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
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
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
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
