Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
- Conditions
- Chronic Eustachian Tube DysfunctionChronic Recurrent Otitis MediaEffusion After Tympanostomy
- Interventions
- Device: Eustachian tube dilatation deviceProcedure: Myringotomy
- Registration Number
- NCT03556215
- Lead Sponsor
- University Hospital Ostrava
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Effusion, Eustachian tube dilatation device and myringotomy Eustachian tube dilatation device Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy Effusion, Eustachian tube dilatation device and myringotomy Myringotomy Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy Effusion, Eustachian tube dilatation device Eustachian tube dilatation device Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty only (no myringotomy) No effusion, Eustachian tube dilatation device Eustachian tube dilatation device Patients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy
- Primary Outcome Measures
Name Time Method Otomicro(endo)scopy 36 months Otomicro(endo)scopy will be used to assess the presence or absence of effusion.
- Secondary Outcome Measures
Name Time Method 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.
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.
Audiometry 36 months Hearing loss according to WHO classification (mild, moderate, severe).
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)
Trial Locations
- Locations (2)
University Hospital Hradec Králové
🇨🇿Hradec Králové, Hradec Králové Region, Czechia
University Hospital Ostrava
🇨🇿Ostrava, Moravian-Silesian Region, Czechia