UMIN-CTR Clinical Trial

Basic information
Public title	Hearing test during middle ear surgery
Acronym	Hearing test during middle ear surgery
Scientific Title	Efficiency of intraoperative hearing test using ASSR
Scientific Title:Acronym	Intraoperative hearing test using ASSR
Region	Japan

Condition
Condition	chronic otitis media, cholesteatoma, ossicular disruption, otosclerosis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare hearing threshold shift of ASSR and hearing threshold shift by audiometry in order to prove efficiency of intraoperative measurement of hearing by ASSR
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison thresholds shift of ASSR during operation and hearing threshold shift by audiometer before and after operation.
Key secondary outcomes	measuring time

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. Patients whose pure tone audiometey are available before operation. 2. Patients who undergo operations with possibility of hearing improvement such as tympanplasty, stapes surgery and myringoplasty. 3. Patients (or their guardians if they are not adults) who agree to join this study by consent form.
Key exclusion criteria	1. Inappropriate patients judged by operators ex. patients whose hearing may not improve. 2. Patients who undergo operation by local anesthesia.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Taisuke Middle name Last name Kobayashi
Organization	Kochi University
Division name	Department of Otolaryngology, Medical School
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL	0888802393
Email	tkobayashi@kochi-u.ac.jp

Public contact
Name of contact person	1st name Taisuke Middle name Last name Kobayashi
Organization	Kochi University
Division name	Department of Otolaryngology, Medical School
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL	0888802393
Homepage URL
Email	tkobayashi@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Kochi University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kochi University
Address	Kohasu, Oko-cho, Nankoku-shi, Kochi
Tel	088-880-2180
Email	is21@kochi-u.ac.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	高知大学医学部医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	8
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	2019 Year 08 Month 31 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 10 Month 21 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	Results of ASSR during operation and pure tone audiometry before and after operation are investigated. Time for measuring ASSR is also investigated.

Management information
Registered date	2019 Year 08 Month 07 Day
Last modified on	2020 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042876