NESTAC: North of England Study of Tonsillectomy and Adeno-tonsillectomy in Children
| ISRCTN | ISRCTN47891548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47891548 |
| Protocol serial number | HTA 99/20/03 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 21/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof John Bond
Scientific
Scientific
Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
| Phone | +44 (0)191 222 6777 |
|---|---|
| john.bond@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | NESTAC |
| Study objectives | 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 |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Ear, nose and throat diseases |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure(s) |
The number of reported episodes of sore throat in the two years following date of randomisation. |
| Key secondary outcome measure(s) |
1. The number of recorded episodes of sore throat from primary care practice records |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 406 |
| Key inclusion criteria | Children <16 years with recurrent sore throat |
| Key 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 |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom
NE2 4AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/03/2010 | Yes | No | |
| Protocol article | protocol | 09/08/2006 | Yes | No |
