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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Middle ear diseases such as chronic otitis media, osteomyolitis otitis media, otosclerosis | |
Classification by specialty |
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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 |
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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. |
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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 |
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Age-upper limit |
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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 |
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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 |
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 | |
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 |
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Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Partially published |
URL releasing results | |
Results | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |