UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037300 |
|---|---|
| Receipt number | R000042526 |
| Scientific Title | Otologic surgery and quality of life(QOL) |
| Date of disclosure of the study information | 2019/07/07 |
| Last modified on | 2019/07/07 20:21:40 |
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Basic information
Public title
analysis on otologic surgery and quality of life(QOL)
Acronym
Otologic surgery and QOL
Scientific Title
Otologic surgery and quality of life(QOL)
Scientific Title:Acronym
Otologic surgery and QOL
Region
| Japan |
Condition
Condition
ear (hearing loss) disease which surgery needed
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we evaluate otologic surgery and QOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hearing outcome after surgery and QOL
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)nornal hearing people (volunteer )
2)patients who had otologic surgery
Key exclusion criteria
1)pregnant patients
2)cardiac and pulmonary failures
3)variable factors including uncontrolled DM affected hearing outcome
4) others when doctors judged the patinets excludud.
Target sample size
3960
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio Univeristy School of medicine
Division name
otolaryngology
Zip code
1608582
Address
35 Shinanomachi Shinjuku
TEL
0333531211
shokanza@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio Univeristy School of medicine
Division name
otolaryngology
Zip code
1608582
Address
35 Shinanomachi Shinjuk
TEL
0333531211
Homepage URL
skan@keio.jp
Sponsor or person
Institute
Keio Univeristy
Institute
Department
Personal name
Funding Source
Organization
Japan Otologic Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
57
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB Keio Univeristy
Address
35 Shinanomachi Shinjuku
Tel
0333531211
skan@keio.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
| 2019 | Year | 07 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
working group of Japan otologic society
Management information
Registered date
| 2019 | Year | 07 | Month | 07 | Day |
Last modified on
| 2019 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042526
