NESTAC: North of England Study of Tonsillectomy and Adeno-tonsillectomy in Children

ISRCTN ISRCTN47891548
DOI https://doi.org/10.1186/ISRCTN47891548
Secondary identifying numbers HTA 99/20/03
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

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
Email john.bond@newcastle.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymNESTAC
Study objectives1. 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) studiedEar, nose and throat diseases
InterventionPlease 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 typeOther
Primary outcome measureThe number of reported episodes of sore throat in the two years following date of randomisation.
Secondary outcome measures1. 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
Overall study start date01/09/2001
Completion date31/08/2008

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit16 Years
SexBoth
Target number of participants406
Key inclusion criteriaChildren <16 years with recurrent sore throat
Key exclusion criteriaAdded 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 enrolment01/09/2001
Date of final enrolment31/08/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom

Phone +44 (0)191 233 6161
Website http://www.newcastle-hospitals.org.uk/index.aspx
ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 09/08/2006 Yes No
Results article results 01/03/2010 Yes No