JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Comparison between myringotomy and tympanostomy tubes in combination with adenoidectomy in 3-7-year-old children with otitis media with effusion.

The specific aim of this study was to compare, by means of a randomized clinical trial, the efficacy between the two surgical combinations - adenoidectomy with myringotomy and tympanostomy (A+T) and adenoidectomy with myringotomy (A+M) - in reducing middle ear disease in children with otitis media with effusion (OME). Seventy-eight 3-7-year-old patients (156 ears) with a history of bilateral middle ear effusion for at least 3 months were randomly assigned to either A+T or A+M. Hearing threshold levels, recurrence rate of the effusion and episodes of acute otitis media (AOM) and otorrhea were evaluated for a follow-up period of 1 year. Audiometry testing showed that there was no statistically significant difference in the hearing loss levels of both groups during the whole follow-up period. Free of AOM episodes were 72% of the patients in the A+T group and 75% of those in the A+M group. None of the patients with A+M had episodes with otorrhea which contrasted with the 40% occurrence rate in the A+T group. During the follow-up period we documented a 10% recurrence rate of OME in the A+T group and 14% recurrence rate in the A+M group. Overall our data suggests that the insertion of tympanostomy tubes in association with adenoidectomy provides no additional benefit to adenoidectomy in association with myringotomy alone in terms of hearing loss or AOM episode occurrences in patients with bilateral otitis media with effusion. Furthermore no relationship was found between the choice of operative intervention and the recurrence rate of OME despite the slightly greater relative risk in the A+M group.

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