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04 February 2012
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| [ Print-friendly version ] |
| NESTAC: North of England Study of Tonsillectomy and Adeno-tonsillectomy in Children |
| ISRCTN | ISRCTN47891548 |
| ClinicalTrials.gov identifier | |
| Public title | NESTAC: North of England Study of Tonsillectomy and Adeno-tonsillectomy in Children |
| Scientific title | |
| Acronym | NESTAC |
| Serial number at source | HTA 99/20/03 |
| Study hypothesis |
1. To investigate the clinical effectiveness of surgical intervention compared with non-surgical intervention in children under 16 with recurrent sore throat.
2. To investigate the relative costs and benefits of surgical and non-surgical interventions to the NHS and families. 3. To identify important outcomes for children and parents and to evaluate the impact on children's quality of life. 4. To investigate older children's and parents' preference for different treatment options. Protocol can be found at http://www.hta.ac.uk/protocols/199900200003.pdf More details can be found at http://www.hta.ac.uk/1212 |
| Lay summary | |
| Ethics approval | Not provided at time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Ear, nose and throat diseases |
| Participants - inclusion criteria | Children <16 years with recurrent sore throat |
| Participants - exclusion criteria |
Added 21/06/10:
1. Hospitalisation due to peritonsillar abscess (quinsy) 2. Obstructive symptoms suggestive of clinicially significant sleep apnoea syndrome 3. Rare medical conditions such as glomerulonephritis or Henoch Schonlein purpura 4. Previous tonsillectomy 5. Suspected velopharyngeal insufficiency 6. Co-morbidity that means patient is unable to undergo surgery within the next six months 7. Bleeding disorders 8. Congenital/valvular heart disease |
| Anticipated start date | 01/09/2001 |
| Anticipated end date | 31/08/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 406 |
| Interventions |
Please note that, as of 15 January 2008, the anticipated end date of this trial has been updated from 30 September 2006 to 31 August 2008.
Interventions: Surgical intervention vs non-surgical intervention |
| Primary outcome measure(s) | The number of reported episodes of sore throat in the two years following date of randomisation. |
| Secondary outcome measure(s) |
1. The number of recorded episodes of sore throat from primary care practice records
2. Surgical and anaesthetic morbidity 3. Time off school 4. Parental time off work 5. Consumption of antibiotics and analgesics 6. Health-related quality of life 7. Child and parental satisfaction |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications |
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16899123
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20302811 |
| Contact name | Prof John Bond |
| Address |
Centre for Health Services Research
University of Newcastle upon Tyne 21 Claremont Place |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE2 4AA |
| Country | United Kingdom |
| Tel | +44 (0)191 222 6777 |
| Fax | +44 (0)191 222 6043 |
| john.bond@newcastle.ac.uk | |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Address |
Freeman Hospital
Freeman Road High Heaton |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE7 7DN |
| Country | United Kingdom |
| Tel | +44 (0)191 233 6161 |
| Sponsor website: | http://www.newcastle-hospitals.org.uk/index.aspx |
| Date applied | 25/04/2003 |
| Last edited | 21/06/2010 |
| Date ISRCTN assigned | 25/04/2003 |
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