Randomized, controlled, single-blinded trial for the evaluation of balloon Eustachian tuboplasty in patients with chronic middle ear disease
Not Applicable
- Conditions
- H69.8Other specified disorders of Eustachian tube
- Registration Number
- DRKS00031807
- Lead Sponsor
- niversitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
planned middle ear surgery
- negative or difficult Valsalva maneuver
- Eustachian Tube Score = 5 pre-operatively
- chronic middle ear disease
Exclusion Criteria
- Status post radiation
- Cleft lip and palate
- Malformations
- effusion as only symptom of chonic otitis media
- Anatomy not allowing for balloon Eustachian tuboplasty
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the improvement of the Eustachian tube score (generated from the subjective symptoms clicking noise by swallowing and clicking noise by Valsalva, as well as the objectively measured results of tubomanometry) , which is determined preoperatively and after approximately 2, 6 and 12 months.
- Secondary Outcome Measures
Name Time Method - Subjective improvement of the Valsalva-maneuver according to the patient<br>- subjective Patient satisfaction with respect to the Eustachian tube function<br>- Differences in air-bone gap <br>- Improvement of the Valsalva-maneuver in otoskopy