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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033268
Receipt No. 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 2018/08/07

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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
Middle name
Last name Isao Tsuneyoshi
Organization Medicine of Miyazaki University
Division name Department of Anesthesiology
Zip code
Address 5200 Kihara Kiyotake Miyazaki
TEL 0985-85-2970
Email isao45@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koki Yamashita
Organization Medicine of Miyazaki University
Division name Department of Anesthesiology
Zip code
Address 5200 Kihara Kiyotake Miyazaki
TEL 0985-85-2970
Homepage URL
Email kokiy@par.odn.ne.jp

Sponsor
Institute Miyazaki University
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2018 Year 08 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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