Condition category
Ear, Nose and Throat
Date applied
30/07/2014
Date assigned
04/08/2014
Last edited
15/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
NATTINA is a clinical trial for adults with recurrent acute tonsillitis (inflammation of the tonsils) and is looking to establish the clinical and cost effectiveness of tonsillectomy (surgery to remove the tonsils) compared with conservative management (delayed surgery), which, through observation and statistical modelling of outcomes, will evaluate the impact of alternative sore throat patient pathways and develop future research. The study is split into 3 phases: feasibility, internal pilot and main trial. The feasibility study will explore patient, clinician and GP decision making of acute recurrent tonsillitis and will assess the practicality of the proposed NATTINA trial.

Who can participate?
Patients aged 16 years and over who have been referred to secondary care with recurrent acute tonsillitis.

What does the study involve?
The feasibility study involves in-depth interviews with tonsillitis patients, ENT staff and GPs which will explore patients’ willingness to be randomised, as well as clinician/GP willingness to randomly allocate or refer patients. Interviews will also investigate acceptability of the conservative management treatment group and collate the views and experiences of sore throat and its treatment. The NATTINA internal pilot and main trial involves the randomisation of participants to either tonsillectomy or conservative management. Participants will be followed up for 24 months, during which the patient submits weekly sore throat information, completes 6 monthly questionnaires and attends 2 clinic visits.

What are the possible benefits and risks of participating?
There may be no direct benefit for the patient but the information revealed from this study will help improve the treatment of people with recurrent acute tonsillitis. There are no risks associated with this study.

Where is the study run from?
Newcastle University (UK)

When is the study starting and how long is it expected to run for?
The feasibility study will start in July 2014, the internal pilot in December 2014 and the main trial commencing in June 2015. The study is expected to last 5 years in total, until March 2019.

Who is funding the study?
NIHR Health Technology Assessment (HTA) Programme (UK)

Who is the main contact?
1. Rebecca Harrison (Rebecca.harrison@ncl.ac.uk)
2. Dr Alexander von Wilamowitz-Moellendorff (alexander.von-wilamowitz-moellendorff@newcastle.ac.uk)

Trial website

http://research.ncl.ac.uk/nattina/

Contact information

Type

Scientific

Primary contact

Ms Rebecca Harrison

ORCID ID

Contact details

Newcastle Clinical Trials Unit
1–4 Claremont Terrace
Newcastle University
Newcastle Upon Tyne
NE2 4AE
United Kingdom
-
Rebecca.harrison@ncl.ac.uk

Type

Scientific

Additional contact

Dr Alexander von Wilamowitz-Moellendorff

ORCID ID

Contact details

Newcastle Clinical Trials Unit
1–4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
-
alexander.von-wilamowitz-moellendorff@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16972, HTA 12/146/06

Study information

Scientific title

The NAtional Trial of Tonsillectomy IN Adults: a clinical and cost effectiveness study

Acronym

NATTINA

Study hypothesis

The NATTINA feasibility study will use qualitative and cognitive interviews to assess the practicality of the planned NATTINA internal pilot and full scale randomised controlled trial and will address any key issues raised, as well as evaluate the recruitment process, design and delivery of usual care, the experiences and acceptability of the treatments, acceptibility of the questionnaire design and the outcome measures.

The NATTINA pilot and main trial will estimate treatment effectiveness based on number of sore throat episodes, sore throat severity, quality of life and number of primary/secondary healthcare interactions at baseline and throughout the patient’s 24 month follow-up, which will help to model future patient sore throat pathways and provide more accurate guidelines for tonsillectomy referral. The study will also consider socio-economic aspects and estimate the efficiency to the NHS and patients.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16972 and http://www.nets.nihr.ac.uk/projects/hta/1214606

Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/123354/PRO-12-146-06.pdf

Ethics approval

Feasibility: 15/LO/1115; First MREC approval date 18/06/2014
NATTINA: 14/NE/1144; First MREC approval date 10/11/2014

Study design

Randomised controlled surgical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Available on the NATTINA website or upon request (contact details below)

Condition

Topic: Ear, nose and throat; Subtopic: Ear (all Subtopics); Disease: Ear, nose & throat

Intervention

Feasibility study:
Qualitative Interviews - participants will have an in-depth interview with a researcher
Follow Up Length: 5 month(s)

Main trial:
1. Conservative Management - usual care as normally treated by the patients themselves or the referring GP, comprising self-administered analgesia, +/- ad hoc primary care prescription of antibiotics. Patients are asked to defer surgery for up to 24 months, and reviewed at 12 months to assess their willingness to remain in conservative management arm
2. Immediate Tonsillectomy - immediate Tonsillectomy within 6-8 weeks of randomisation; Study Entry : Registration and One or More Randomisations

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

The number of sore throat days collected through weekly ‘returns’ from the participants over a period of 24 months will be the primary outcome measure. The data will allow comparison of tonsillectomy versus conservative management to determine the effectiveness in recurrent adult tonsillitis.

Secondary outcome measures

1. Responses on the Tonsil Outcome Inventory 14 and STAR data to measure frequency, severity, health and economic impact of any sore throat episodes experienced.
2. Quality-of-life as recorded by SF-12 at the end of study follow up
3. Quality of life using SF-6D scores derived from the SF-12 responses measured at baseline, throughout the study and during episodes of sore throat experienced
4. The number of adverse events, visits to the GP/walk-in clinic/A&E, prescriptions issued and additional interventions required as collected from GP records and other primary care linkage data.
5. Incremental cost per sore throat day avoided from the perspective of the NHS and patients over 24 months to measure the cost effectiveness
6. The views and experiences of patients and clinicians regarding tonsillectomy and conservative management and how patient experience may shape any future research required

Overall trial start date

08/07/2014

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 16 years and over
2. Recurrent sore throats which fulfil current SIGN guidance for elective tonsillectomy.
3. Subject has provided written informed consent for participation in the study prior to any study specific procedures

ENT staff for the feasibility study interviews must be ENT staff members at a participating site and likely to be involved in the proposed NATTINA trial.

There are no exclusion criteria for GPs for the feasibility study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

There will be 45 participants in the feasibility study, 72 in the internal pilot (over 6 months) and 528 in the main trial (18 month recruitment).

Participant exclusion criteria

1. Under 16 years of age
2. Previous tonsillectomy
3. Listed directly (i.e. added to waiting list without prior elective ENT outpatient appointment) during emergency admission (e.g. due to peritonsillar abscess/quinsy)
4. Primary sleep breathing disorder
5. Suspected malignancy
6. Tonsilloliths
7. Pregnant or breastfeeding
8. Bleeding diathesis
9. Therapeutic anticoagulation
10. Inability to complete self-reported questionnaires and sore throat returns

There are no exclusion criteria for GPs or ENT staff for the feasibility study.

Recruitment start date

08/07/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle Clinical Trials Unit
Institute of Health and Society Newcastle University 4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/10/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26047934

Publication citations

Additional files

Editorial Notes

26/02/2016: Publication reference added.