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 2019/08/23 09:31:52

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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 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

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

Value
https://center6.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