UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012258
Receipt number 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 14:20:29

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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 or person

Institute

Depaertment of Anesthesiology Nara Med Univ

Institute

Department

Personal name



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

Value
https://center6.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