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

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d5154 (Published 06 September 2011) Cite this as: BMJ 2011;343:d5154
  1. M T A van den Aardweg, PhD student and registrar in otorhinolaryngology1,
  2. C W B Boonacker, PhD student and clinical epidemiologist2,
  3. M M Rovers, associate professor of clinical epidemiology12,
  4. A W Hoes, professor of clinical epidemiology and general practice2,
  5. A G M Schilder, professor of paediatric otorhinolaryngology; ear, nose, and throat surgeon; and clinical epidemiologist12
  1. 1Department of Otorhinolaryngology, University Medical Centre Utrecht, Netherlands
  2. 2Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht
  1. Correspondence to: A G M Schilder, Department of Otorhinolaryngology, University Medical Centre Utrecht, Wilhelmina Children’s Hospital, HP KE 04.140.5, PO Box 85090, 3590 AB Utrecht, Netherlands A.Schilder{at}umcutrecht.nl
  • Accepted 27 June 2011

Abstract

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.

Footnotes

  • We thank the participants and their parents; Nelly van Eden for secretarial support, Nicole Boekema for data management, and Rolf Groenwold for assistance with the bootstrap analysis. We also thank our colleagues at the participating hospitals: Flevoziekenhuis Almere, Meander Medisch Centrum Amersfoort, Gelre Ziekenhuis Apeldoorn and Zutphen, Wilhelmina Ziekenhuis Assen, Albert Schweitzer Ziekenhuis Dordrecht, Universitair Medisch Centrum Groningen, Diakonessenhuis Meppel, St. Antonius Ziekenhuis Nieuwegein, Vlietland Ziekenhuis Schiedam, MESOS Medisch Centrum Utrecht and the Universitair Medisch Centrum Utrecht. Finally we thank the members of the executive steering committee: E H van den Akker, M J M Bonten, K Fischer, E A M Sanders, and R van Weissenbruch.

  • Contributors: MTAvdA and CWBB collected, analysed, and interpreted the data, and wrote the paper. MMR designed, planned, and supervised the study, analysed and interpreted the data. AGMS and AWH designed, planned, and supervised the study and interpreted the data. The manuscript was prepared by MTAvdA and CWBB and commented on by all authors. AGMS is guarantor.

  • Funding: This study was funded by ZonMw—the Netherlands Organisation for Health Research and Development, healthcare efficiency research programme, subprogramme effects and costs 2007 No 80-007022-98-07901. The funder had no role in the study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. All authors were independent from the funder and had access to all the data.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. AGMS and MMR have participated in workshops and educational activities on otitis media organised by GlaxoSmithKline and have received a grant from GlaxoSmithKline for a study on the microbiology of otitis media in 2009.

  • Ethical approval: This study was approved by the medical ethics committees of the University Medical Centre Utrecht and all participating hospitals and was monitored according to Good Clinical Practice. Informed consent was obtained from all participants.

  • Data sharing: Statistical code and dataset are available from the corresponding author. Consent for data sharing was not obtained from participants, but the presented data are anonymised and risk of identification is low.

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