UMIN-CTR Clinical Trial

Basic information
Public title	The changes of taste and somatosensory function after middle ear surgery
Acronym	The changes of taste and somatosensory function after middle ear surgery
Scientific Title	The changes of taste and somatosensory function after middle ear surgery
Scientific Title:Acronym	The changes of taste and somatosensory function after middle ear surgery
Region	Japan

Condition
Condition	Middle ear diseases such as chronic otitis media, osteomyolitis otitis media, otosclerosis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate changes in taste and somatosensory function of tongue after middle ear surgery
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Taste and somatosensory function of tongue after middle ear surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Taste and somatosensory functions are assessed using the electrogustometer, 2-point discriminator and electrostimulator. These tests are administered before surgery and 2 weeks, 1 months, 6 months, and 1 year after the surgery.
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	7 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who underwent middle ear surgery for the first time
Key exclusion criteria	Patients wearing pacemakers or cochlear implants Second and subsequent surgical cases
Target sample size	190

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masafumi Sakagami
Organization	Hyogo College of Medicine
Division name	Department of Otolaryngology-Head and Neck Surgery
Zip code
Address	1-1 Mukogawa, Nishinomiya, Hyogo Japan
TEL	0798456492
Email	msakaga@hyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoko Nishii
Organization	Hyogo College of Medicine
Division name	Depertment of Otolaryngology- Head and Neck Surgery
Zip code
Address	1-1 Mukogawa, Nishinomiya, Hyogo Japan
TEL	0798456492
Homepage URL
Email	tnami@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 12 Month 01 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
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	2017 Year 08 Month 01 Day
Date of IRB	2017 Year 08 Month 24 Day
Anticipated trial start date	2017 Year 08 Month 24 Day
Last follow-up date	2018 Year 08 Month 30 Day
Date of closure to data entry	2018 Year 10 Month 30 Day
Date trial data considered complete	2018 Year 10 Month 30 Day
Date analysis concluded	2019 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 11 Month 27 Day
Last modified on	2019 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039886