Objective: To assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy.
Design: Open, randomised controlled trial.
Setting: 21 general hospitals and three academic centres in the Netherlands.
Participants: 300 children aged 2-8 years requiring adenotonsillectomy.
Intervention: Adenotonsillectomy compared with watchful waiting.
Main outcome measures: Episodes of fever, throat infections, upper respiratory tract infections, and health related quality of life.
Results: During the median follow up period of 22 months, children in the adenotonsillectomy group had 2.97 episodes of fever per person year compared with 3.18 in the watchful waiting group (difference -0.21%, 95% confidence interval -0.54 to 0.12), 0.56 throat infections per year compared with 0.77 (-0.21, -0.36 to -0.06), and 5.47 upper respiratory tract infections per person year compared with 6.00 (-0.53, -0.97 to -0.08). No clinically relevant differences were found for health related quality of life. Adenotonsillectomy was more effective in children with a history of three to six throat infections than in those with none or two. 12 children had surgery related complications.
Conclusion: Adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy has no major clinical benefits over watchful waiting.