Effectiveness of adenotonsillectomy in children with mild symptoms
of throat infections or adenotonsillar hypertrophy: open,
randomised controlled trial
Birgit K van Staaij, Emma H van den Akker, Maroeska M Rovers, Gerrit Jan Hordijk, Arno W Hoes, Anne G M
Objective To assess the effectiveness of adenotonsillectomy in
children with mild symptoms of throat infections or
Design Open, randomised controlled trial.
Setting 21 general hospitals and three academic centres in the
Participants 300 children aged 2-8 years requiring
Intervention Adenotonsillectomy compared with watchful
Main outcome measures Episodes of fever, throat infections,
upper respiratory tract infections, and health related quality of
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.
Tonsillectomy,with or without adenoidectomy,is a common pro-
cedure in children in western countries, yet the indications for
surgery remain uncertain, as reflected by the large variation in
surgical rates across countries. In 1998, for example, 115 per
10 000 children underwent adenotonsillectomy in the Nether-
lands,65 per 10 000 in England,and 50 per 10 000 in the United
We previously reported that in the Netherlands 35% of chil-
dren underwent adenotonsillectomy for frequent throat infec-
tions (seven or more a year) or obstructive sleep apnoea, and the
remainder for less frequent throat infections,mild adenotonsillar
hypertrophy, or indications such as upper respiratory tract infec-
tions.2Although frequent throat infections and obstructive sleep
apnoea are considered adequate indications for adenotonsillec-
tomy in children,3–8evidence for the benefits of surgery in
children with milder symptoms is lacking.2 9–12We carried out a
randomised controlled trial to assess the effectiveness of
adenotonsillectomy in children with mild symptoms of throat
infections or adenotonsillar hypertrophy.
Participants and methods
We carried out an open,multicentre,randomised controlled trial
between March 2000 and February 2003. Otorhinolaryngolo-
gists from 21 general hospitals and three academic centres in the
Netherlands were asked to complete a questionnaire on all their
patients aged 2 to 8 years with indications for adenotonsillec-
tomy according to current medical practice. They were asked to
give the indication they considered most important for surgery:
recurrent throat infections (three or more a year) or other indi-
cations such as obstructive problems or recurrent upper respira-
tory tract infections.
We excluded children with a history of seven or more throat
infections in the preceding year, with five or more in each of the
previous two years, or with three or more in each of the previous
three years (Paradise criteria),3and children with suspected
obstructive sleep apnoea—that is, Brouillette’s obstructive sleep
apnoea score of more than 3.5.13Other exclusion criteria were
Down’s syndrome, craniofacial malformations such as cleft
palate, and immunodeficiency, other than deficiencies of IgA or
Children whose parents gave informed consent were randomly
assigned to either adenotonsillectomy within six weeks or watch-
ful waiting. Randomisation was by a computer generated list of
four numbers in each block and fixed blocks within each hospi-
When children were entered in the study, the study doctors
completed a disease specific questionnaire on the basis of infor-
mation provided by the parents. This elicited information on the
number of throat infections and upper respiratory tract
infections experienced by the children in the previous year;
obstructive symptoms during sleep13; eating patterns; previous
ear, nose, and throat operations; and risk factors for upper respi-
ratory tract infections.
The participating hospitals and members of the executive steering commit-
tee are on bmj.com
Cite this article as: BMJ, doi:10.1136/bmj.38210.827917.7C (published 10 September 2004)
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page 1 of 6
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(Accepted 6 July 2004)
Julius Center for Health Sciences and Primary Care, University Medical Center
Utrecht, PO Box 85060, 3508 AB Utrecht, Netherlands
Birgit K van Staaij general practitioner
Maroeska M Rovers clinical epidemiologist
Arno W Hoes professor
Department of Otorhinolaryngology, Wilhelmina Children’s Hospital, University
Medical Center Utrecht, PO Box 85090, 3508 AB Utrecht, Netherlands
Emma H van den Akker otorhinolaryngologist
Anne G M Schilder otorhinolaryngologist
Department of Otorhinolaryngology, Head and Neck Surgery, University Medical
Center Utrecht, 3584 CX Utrecht, Netherlands
Gerrit Jan Hordijk professor
Correspondence to: A G M Schilder A.Schilder@wkz.azu.nl
page 6 of 6
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