Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Eustachian Tube Dysfunction
- Sponsor
- University Hospital Ostrava
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Otomicro(endo)scopy
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Otomicro(endo)scopy
Time Frame: 36 months
Otomicro(endo)scopy will be used to assess the presence or absence of effusion.
Secondary Outcomes
- Symptoms severity according to Visual Analogue Scale(36 months)
- ETDQ-7 questionnaire(36 months)
- Tympanometry(36 months)
- Audiometry(36 months)
- Tubomanometry(36 months)
- Possibility of Valsalva and Toynbee manoeuvre(36 months)