UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033268 |
|---|---|
| Receipt number | R000036903 |
| Scientific Title | Validation of Postoperative Quality of Recovery Scale(PostopQRS) in Japan |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2021/03/31 13:12:39 |
* 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 Postoperative Quality of Recovery Scale(PostopQRS) in Japan
Acronym
PostopQRS study in Japan
Scientific Title
Validation of Postoperative Quality of Recovery Scale(PostopQRS) in Japan
Scientific Title:Acronym
PostopQRS study in Japan
Region
| Japan |
Condition
Condition
Patient of elective surgery
Classification by specialty
| Anesthesiology | Operative medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate whether effective Postoperative Quality of Recovery Scale(PostopQRS) in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
normal recovery after 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are scheduled to be awake and extubated early postoperatively
2. Patients who obtained written consent by the patient himself / herself
Key exclusion criteria
1.Patients with dementia or a condition similar disorder
2.Patients who are difficult to extubate early postoperatively
3.Patients judged inappropriate by the person responsible for implementation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Tsuneyoshi |
Organization
Medicine of Miyazaki University
Division name
Department of Anesthesiology
Zip code
8891692
Address
5200 Kihara Kiyotake Miyazaki
TEL
0985-85-2970
isao45@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Yamashita |
Organization
Medicine of Miyazaki University
Division name
Department of Anesthesiology
Zip code
8891692
Address
5200 Kihara Kiyotake Miyazaki
TEL
0985-85-2970
Homepage URL
kokiy@par.odn.ne.jp
Sponsor or person
Institute
Miyazaki University
Institute
Department
Personal name
Funding Source
Organization
Miyazaki University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University Hospital of Miyazaki
Address
5200 Kihara Kiyotake Miyazaki
Tel
0985-85-1510
igakubu_kenkyu@med.miyazaki-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
52
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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 02 | Day |
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036903
