Efficacy of Eustachian tube balloon dilatation combined with Tympanoplasty: Preliminary data of a randomized controlled trial

Introduction
Balloon Eustachian tuboplasty (BET) is applied for the treatment of Eustachian tube dysfunction (ETD) since 2010. In recent years studies supporting the use of BET in patients suffering from ETD have been published. Nevertheless, it is still unclear if BET provides an additional benefit in patients requiring tympanoplasty.

Material and methods
Patients with chronic inflammatory middle ear disease scheduled for tympanoplasty and with confirmed ETD were randomized to either tympanoplasty only or to an additional BET of the affected ear. Measurements performed on the preoperative day as well as after 2, 6 and 12 months included the subjective parameters Valsalva´s maneuver and "clicking sound when swallowing" and tubomanometry according to Estève (to generate the Eustachian tube score (ETS)) and air and bone conduction pure tone audiometry, speech audiometry, tympanometry, ear microscopy and further subjective tests including ETDQ7.

Results
Seventy-six patients were randomized. In the forty-six patients with complete data, the ETS in the tympanoplasty only group, improved from 1.74 + 1.57 to 4.17 + 2.37 and in the tympanoplasty plus BET group from 1.74 + 1.57 to 4.43 + 2.76 (p > 0.05 for treatment effect). The air bone gap (4PTA) improved from 26.1 + 13.1dB to 19.0 + 10.8dB and from 30.91 + 10.5dB to 20.1 + 9.0dB in the tympanoplasty and the tympanoplasty plus BET group, respectively (p > 0.05 for treatment effect).

Discussion
No additional benefit of BET was detected in patients with confirmed ETD, who received a tympanoplasty for chronic inflammatory middle ear disease. The indication for BET in addition to tympanoplasty should be given with caution. The observation warrants the conduction of a larger multicentric randomized controlled trial.

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