UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042290
Receipt number R000043374
Scientific Title Validation, Feasibility and Reliability of postoperative quality of recovery score Japanese version:the QoR15J
Date of disclosure of the study information 2020/10/30
Last modified on 2020/10/30 10:08:05

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Basic information

Public title

Validation, Feasibility and Reliability of postoperative quality of recovery score Japanese version:the QoR15J

Acronym

PQRS15

Scientific Title

Validation, Feasibility and Reliability of postoperative quality of recovery score Japanese version:the QoR15J

Scientific Title:Acronym

PQRS15

Region

Japan


Condition

Condition

Patients undergoing surgery with general anesthesia

Classification by specialty

Surgery in general Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess fesiablity, validity and reliability of J-QOR15

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The score of QOR15 24h later after surgery

Key secondary outcomes

The score of QOR15 25 and 48 later after surgery


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


Not applicable

Gender

Male and Female

Key inclusion criteria

patients >- 20-year-old
Paritens who can understand Japanese
Patients without intubation after surgery

Key exclusion criteria

Patients with cognitive dysfunction
Patients who cannnot write by themselves
Psychiatric patients

Target sample size

170


Research contact person

Name of lead principal investigator

1st name ida
Middle name
Last name Mitsuru

Organization

Nara Medical University

Division name

Anesthesiology

Zip code

6348521

Address

Nara Kashihara Shijo-cho840

TEL

09079627114

Email

nwnh0131@yahoo.co.jp


Public contact

Name of contact person

1st name Mitsuru
Middle name
Last name Ida

Organization

Nara Medical University

Division name

Anesthesiology

Zip code

6348521

Address

Nara Kashihara Shijo-cho840

TEL

09079627114

Homepage URL


Email

nwnh0131@yahoo.co.jp


Sponsor or person

Institute

Nara Medical Unicersity

Institute

Department

Personal name



Funding Source

Organization

None

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

Nara Medical University

Address

Nara Kashihara Shijo-cho840

Tel

09079627114

Email

nwnh0131@yahoo.co.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

nnn

Org. issuing International ID_1

mmm

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 30 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

Preinitiation

Date of protocol fixation

2019 Year 09 Month 08 Day

Date of IRB


Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2019 Year 12 Month 30 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 30 Day

Last modified on

2020 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043374


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name