UMIN-CTR Clinical Trial

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
Email	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
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	University Hospital of Miyazaki
Address	5200 Kihara Kiyotake Miyazaki
Tel	0985-85-1510
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036903