Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Eustachian Tube Dysfunction Chronic Recurrent Otitis Media Effusion After Tympanostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional parallel randomized controlled prospective trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking was used in the study

Study Groups

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Effusion, Eustachian tube dilatation device and 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

Group Type EXPERIMENTAL

Eustachian tube dilatation device

Intervention Type DEVICE

Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.

Myringotomy

Intervention Type PROCEDURE

Myringotomy will be performed using a standard procedure.

Effusion, 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)

Group Type EXPERIMENTAL

Eustachian tube dilatation device

Intervention Type DEVICE

Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.

No effusion, 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

Group Type EXPERIMENTAL

Eustachian tube dilatation device

Intervention Type DEVICE

Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.

Interventions

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Eustachian tube dilatation device

Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.

Intervention Type DEVICE

Myringotomy

Myringotomy will be performed using a standard procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No