Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trialBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38210.827917.7C (Published 16 September 2004) Cite this as: BMJ 2004;329:651
- Birgit K van Staaij, general practitioner1,
- Emma H van den Akker, otorhinolaryngologist2,
- Maroeska M Rovers, clinical epidemiologist1,
- Gerrit Jan Hordijk, professor3,
- Arno W Hoes, professor1,
- Anne G M Schilder, otorhinolaryngologist ()2
- 1 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85060, 3508 AB Utrecht, Netherlands
- 2 Department of Otorhinolaryngology, Wilhelmina Children's Hospital, University Medical Center Utrecht, PO Box 85090, 3508 AB Utrecht, Netherlands
- 3 Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, 3584 CX Utrecht, Netherlands
- Correspondence to: A G M Schilder
- Accepted 6 July 2004
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 person 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 to two. 12 children had complications related to surgery.
Conclusion Adenotonsillectomy has no major clinical benefits over watchful waiting in children with mild symptoms of throat infections or adenotonsillar hypertrophy.
The participating hospitals and members of the executive steering committee are on bmj.com
We thank the participants and their parents; our colleagues and nurses in the participating hospitals; Nelly van Eden for secretarial support; Patrick Poels, Ward Videler, Charlotte van Krevel, and Wytske Richard for help with the conduct of the trial and recruitment of the patients; and Frank Leus for data management.
Contributors BKvS and EhvdA planned the study; collected, analysed, and interpreted the data; and wrote the paper equally. MMR analysed and interpreted the data. GJH contributed to the initial concept and design of the study and interpreted the data. AGMS and AWH designed, planned, and supervised the study and interpreted the data. The manuscript was prepared by BKvS and EHvdA and commented on by all authors. AGMS is guarantor.
Funding Dutch Health Care Insurance Board (OG-99-060).
Competing interests None declared.
Ethical approval This study was approved by the medical ethics committees of all participating hospitals.