative quality of recovery score japanese version:the QoR15J
Acronym PQRS15
Scientific Title Validation of postoperative quality of recovery score japanese version:the QoR15J
Scientific Title:Acronym PQRS15
Region
Japan

Condition
Condition The disease which need operatines under general anesthesia
Classification by specialty
Anesthesiology Operative medicine Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Validation of Japnese version of QoR15
Basic objectives2 Others
Basic objectives -Others Detecting the predictive factor of affecting quality of recovery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Validity
Reliability
Clinical Feasibility
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
85 years-old >=
Gender Male and Female
Key inclusion criteria The patients who undergo sergeries under general anesthesia and can answer the quessionnaire preoperatively and 2 days after operatines.
Key exclusion criteria Patients who cannot answer the questions of the QoR15. Patients who has mental disorder or consciousness
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuu Tanaka
Organization Nara Medical UNiv
Division name operation
Zip code
Address shijyoutyyo840 kashihara city
TEL 0744-29-8902
Email tanakayuu717@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuu Tanaka
Organization Nara Med Univ
Division name Anesthesiology
Zip code
Address shijyoutyyo840 kashihara city
TEL 0744-29-8902
Homepage URL
Email tanakayuu717@gmail.com

Sponsor
Institute Depaertment of Anesthesiology Nara Med Univ
Institute
Department

Funding Source
Organization Depaetment of Anesthesiology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 奈良県立医科大学

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 01 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 Completion of The QoR15 Japanese version according to guideline of cross cultural translation and Pilot test of The QoR15
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
2013 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 06 Month 30 Day
Date analysis concluded
2014 Year 07 Month 30 Day

Other
Other related information Preoperative QoR15 score,2ays after operation
Sex, social factor,weight, height operations anethetic technique
Complications


Management information
Registered date
2013 Year 11 Month 10 Day
Last modified on
2018 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014335

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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