UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010757 |
|---|---|
| Receipt number | R000012577 |
| Scientific Title | Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS) |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2016/02/27 20:25:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Acronym
Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Scientific Title
Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Scientific Title:Acronym
Validation of the Japanese version of the The Post-operative Quality Recovery Scale(PQRS)
Region
| Japan |
Condition
Condition
patients undergoing surgery with general anesthesia aged 6 years old or older
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recovery from surgery and anesthesia is an important factor. Some of the scales are developed to assess the degree of recovery but none of those are translated into Japanese. Post operative quality of recovery scale(PQRS) is a scale developed in seven countries. We translated PQRS with a permission from the author. Weather we can adopt this scale in Japan is unknown. We therefore assess the reliability and validity of this scale.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relation between PQRS and MMSE and QoR40, which is a gold standard scale in assessment of cognitive function and recovery from surgery
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
| 6 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing general anesthesia
Key exclusion criteria
emergent surgery
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawaguchi Masahiko |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744223051
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naito Yusuke |
Organization
Nara Prefectural Mimuro Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-14-16, Mimuro Sangocho, Ikomagun, Nara, Japan
TEL
0745-32-0505
Homepage URL
Sponsor or person
Institute
Nara Medical University, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
奈良県立三室病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Feasibility, reliability, validity of PQRSj were investigated. The main results are published in Journal of Anesthesiology
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Relation between MMSE and PQRS(cognitive function) and Relation between QoR40J and PQRS(Other than cognitive function)
Management information
Registered date
| 2013 | Year | 05 | Month | 19 | Day |
Last modified on
| 2016 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012577
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
