H69.8
Conditions
Interventions
Group 1: In addition to the planned tympanoplasty the blinded patient recieves a balloon Eustachian tuboplasty on the affected side. Eustachian ballon tuboplasty is performed during the anesthesia fo
Sponsors
Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - planned middle ear surgery - negative or difficult Valsalva maneuver - Eustachian Tube Score = 5 pre-operatively - chronic middle ear disease
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - Subjective improvement of the Valsalva-maneuver according to the patient - subjective Patient satisfaction with respect to the Eustachian tube function - Differences in air-bone gap - Improvement of the Valsalva-maneuver in otoskopy | — |
Countries
Germany
Contacts
Public ContactStefan Plontke
Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
Outcome results
None listed