The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group. Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.
The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group. Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. The otomicro(endo)scopy, symptoms severity according to VAS (Visual Analogue Pain Scale), ETDQ-7 (Eustachian Tube Dysfunction Questionnaire) questionnaire, tympanometry, audiometry and the possibility of Valsalva and Toynbee maneuver will be used to evaluate the effect of balloon ET dilatation. Only patients with standard treatment failure will be included in the study. Tuboplasty with and without myringotomy will be performed (and compared) in patients with chronic otitis media with effusion. Subgroups will be compared in order to find patients who could profit from the treatments the most.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.
Myringotomy will be performed using a standard procedure.
University Hospital Hradec Králové
Hradec Králové, Hradec Králové Region, Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Otomicro(endo)scopy
Otomicro(endo)scopy will be used to assess the presence or absence of effusion.
Time frame: 36 months
Symptoms severity according to Visual Analogue Scale
Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Time frame: 36 months
ETDQ-7 questionnaire
The patients will be asked to fill-in the Eustachian Tube Dysfunction Questionnaire in order to assess the symptoms of Eustachian Tube Dysfunction (ETD). The ETDQ-7 is a valid and reliable symptom score for use in adult patients with ETD. The ETDQ-7 tool consists of seven items with a scale of graduated responses ranging from 1 to 7, with "1" corresponding to the absence of the suggested symptom and "7", to maximum symptom severity.
Time frame: 36 months
Tympanometry
Type of tympanometry curve (A, B, C) according to Joerger et al.
Time frame: 36 months
Audiometry
Hearing loss according to WHO classification (mild, moderate, severe).
Time frame: 36 months
Tubomanometry
Assessment of opening pressure in Eustachian tube in mmHg.
Time frame: 36 months
Possibility of Valsalva and Toynbee manoeuvre
The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no)
Time frame: 36 months
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