UMIN-CTR Clinical Trial

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
Email	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
Email	skan@keio.jp

Sponsor
Institute	Keio Univeristy
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042526