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| [ Print-friendly version ] |
| The effectiveness of adenotonsillectomy in children |
| ISRCTN | ISRCTN04973569 |
| ClinicalTrials.gov identifier | |
| Public title | The effectiveness of adenotonsillectomy in children |
| Scientific title | The effectiveness of adenotonsillectomy in children NATAN project: Nederlands AdenoTonsillectomie project, Tonsillectomy & Adenoidectomy in the Netherlands |
| Acronym | NATAN |
| Serial number at source | N/A |
| Study hypothesis | Adenotonsillectomy in children with mild to moderate symptoms of throat infections or adenenotonsillar hypertrophy prevents upper airway infections and fever episodes. |
| Ethics approval | Approval received from the Medical Ethical Committee on the 10th January 2000 (ref: 99-49). |
| Study design | Randomised, active controlled, parallel group, multicentre trial |
| Countries of recruitment | The Netherlands |
| Disease/condition/study domain | Throat infections, Adenotonsillectomy, Adenotonsillar hypertrophy |
| Participants - inclusion criteria | Children aged 2 to 8 years indicated for adenotonsillectomy according to current medical practice. These included children with recurrent throat infections (three or more episodes per year) or other indications such as obstructive complaints or recurrent upper respiratory infections. |
| Participants - exclusion criteria |
Children with:
1. A history of seven or more throat infections in the preceding year, or five or more in each of the two preceding years, or three or more in each of the three preceding years (Paradise criteria) 2. High suspicion of obstructive sleep apnoea, i.e. Brouillette's Obstructive Sleep Apnoea (OSA) score of more than 3.5 3. Down's syndrome 4. Craniofacial malformation, such as cleft palate 5. Documented immunodeficiency, other than Immunoglobulin A (IgA) or Immunoglobulin G subclass two (IgG2) deficiencies |
| Anticipated start date | 01/03/2000 |
| Anticipated end date | 01/02/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 300 |
| Interventions |
Interventions are adenotonsillectomy within six weeks versus watchful waiting.
During the study, the child's temperature was measured daily with a validated infrared tympanic membrane thermometer with an electronic device built in that stored the date and first temperature measurement of each day. Thermometer data were collected by the study physician during scheduled follow-up visits at 3, 6, 12, 18 and 24 months. During the study, parents kept a diary of complaints of upper respiratory infections in their child, i.e., sore throat, pain/difficulty at swallowing, cough, rhinorrhoea, earache and otorrhoea. They also noted absence from day-care or school due to upper respiratory infections, and resource use such as prescription and over the counter medication, out-patient visits, additional surgical interventions and out-of-pocket expenses such as babysitters and travel expenses. Diary data were collected by the study physician during scheduled follow-up visits at 3, 6, 12, 18 and 24 months. On the basis of these data incidences of throat infections, sore throat, upper respiratory infections, absence from day-care or school due to upper respiratory infections and costs were calculated. At inclusion and the scheduled follow-up visits at 3, 6, 12, 18 and 24 months disease-specific and health-related quality of life questionnaires (43-item TNO-AZL Preschool children Quality of Life [TAPQoL], 56-item TNO-AZL Child Quality of Life [TACQoL], and Child Health Questionnaire - Parent Form 50 [CHQ-PF50]) were filled out. An ear, nose and throat examination was performed including tympanometry and length and weight were measured. These data were used to establish the effect of adenotonsillectomy on middle ear status, sleeping and eating pattern, length and weight and health-related quality of life. Serum samples were collected at baseline and at one-year follow-up to evaluate changes in serum immunoglobulin levels in relation to surgery and occurrence of Upper Respiratory Infections (URIs). Oropharyngeal swabs were taken at baseline and at 3 and 12 months follow-up to study the effect of adenotonsillectomy on carriage of potential pathogenic bacteria in the oropharynx at 3 and 12 months follow-up and the association between carriage of these potential pathogens and the number of throat infections during the 12 months follow-up. |
| Primary outcome measure(s) | Incidence of fever (a temperature of 38.0°C or higher) for at least one day, measured in number of episodes and days. An episode was considered finished when at least one day was without fever. New episodes were those occurring after a fever-free interval of at least seven days. |
| Secondary outcome measure(s) |
Secondary outcome measures were:
1. Throat infections 2. Sore throat days and episodes 3. Upper respiratory infections 4. Otitis media 5. Sleeping and eating pattern 6. Length and weight 7. Absence from day-care or school due to upper respiratory infections 8. Health-related quality of life 9. Costs 10. Immunological parameters 11. Oropharyngeal microbial flora Secondary outcomes were measured during follow-up visits at 3, 6, 12, 18 and 24 months. |
| Sources of funding | The Dutch Health Care Insurance Board (CVZ) (The Netherlands) - knowledge development programme (programma Ontwikkelingsgeneekunde) |
| Trial website | |
| Publications |
Results on:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15361407 2. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=18025310 |
| Contact name | Dr Anne G.M. Schilder |
| Address |
University Medical Centre Utrecht
Wilhelmina Children's Hospital Department of Otorhinolaryngology PO Box 85090 |
| City/town | Utrecht |
| Zip/Postcode | 3508 AB |
| Country | Netherlands |
| Tel | +31 (0)30 250 4004 |
| Fax | +31 (0)30 250 5348 |
| A.Schilder@umcutrecht.nl | |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Address | P.O. Box 85500 |
| City/town | Utrecht |
| Zip/Postcode | 3508 GA |
| Country | Netherlands |
| Sponsor website: | http://www.umcutrecht.nl/zorg/ |
| Date applied | 02/05/2007 |
| Last edited | 07/12/2007 |
| Date ISRCTN assigned | 02/05/2007 |
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