Randomized Controlled Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Otorhinolaryngol. Jul 2, 2025; 12(1): 109355
Published online Jul 2, 2025. doi: 10.5319/wjo.v12.i1.109355
Otitis media with effusion and hearing outcomes - Myringotomy vs myringotomy and tympanostomy: A comparative study
Abdul Basit, Sania Noor, Syed A Ahmad, Nimra Noor, Rafia Maryam, Abdul M Basil
Abdul Basit, Sania Noor, Syed A Ahmad, Nimra Noor, Department of Ear, nose and Throat, King Edward Medical University, Lahore 54000, Punjab, Pakistan
Rafia Maryam, Department of Ear, nose and Throat, Hamadan Medical University, Hamadan 6517838736, Hamadān, Iran
Abdul M Basil, Department of Medicine, Spinghar Medical University, Kabul 1001, Kābul, Afghanistan
Co-first authors: Abdul Basit and Sania Noor.
Author contributions: Ahmad SA contributed to study conception; Basit A contributed to literature review; Basit A, Noor S, Ahmad SA, Noor N, Maryam R, Basil AM contributed to write up and review.
Institutional review board statement: It was submitted to the Institutional Review Board for ethical approval. The committee approved the summary after thorough discussion at its meeting held on May 19, 2022, and felt it was appropriate.
Clinical trial registration statement: The trial was registered with PakCTRC on May 23, 2012, under registration number 1537397. This registration ensures that the trial is transparent and meets ethical standards for human clinical research. The registration record includes comprehensive details about the study design, objectives, methods, inclusion/exclusion criteria and outcome measures.
Informed consent statement: I have read and understood the information provided above. I have had the opportunity to ask questions and all my questions have been answered to my satisfaction. I voluntarily agree to participate in this study.
Conflict-of-interest statement: All authors declare that there are no conflicts of interest related to this manuscript. The authors have no financial or personal relationships with other people or organizations that could inappropriately influence (bias) their work. If any potential conflicts arise, they have been disclosed and appropriately managed in accordance with the journal's policies.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: Basic research and clinical research studies require a data sharing statement according to the guideline of data and reproducibility from COPE data and reproducibility from COPE. The data sharing statement will be provided in the title page, and will be presented in the following form: Technical appendix, statistical code, and dataset available from the corresponding author at Dryad repository, who will provide a permanent, citable and open-access home for the dataset.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Abdul M Basil, MD, Department of Medicine, Spinghar Medical University, 4th Alley, Char Rahe Qambar Kabul, Kabul 1001, Afghanistan. abdulmaboodbasil@outlook.com
Received: May 8, 2025
Revised: May 14, 2025
Accepted: June 11, 2025
Published online: July 2, 2025
Processing time: 55 Days and 11.6 Hours
Abstract
BACKGROUND

Otitis media with effusion (OME), glue ear, serous otitis media, or secretory otitis media is a common paediatric condition. Two widely used surgical interventions for OME are myringotomy alone and myringotomy with tympanostomy tube. While both procedures aim to improve hearing outcomes, the efficacy of these approaches has been a subject of ongoing research and debate.

AIM

To compare the efficacy of myringotomy alone and myringotomy with tympanostomy tube.

METHODS

In this comparative study, 66 patients diagnosed as OME meeting the inclusion criteria were selected via ear, nose and throat department. They were divided into two groups randomly, each of 33 patients. In the first group (Group A) myringotomy alone was performed while in the second group (Group B) myringotomy with tympanostomy tube placement was performed. We observed hearing outcome by pure tone audiogram (PTA) pre operatively. Patients were followed up and re-assessed in outdoor patient department at 4th week postoperatively again by PTA.

RESULTS

The mean age of the patients in Group A was 10.96 ± 2.76 SD but the mean age of the patients in Group B was 10.22 ± 2.73 SD (P = 0.1056). In Group A, males were 63.6% and females were 36.3%. Also in Group B, males were 63.6% and females were 36.3% (P = 1.0). In group A, post operative hearing gain using pure tone audiometry at one month was 20.45 ± 3.78 SD while in group B, post operative hearing gain using pure tone audiometry at one month was 23.84 ± 3.69 SD (P = 0.00005). However, ear discharge was noted in 3.03% cases in group A and 15.15% cases in group B (P = 0.035). By applying independent t-test, the P < 0.05 indicated that there is a significant association between Group B and hearing improvement at 4th week.

CONCLUSION

Our study concluded that myringotomy with tympanostomy tube seems to have better hearing results than myringotomy alone in treatment of OME.

Keywords: Hearing loss; Myringotomy; Tympanostomy; Otitis media with effusion

Core Tip: This comparative study shows that myringotomy with tympanostomy tube offers significantly better short-term hearing improvement in otitis media with effusion patients than myringotomy alone. However, it may carry a higher risk of postoperative ear discharge.