The effectiveness of adenotonsillectomy in children
| ISRCTN | ISRCTN04973569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04973569 |
| Secondary identifying numbers | NTR940 |
- Submission date
- 02/05/2007
- Registration date
- 02/05/2007
- Last edited
- 26/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Anne G.M. Schilder
Scientific
Scientific
University Medical Centre Utrecht
Wilhelmina Children's Hospital
Department of Otorhinolaryngology
PO Box 85090
Utrecht
3508 AB
Netherlands
| Phone | +31 (0)30 250 4004 |
|---|---|
| A.Schilder@umcutrecht.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The effectiveness of adenotonsillectomy in children NATAN project: Nederlands AdenoTonsillectomie project, Tonsillectomy & Adenoidectomy in the Netherlands |
| Study acronym | NATAN |
| 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(s) | Approval received from the Medical Ethical Committee on the 10th January 2000 (ref: 99-49). |
| Condition | Throat infections, Adenotonsillectomy, Adenotonsillar hypertrophy |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/03/2000 |
| Overall study end date | 01/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 8 Years |
| Sex | Not Specified |
| Target number of participants | 300 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 01/03/2000 |
| Recruitment end date | 01/02/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Government
The Dutch Health Care Insurance Board (CVZ) (Netherlands) - knowledge development programme (programma Ontwikkelingsgeneekunde)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/09/2004 | Yes | No | |
| Results article | results | 01/11/2007 | Yes | No | |
| Results article | results | 01/10/2009 | Yes | No |
