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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021096
Receipt No. R000024336
Scientific Title Measuring quality of postoperative functional disorder rating scale
Date of disclosure of the study information 2016/04/01
Last modified on 2019/08/23

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Basic information
Public title Measuring quality of postoperative functional disorder rating scale
Acronym Measuring quality of postoperative functional disorder rating scale
Scientific Title Measuring quality of postoperative functional disorder rating scale
Scientific Title:Acronym Measuring quality of postoperative functional disorder rating scale
Region
Japan

Condition
Condition Disease undergoing surgery in anesthesiology management
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to test the acceptability and feasibility of using WHODAS2.0,SF-8, TMIG Index as outcome measure before and after surgery
Basic objectives2 Others
Basic objectives -Others to identify when we should be administering the WHODAS2.0,SF-8, TMIG Index.
Identify the proper cutoff value on WHODAS2.0
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes WHODAS2.0,SF-8, TMIG Index
Key secondary outcomes Acceptability and feasibility
Validity
Reliability
Resposiveness

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
55 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing surgery in anesthesiology management
Patients who can answer the questionnaire
Key exclusion criteria Patients who can't answer to TMIG Index, SF 8, WHODAS2.
Patients who undergo re-operation in hospitalization.
Patients who can't well understand Japanese
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Kawaguchi
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348521
Address Kashihara city shijyo-cho 840
TEL 0744-22-3051
Email drjkawa@gmail.com

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348521
Address Kashihara city shijyo-cho 840
TEL 0744-22-3051
Homepage URL
Email nwnh0131@yahoo.co.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University
Address Shijo-machi 840 Nara Medical University
Tel 09079627114
Email nwnh0131@yahoo.co.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
2016 Year 04 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 4000
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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 15 Day
Date of IRB
2015 Year 12 Month 25 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cohort
Everyone who meet the selection criteria in patients who underwent surgery at our facility in April 2016-March 2017

Management information
Registered date
2016 Year 02 Month 19 Day
Last modified on
2019 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024336

Research Plan
Registered date File name
2016/07/08 倫理委員会 変更後.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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