Condition category
Ear, Nose and Throat
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
21/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.newcastle-hospitals.org.uk/index.aspx

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

  1. 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.

  2. 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.

Additional files

Editorial Notes