UMIN-CTR Clinical Trial

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
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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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