Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial

OBJECTIVE To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. DESIGN Open randomised controlled trial. SETTING 11 general hospitals and two academic centres. PARTICIPANTS 111 children aged 1-6 with recurrent upper respiratory tract infections selected for adenoidectomy. INTERVENTION A strategy of immediate adenoidectomy with or without myringotomy or a strategy of initial watchful waiting. Main outcome measure Primary outcome measure: number of upper respiratory tract infections per person year calculated from data obtained during the total follow-up (maximum 24 months). SECONDARY OUTCOME MEASURES days with upper respiratory tract infection per person year, middle ear complaints with fever in episodes and days, days with fever, prevalence of upper respiratory tract infections, and health related quality of life. RESULTS During the median follow-up of 24 months, there were 7.91 episodes of upper respiratory tract infections per person year in the adenoidectomy group and 7.84 in the watchful waiting group (difference in incidence rate 0.07, 95% confidence interval -0.70 to 0.85). No relevant differences were found for days of upper respiratory tract infections and middle ear complaints with fever in episodes and days, nor for health related quality of life. The prevalence of upper respiratory tract infections decreased over time in both groups. Children in the adenoidectomy group had significantly more days with fever than the children in the watchful waiting group. Two children had complications related to surgery. CONCLUSION In children selected for adenoidectomy for recurrent upper respiratory tract infections, a strategy of immediate surgery confers no clinical benefits over a strategy of initial watchful waiting. Trial registration Dutch Trial Register NTR968: ISRCTN03720485.