OBJECTIVE: To determine the effects of adenotonsillectomy as compared with watchful waiting on the middle ear status of children. STUDY DESIGN: Randomized controlled trial. METHODS: We recruited 300 children between 2 and 8 years of age who were selected for adenotonsillectomy according to current medical practice. Excluded from the trial were children with very frequent throat infections (more than 6 per year) or obstructive sleep apnea. Participants were randomly assigned to either adenotonsillectomy or watchful waiting. Main outcome measure was the percentage of children with unilateral or bilateral otitis media diagnosed at the scheduled follow-up visits according to an algorithm combining tympanometry and otoscopy. RESULTS: The percentages of children in the adenotonsillectomy and watchful waiting group diagnosed with otitis media at baseline and at 3, 6, 12, 18, and 24 months were 27.7 versus 30.5, 16.8 versus 25.2, 18.3 versus 21.2, 12.3 versus 15.2, 17.6 versus 15.5, and 14.7 versus 10.3%, respectively (P < .10). In the subgroup of children selected for adenotonsillectomy predominantly because of recurrent or persistent otitis media, hearing loss, or recurrent upper respiratory tract infections (n = 111) and in the subgroup of children diagnosed with otitis media at inclusion (n = 82), the occurrence of otitis media did not differ significantly between the adenotonsillectomy and watchful waiting group during the entire follow-up period. CONCLUSION: We conclude that in a large proportion of children selected for adenotonsillectomy according to current medical practice, including those with otitis media or related complaints, no beneficial effect of adenotonsillectomy on middle ear status is to be expected.
RCT Entities:
OBJECTIVE: To determine the effects of adenotonsillectomy as compared with watchful waiting on the middle ear status of children. STUDY DESIGN: Randomized controlled trial. METHODS: We recruited 300 children between 2 and 8 years of age who were selected for adenotonsillectomy according to current medical practice. Excluded from the trial were children with very frequent throat infections (more than 6 per year) or obstructive sleep apnea. Participants were randomly assigned to either adenotonsillectomy or watchful waiting. Main outcome measure was the percentage of children with unilateral or bilateral otitis media diagnosed at the scheduled follow-up visits according to an algorithm combining tympanometry and otoscopy. RESULTS: The percentages of children in the adenotonsillectomy and watchful waiting group diagnosed with otitis media at baseline and at 3, 6, 12, 18, and 24 months were 27.7 versus 30.5, 16.8 versus 25.2, 18.3 versus 21.2, 12.3 versus 15.2, 17.6 versus 15.5, and 14.7 versus 10.3%, respectively (P < .10). In the subgroup of children selected for adenotonsillectomy predominantly because of recurrent or persistent otitis media, hearing loss, or recurrent upper respiratory tract infections (n = 111) and in the subgroup of children diagnosed with otitis media at inclusion (n = 82), the occurrence of otitis media did not differ significantly between the adenotonsillectomy and watchful waiting group during the entire follow-up period. CONCLUSION: We conclude that in a large proportion of children selected for adenotonsillectomy according to current medical practice, including those with otitis media or related complaints, no beneficial effect of adenotonsillectomy on middle ear status is to be expected.
Authors: G Motta; D Casolino; B Cassiano; S Conticello; E Esposito; F Galletti; V Galli; G Larotonda; P Laudadio; N Mansi; E Mevio; E Mira; G Motta; A Rinaldi Ceroni; V Tarantino; P Tavormina; C Vicini; S Motta; S Aversa; F Berni Canani; V Cappello; P Carra; D Cifarelli; G Cinquegrana; E Consolo; C Ondolo; G Ripa; G Romano Journal: Acta Otorhinolaryngol Ital Date: 2008-02 Impact factor: 2.124