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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035018
Receipt No. R000039886
Official scientific title of the study The changes of taste and somatosensory function after middle ear surgery
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/27

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Basic information
Official scientific title of the study The changes of taste and somatosensory function after middle ear surgery
Title of the study (Brief title) 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 Masafumi Sakagami
Organization Hyogo College of Medicine
Division name Department of Otolaryngology-Head and Neck Surgery
Address 1-1 Mukogawa, Nishinomiya, Hyogo Japan
TEL 0798456492
Email msakaga@hyo-med.ac.jp

Public contact
Name of contact person Tomoko Nishii
Organization Hyogo College of Medicine
Division name Depertment of Otolaryngology- Head and Neck Surgery
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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 01 Day
Anticipated trial start date
2017 Year 08 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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