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Erschienen in:
20.07.2020 | Otology
Endoscopic single versus double flap tympanoplasty: a randomized clinical trial
Erschienen in: European Archives of Oto-Rhino-Laryngology | Ausgabe 5/2021
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Objective
This study aims to compare the results of endoscopic over–underlay tympanoplasty, single flap technique, with endoscopic over–underlay tympanoplasty combined with an anterior tab, double flap technique, in repair of the challenging total and subtotal tympanic membrane perforations with inadequate anterior remnant. This is to determine whether highly adequate visualization at the anterior meatal angle area offered by endoscopy can eliminate the need for anterior tab reinforcement.
Subjects and methods
A prospective randomized single-blinded study involving 104 patients with total or subtotal tympanic membrane perforations was conducted. Patients were randomized into two groups: 52 with endoscopic single flap tympanoplasty, first group, and 52 with endoscopic double flap tympanoplasty, second group, between August 2017 and February 2019. The main outcome is graft take rate. Secondary outcomes include hearing results, pain score assessment, operative time and postoperative complications.
Results
Graft take rates were 94% and 98% for the first and second groups, respectively (P value = 0.307). Significant improvement was achieved in total air–bone gap from 21.45 ± 5.37 and 23.1 ± 4.47 preoperatively to 6.4 ± 5.46 and 6.15 ± 3.57 postoperatively for the first and second groups, respectively. Pain scores were not significantly different between the two groups. Mean operative time was significantly longer in the second group (P value = 0.010). There was no reported lateralization or anterior blunting in both groups.
Conclusion
In repair of total and subtotal tympanic membrane perforations with inadequate anterior remnant, endoscopic enrollment provides excellent visualization and good manipulation at the anterior meatal angle area with favorable results, eliminating the need for adding an anterior tab and alleviating the burden of longer operative time.
Clinical trial registry
ClinicalTrials.gov (NCT03922295) “retrospectively registered” at 18/4/2019.