Endoscopic Ear Surgery for Perilymph Fistula
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0009005
- Lead Sponsor
- Soonchunhyang University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
? Adults aged 19 and older
? Those who have symptoms of sensorineural hearing loss accompanied by dizziness within 3 months after barotrauma
? Normal eardrum findings
? Spontaneous nystagmus/positional nystagmus or positive fistula test
? Subjects who have given written consent in the consent form
? Those with posterior labyrinth lesions or central lesions
? Chronic otitis media, recurrent otitis media, tympanic membrane perforation, acute inflammatory disease, conductive and sudden sensetive those diagnosed with and receiving treatment for hearing loss, objective tinnitus, or somatic tinnitus
? Antidepressants for neuropsychiatric diseases such as depression, anxiety, sleep disorders, and convulsive disorders.
People taking drugs that affect the neuropsychiatric system, such as anti-anxiety drugs
? Those who have received drugs (steroids including oral/injected drugs, ototoxic drugs, etc.), surgery, or rehabilitation treatment that may affect hearing and dizziness function within 4 weeks prior to screening
? Those in whom external ear canal surgery is not possible due to abnormal structure of the external auditory canal
? Those who participated in another clinical (human application) test within 4 weeks prior to participating in this human application test
? If the person does not want to, does not fill out the consent form, or is unable to understand the contents of the consent form (illiterate, foreigner, etc.)
? In addition to the above matters, subjects who are judged by the clinical trial director to be unable to comply with the test requirements or who are deemed unsuitable by other doctors.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Fistula confirmation (diagnosis)> The primary endpoint is a comparison of the fistula confirmation rate (fistula diagnosis rate) of perilymph fluid outflow under a microscope and under an endoscope.
- Secondary Outcome Measures
Name Time Method (1) Degree of improvement in pure tone hearing test 1 month after surgery compared to before surgery;(2) Degree of improvement in dizziness (DHI, NPRS) 1 month after surgery compared to before surgery;(3) Nystagmus disappearance rate 1 month after surgery compared to before surgery;(4) Microscope Concordance rate between fistula confirmation and endoscopic fistula confirmation;(5) Comparison of results between microscopic-only fistula confirmation and microscopic and endoscopic fistula confirmation groups;(6) Comparison of fistula confirmation rates between groups A and B