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Objective-To measure the time to spontaneous resolution of severe chronic otitis media with effusion (glue ear) in children and study the effects of adenoidectomy, adenotonsillectomy, and ventilation tubes (grommets).Design-Randomised controlled study over 12years. Setting-Paediatric otorhinolaryngology clinics and in-patient unit.Subjects-228 children aged 2-9 years with pronounced hearing loss from glue ear and persistent bilateral middle ear effusions confirmed on three occasions over three months.Interventions-Children were randomly allocated to adenotonsillectomy, adenoidectomy, or neither procedure. In all groups a Shepard type ventilation tube was inserted in one randomly chosen ear. Follow up was annually for five years and then less often for up to seven years four months. For analysis the two operated groups were combined.Main outcome measures-Otoscopic clearance of fluid, change in tympanogram, and improvement in mean audiometric hearing threshold.Results-Survival analysis showed appreciable otoscopic and tympanometric resolution of fluid with ventilation tubes alone and adenoidectomy alone compared with no surgery. Further improvement was seen after combination ofboth treatments.Mean audiometric hearing thresholds improved with fluid resolution. Resolution was delayed in younger children and in those whose parents smoked, irrespective of treatment. Whereas a single insertion of a Shepard tube resolved the glue for a mean (SD) period of 9.5 (5.2) months, the effect of adenoidectomy was sustained throughout follow up.Conclusions-Treatment of glue ear considerably shortened the time to fluid resolution, combined adenoidectomy and tube insertion being better than either procedure alone. Resolution was longer in younger children and those whose parent(s) smoked, irrespective oftreatment.

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This trial was designed to compare early surgery with watchful waiting for persistent bilateral otitis media with effusion (OME) in terms of hearing loss and behavioural problems in pre-school children. A randomised controlled trial compared the effects of early treatment with ventilation tubes versus watchful waiting for 9 months. Results were analysed by intention-to-treat. One hundred and eighty-two pre-school children (date of birth between 1 April 1991 and 31 December 1992), mean age of 2.9 years (SD 0.85) with at least a 3-month history of bilateral OME and hearing loss of greater than 25 dB were treated in Bristol Children's Hospital between November 1993 and January 1996. Bilateral ventilation tubes were inserted within 6 weeks of randomisation or within 6 weeks of reassessment after 9 months of watchful waiting, with a final assessment at 18 months. The main outcome measures were behavioural problems, measured by the Richman Behaviour Checklist, and hearing loss at 4000 Hz in the better hearing ear. Early surgical intervention significantly reduced behavioural problems by 17% (95% CI, 2% - 33%). This difference was largely mediated by concurrent hearing loss. After 18 months, there was no longer a significant difference (95% Cl, -19% to +10%). However, the majority (85%) of the Watchful Waiting group had required surgery and 22% of all children still had behavioural problems.