UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021096 |
|---|---|
| Receipt number | R000024336 |
| Scientific Title | Measuring quality of postoperative functional disorder rating scale |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2025/05/22 07:41:01 |
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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
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
nwnh0131@yahoo.co.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Completed
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
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024336
