Clinical trial NCT03556215: Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
Official title: Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Eustachian Tube Dysfunction
Chronic Recurrent Otitis Media
Effusion After Tympanostomy
Keywords: otitis media with effusion
balloon tuboplasty
Eustachian tube
Eustachian tube dysfunction
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University Hospital Hradec Kralove
First posted: 2018-06-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional parallel randomized controlled prospective trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Otomicro(endo)scopy
timeFrame: 36 months
Secondary outcomes:
measure: Symptoms severity according to Visual Analogue Scale
timeFrame: 36 months
measure: ETDQ-7 questionnaire
timeFrame: 36 months
measure: Tympanometry
timeFrame: 36 months
measure: Audiometry
timeFrame: 36 months
measure: Tubomanometry
timeFrame: 36 months
measure: Possibility of Valsalva and Toynbee manoeuvre
timeFrame: 36 months
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
state: Hradec Králové Region
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Pavel Komínek, prof.,MD,Ph.D.,MBA
role: STUDY_CHAIR
affiliation: University Hospital Ostrava
name: Martin Formánek, MD
role: PRINCIPAL_INVESTIGATOR
References: