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Endoscopic single versus double flap tympanoplasty: a randomized clinical trial

European Archives of Oto-Rhino-Laryngology volume 278, pages 1395–1401 (2021)Cite this article

A Letter to the Editor to this article was published on 09 November 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.

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Funding

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Affiliations

  1. Department of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Mansoura University, El-Gomhoria Street, Dakahlia Governorate, Mansoura, 35516, Egypt

    Noha Ahmed El-Kholy, Mohammed Abdelbadie Salem & Abdelwahab Mohamed Rakha

Authors
  1. Noha Ahmed El-Kholy
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  2. Mohammed Abdelbadie Salem
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  3. Abdelwahab Mohamed Rakha
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Contributions

Noha Ahmed El-Kholy: collection, analysis, interpretation of data, drafting, revising and final approval of the manuscript. Mohammed Abdelbadie Salem: conception and design of the study, performing the surgical intervention, interpretation of data, revising and final approval of the manuscript. Abdelwahab Mohamed Rakha: design and supervision of the study, interpretation of data, revising and final approval of the manuscript.

Corresponding author

Correspondence to Noha Ahmed El-Kholy.

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None to declare.

Ethical approval

Approval of institutional review board of Mansoura University, Faculty of Medicine (code: MS/17.07.100) was obtained. Consolidated Standards of Reporting Trials (CONSORT) statement was adhered to with registration at the Clinical Trials Registry (NCT03922295).

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All patients signed a written informed consent prior to surgery.

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Cite this article

El-Kholy, N.A., Salem, M.A. & Rakha, A.M. Endoscopic single versus double flap tympanoplasty: a randomized clinical trial. Eur Arch Otorhinolaryngol 278, 1395–1401 (2021). https://doi.org/10.1007/s00405-020-06212-3

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  • DOI: https://doi.org/10.1007/s00405-020-06212-3

Keywords

  • Endoscopic tympanoplasty
  • Tympanic membrane perforation
  • Anterior tab
  • Total and subtotal perforations