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| ID | Type | Description | Link |
|---|---|---|---|
| MH CZ - DRO - FNOs/2016 | Other Grant/Funding Number | Ministry of Health of the Czech Republic |
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| Name | Class |
|---|---|
| University Hospital Hradec Kralove | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effusion, Eustachian tube dilatation device and myringotomy | Experimental | Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy |
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| Effusion, Eustachian tube dilatation device | Experimental | 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) |
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| No effusion, Eustachian tube dilatation device | Experimental | Patients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eustachian tube dilatation device | Device | Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Otomicro(endo)scopy | Otomicro(endo)scopy will be used to assess the presence or absence of effusion. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms severity according to Visual Analogue Scale | 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. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavel KomÃnek, prof.,MD,Ph.D.,MBA | University Hospital Ostrava | Study Chair |
| Martin Formánek, MD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Králové | Hradec Králové | Hradec Králové Region | 500 05 | Czechia | ||
| University Hospital Ostrava |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40008607 | Derived | Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2. |
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The investigators have not decided to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008876 | Middle Ear Ventilation |
| ID | Term |
|---|---|
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
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Interventional parallel randomized controlled prospective trial
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No masking was used in the study
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| Myringotomy | Procedure | Myringotomy will be performed using a standard procedure. |
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| ETDQ-7 questionnaire | 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. | 36 months |
| Tympanometry | Type of tympanometry curve (A, B, C) according to Joerger et al. | 36 months |
| Audiometry | Hearing loss according to WHO classification (mild, moderate, severe). | 36 months |
| Tubomanometry | Assessment of opening pressure in Eustachian tube in mmHg. | 36 months |
| Possibility of Valsalva and Toynbee manoeuvre | The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no) | 36 months |
| Ostrava |
| Moravian-Silesian Region |
| 708 52 |
| Czechia |