Contact information
Type
Scientific
Primary contact
Prof John Bond
ORCID ID
Contact details
Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
+44 (0)191 222 6777
john.bond@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 99/20/03
Study information
Scientific title
Acronym
NESTAC
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
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
The number of reported episodes of sore throat in the two years following date of randomisation.
Secondary outcome measures
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
Overall trial start date
01/09/2001
Overall trial end date
31/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Children <16 years with recurrent sore throat
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
406
Participant 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
Recruitment start date
01/09/2001
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
+44 (0)191 233 6161
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16899123
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20302811
Publication citations
-
Protocol
Bond J, Wilson J, Eccles M, Vanoli A, Steen N, Clarke R, Zarod A, Lock C, Brittain K, Speed C, Rousseau N, Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats., BMC Ear Nose Throat Disord, 2006, 6, 13, doi: 10.1186/1472-6815-6-13.
-
Results
Lock C, Wilson J, Steen N, Eccles M, Mason H, Carrie S, Clarke R, Kubba H, Raine C, Zarod A, Brittain K, Vanoli A, Bond J, North of England and Scotland Study of Tonsillectomy and Adeno-tonsillectomy in Children(NESSTAC): a pragmatic randomised controlled trial with a parallel non-randomised preference study., Health Technol Assess, 2010, 14, 13, 1-164, iii-iv, doi: 10.3310/hta14130.