Chronic otitis media with effusion and adeno-tonsillectomy--a prospective randomized controlled study.

Otitis media with effusion (OME) is one of the commonest, chronic otological conditions of early childhood. There is considerable variation in management in different centres throughout the world. Surgical treatment of the ears, adenoids, tonsils and sinuses is frequently employed and the condition constitutes one of the main indications for adenoidectomy and to a lesser extent for tonsillectomy. To date no randomized prospective, adequately controlled study has demonstrated the effect of these operations on established OME. The present work reports the results at 6 weeks, 3 months, 6 months, 9 months and one year following adenoidectomy and adenotonsillectomy performed randomly and prospectively with a controlled no-surgery group on a cohort of 103 children with established OME, unresponsive to medical treatment. Following adenoidectomy the rate of resolution of OME increases from 39% at 6 weeks, to 72% at one year; and following adeno-tonsillectomy the rate increases from 59% at 6 weeks to 62% at one year. In the no-surgery group the rate increases from 16% at 6 weeks to 26% at one year. Compared with the no-surgery group the effect of adenoidectomy alone at one year is highly significant (P less than or equal to 0.001) and similarly the effect of adenotonsillectomy is significant (P less than or equal to 0.01). However, there is no increased benefit from the addition of tonsillectomy compared with adenoidectomy alone. Thus adenoidectomy resolves established OME in 36-46% of cases for up to 12 months.

RCT Entities:   Population Interventions Outcomes