Endoscopic single versus double flap tympanoplasty: a randomized clinical trial
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OTOLOGY
Endoscopic single versus double flap tympanoplasty: a randomized clinical trial Noha Ahmed El‑Kholy1 · Mohammed Abdelbadie Salem1 · Abdelwahab Mohamed Rakha1 Received: 18 April 2020 / Accepted: 14 July 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract 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. Keywords Endoscopic tympanoplasty · Tympanic membrane perforation · Anterior tab · Total and subtotal perforations
Introduction Tympanoplasty is the surgery of choice for chronic suppurative otitis media (CSOM) [1]. It is used for tympanic membrane (TM) perforation repair and possible ossiculoplasty aiming for elimination of disease and restoration of function [2]. Function restoration requires a healthy intact TM which is crucial for normal hearing and preservation of middle and * Noha Ahmed El‑Kholy [email protected] 1
Department of Otorhinolaryngology‑Head and Neck Surgery, Faculty of Medicine, Mansoura University, El‑Gomhoria Street, Dakahlia Governorate, Mansoura 35516, Egypt
inner ear structures [3]. Regardless of the technique used, the surgical target remai
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