Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial [with commentary by P Little]

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85060, 3508 AB Utrecht, Netherlands.
BMJ (online) (Impact Factor: 17.45). 10/2004; 329(7467):651. DOI: 10.1136/bmj.38210.827917.7C
Source: PubMed


To assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy.
Open, randomised controlled trial.
21 general hospitals and three academic centres in the Netherlands.
300 children aged 2-8 years requiring adenotonsillectomy.
Adenotonsillectomy compared with watchful waiting.
Episodes of fever, throat infections, upper respiratory tract infections, and health related quality of life.
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.
Adenotonsillectomy has no major clinical benefits over watchful waiting in children with mild symptoms of throat infections or adenotonsillar hypertrophy.

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    • "The investigations of Paradise et al. [9], which were followed by subsequent studies by the same group [11] and by those of other researchers [12,13], were undoubtedly essential in this topic. However, several authors have raised objections to these studies [14-16], pointing out the possibility of bias in the investigation technique and the scarse acknowledgement of relations existing between the different pathological conditions related to adeno-tonsillar disease [17-20]. "
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    ABSTRACT: Background Several guidelines on adeno-tonsillar disease have been proposed in recent years and some discrepancies in relation both to clinical manifestations and indications for surgical treatment have emerged. The aim of the study was to verify what influence (adeno)-tonsillectomy guidelines have had on the clinical behaviour of ENT specialists in Italy. Our study is a retrospective and multi-centre case series with chart review. Methods The survey involved 14,770 children, aged between the ages of 2 and 11, who had undergone adeno-tonsillar surgery between 2002 and 2008 in fourteen Italian tertiary and secondary referral centres. Anova test was used for the statistical analysis, assuming p < 0.05 as the minimum statistical significance value. Results The frequency of adeno-tonsillar surgeries did not change significantly (p>0.05) during the study period and following the Italian policy document publication. Overall, adeno-tonsillectomy was the most frequent intervention (64.1%), followed by adenoidectomy (31.1%) and tonsillectomy (4.8%). The indications for surgery did not change significantly for each of the operations (p>0.05), with the exception of adeno-tonsillectomy in case of feverish episodes due to acute recurrent tonsillitis ≥ 5 without nasal obstruction (decreased p= 0.010) , even when the feverish episodes due to acute recurrent tonsillitis were < 5 over the last year. Nasal obstruction was associated with feverish episodes due to acute recurrent tonsillitis in 65.2% of operated cases, while otitis media had been diagnosed in 43.3% of the patients studied. Conclusions The recommendations first developed in Italy in a 2003 policy document and then resumed in guidelines in 2008, were not implemented by ENT units involved in the survey. The study highlights the fact that the indications for adeno-tonsillar operations are based on the overall clinical presentation (comorbidity) rather than on a single symptom. Guidelines are necessary to give coherent recommendations based on both the findings obtained through randomized controlled trials and the data collected from observational studies.
    Full-text · Article · Jan 2013 · BMC Ear Nose and Throat Disorders
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    • "Studies of established routines can present an ethical dilemma when selecting patients for different treatment modalities. These studies can also be difficult to perform for practical reasons, as shown in a study by van Staaij et al., where there was a cross-over by 41% of the patients between the study and the control groups [3]. Studies using data in large quality registries can be an attractive alternative [4,5]. "
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    ABSTRACT: Patients operated with tonsillar surgery report a high degree of symptom relief 6 months after surgery. The purpose of this study was to analyze symptom relief 6 months after tonsil surgery in relation to age, indication, surgical procedure, primary bleeding and unplanned postoperative visits. The National Tonsil Surgery Register in Sweden offers data from 54,696 patients registered during 1997-2008. This was a prospective assessment by questionnaire. Data were collected using three questionnaires, two completed by professionals and one 6 months postoperatively by the parents/patients. Among 54,696 patients, the most common surgical indications were obstruction (49.7%), followed by recurrent tonsillitis (35.2%). Symptom relief 6 months after surgery was high in all indication groups (>92%), and highest for patients operated on the indication peritonsillitis (>98%). The indications obstruction, recurrent tonsillitis or chronic tonsillitis reported a high degree (>96%) of symptom relief. Of the patients who underwent tonsillectomy with adenoidectomy, 97.5% were symptom-free compared to 96% of patients who had tonsillectomy alone and 96.1% who underwent tonsillotomy (p < 0.0001). In all, 13.9% of patients required an unplanned visit to the clinic postoperatively. Only 148 of 54,696 patients reported worsening of symptoms after surgery.
    Full-text · Article · Jan 2012 · Acta oto-laryngologica
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    • "The authors state the need for high quality evidence from randomised controlled trials to establish its effectiveness and that these should assess the effectiveness of the procedure in patients with throat infections of differing severity and frequency. A recent Dutch randomised controlled trial of adenotonsillectomy versus watchful waiting reported no differences between treatment arms for children with mild symptoms and only a small difference of less than one episode of fever a year between treatment arms for children with moderate symptoms[27]. "
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    ABSTRACT: Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4-15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001-July 2008). As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives.
    Full-text · Article · Feb 2006 · BMC Ear Nose and Throat Disorders
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