J Zirkler1, T Rahne1, C Lautenschläger2, R Honigmann1, S K Plontke3. 1. Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Martin-Luther-Universität Halle-Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Deutschland. 2. Institut für Medizinische Epidemiologie, Biometrie und Informatik, Martin-Luther-Universität Halle-Wittenberg, Halle (Saale), Deutschland. 3. Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Martin-Luther-Universität Halle-Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Deutschland. stefan.plontke@uk-halle.de.
Abstract
BACKGROUND: Eustachian tube dysfunction is considered a major contributor to chronic middle ear disease. In clinical case series, the results of balloon dilation (balloon Eustachian tuboplasty, BET) as a treatment for Eustachian tube dysfunction have been reported. OBJECTIVE: This study aims to analyze whether patients undergoing planned surgery for chronic middle ear disease would benefit from additional BET. METHODS: In a randomized controlled, patient and observer (not surgeon)-blind clinical study, 100 adult patients with planned surgery for chronic middle ear disease will be investigated. Patients will be randomized into two groups, one of which (50%) will receive additional BET of the affected side during the planned surgery. Eustachian tube function will be evaluated using the Valsalva maneuver and tubomanometry according to Estève, as well as on the basis of patient reports. Various scores will be used as outcome measures, including ETS-5 (Eustachian Tube Score 5), the extended version ETS-7, and the ETDQ-7 (Seven-Item Eustachian Tube Dysfunction Questionnaire). Follow-up is at 3, 6, and 12 months. RESULTS:From June to December 2015, 162 patients underwent microscopic ear surgery. Inclusion criteria were not fulfilled by 90 patients. Of the remaining 72 patients with chronic middle ear disease, 12 patients (17%) have been randomized so far, 28 (39%) did not exhibit Eustachian tube dysfunction, and 32 (44%) patients could not be included for other reasons. CONCLUSION: The rate of recruitment was lower than expected. Depending on the case number calculations for the patient groups identified in the study for whom BET might be particularly beneficial, multicenter studies in specific disease groups may follow.
RCT Entities:
BACKGROUND:Eustachian tube dysfunction is considered a major contributor to chronic middle ear disease. In clinical case series, the results of balloon dilation (balloon Eustachian tuboplasty, BET) as a treatment for Eustachian tube dysfunction have been reported. OBJECTIVE: This study aims to analyze whether patients undergoing planned surgery for chronic middle ear disease would benefit from additional BET. METHODS: In a randomized controlled, patient and observer (not surgeon)-blind clinical study, 100 adult patients with planned surgery for chronic middle ear disease will be investigated. Patients will be randomized into two groups, one of which (50%) will receive additional BET of the affected side during the planned surgery. Eustachian tube function will be evaluated using the Valsalva maneuver and tubomanometry according to Estève, as well as on the basis of patient reports. Various scores will be used as outcome measures, including ETS-5 (Eustachian Tube Score 5), the extended version ETS-7, and the ETDQ-7 (Seven-Item Eustachian Tube Dysfunction Questionnaire). Follow-up is at 3, 6, and 12 months. RESULTS: From June to December 2015, 162 patients underwent microscopic ear surgery. Inclusion criteria were not fulfilled by 90 patients. Of the remaining 72 patients with chronic middle ear disease, 12 patients (17%) have been randomized so far, 28 (39%) did not exhibit Eustachian tube dysfunction, and 32 (44%) patients could not be included for other reasons. CONCLUSION: The rate of recruitment was lower than expected. Depending on the case number calculations for the patient groups identified in the study for whom BET might be particularly beneficial, multicenter studies in specific disease groups may follow.