The effectiveness of adenotonsillectomy in children.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR940
• Date of registration: 26/03/2007
• Primary sponsor: University Medical Center Utrecht (UMCU)
• 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. - NATAN
• Date of first enrolment: 1/3/2000
• Target sample size: 300
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=940
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Anne G.M. Schilder

• Name: Anne G.M. Schilder

Key inclusion & exclusion criteria

Inclusion criteria: Children aged 2 to 8 years indicated for adenotonsillectomy according to current medical practice. These included children with recurrent throat infections (3 or more episodes per year) or other indications such as obstructive complaints or recurrent upper respiratory infections.
Exclusion criteria: Children with:

1. A history of 7 or more throat infections in the preceding year, or 5 or more in each of the two preceding years, or 3 or more in each of the 3 preceding years (Paradise criteria);

2. High suspicion of obstructive sleep apnoea, i.e. Brouillette¡¦s OSA-score of more than 3.5;

3. Down¡¦s syndrome;

4. Craniofacial malformation, such as cleft palate;

5. Documented immunodeficiency, other than IgA or IgG2 deficiencies.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Throat infections , Adenotonsillar hypertrophy , Adenotonsillectomy

Intervention(s)

Adenotonsillectomy within 6 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, rhinorrhea, earache and otorrhea. 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 (TAPQoL, TACQoL, and CHQpf50) 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 1 year follow-up to evaluate changes in serum immunoglobulin levels in relation to surgery and occurrence of 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

Primary Outcome(s)

Incidence of fever episodes defined as a body-temperature of 38.0 C or higher for at least one day.

Secondary Outcome(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 ID(s)

ISRCTN04973569

Source(s) of Monetary Support

CVZ - programma Ontwikkelingsgeneekunde