Chronic Eustachian Tube Dysfunction, Chronic Recurrent Otitis Media, Effusion After Tympanostomy
Conditions
Keywords
otitis media with effusion, balloon tuboplasty, Eustachian tube, Eustachian tube dysfunction
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEustachian tube dilatation device
Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.
PROCEDUREMyringotomy
Myringotomy will be performed using a standard procedure.
Sponsors
University Hospital Hradec Kralove
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking was used in the study
Intervention model description
Interventional parallel randomized controlled prospective trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy
Exclusion criteria
* anatomic obstruction in nasopharynx * nasopharyngeal cancer * head and neck cancer * other middle ear surgery except for myringotomy or tympanostomy * chronic suppurative otitis media * patients who could not undergo general anesthesia * patients who did not give consent to be included in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Otomicro(endo)scopy | 36 months | Otomicro(endo)scopy will be used to assess the presence or absence of effusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ETDQ-7 questionnaire | 36 months | 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. |
| Tympanometry | 36 months | Type of tympanometry curve (A, B, C) according to Joerger et al. |
| Symptoms severity according to Visual Analogue Scale | 36 months | 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. |
| Tubomanometry | 36 months | Assessment of opening pressure in Eustachian tube in mmHg. |
| Possibility of Valsalva and Toynbee manoeuvre | 36 months | The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no) |
| Audiometry | 36 months | Hearing loss according to WHO classification (mild, moderate, severe). |
Countries
Czechia
Outcome results
None listed