UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035018 |
|---|---|
| Receipt number | R000039886 |
| Scientific Title | The changes of taste and somatosensory function after middle ear surgery |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2019/07/02 15:48:45 |
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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
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
tnami@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039886
