Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
Condition: Chronic Eustachian Tube Dysfunction; Chronic Recurrent Otitis Media; Effusion After Tympanostomy
MeSH terms: Otitis; Otitis Media
Study type: Interventional

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.
    

Intervention name(s): Eustachian tube dilatation device; Myringotomy
Intervention type(s): Device; Procedure
Intervention description(s): Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.; Myringotomy will be performed using a standard procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional parallel randomized controlled prospective trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: otitis media with effusion; balloon tuboplasty; Eustachian tube; Eustachian tube dysfunction