The National Trial of Tonsillectomy in Adults
| ISRCTN | ISRCTN55284102 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55284102 |
| Secondary identifying numbers | 16972, HTA 12/146/06 |
- Submission date
- 30/07/2014
- Registration date
- 04/08/2014
- Last edited
- 11/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
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 until June 2020.
Who is funding the study?
NIHR Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
Rebecca Wilson
Rebecca.wilson2@ncl.ac.uk
Contact information
Scientific
Newcastle Clinical Trials Unit
1–4 Claremont Terrace
Newcastle University
Newcastle Upon Tyne
NE2 4AE
United Kingdom
| Phone | +44 (0) 191 208 6592 |
|---|---|
| Rebecca.wilson2@ncl.ac.uk |
Study information
| Study design | Randomised controlled surgical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Available on the NATTINA website or upon request (contact details below) |
| Scientific title | The NAtional Trial of Tonsillectomy IN Adults: a clinical and cost effectiveness study |
| Study acronym | NATTINA |
| Study objectives | 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(s) | Feasibility: 15/LO/1115; First MREC approval date 18/06/2014 NATTINA: 14/NE/1144; First MREC approval date 10/11/2014 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 08/07/2014 |
| Completion date | 24/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | 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). |
| Key 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. |
| Key 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. |
| Date of first enrolment | 08/07/2014 |
| Date of final enrolment | 30/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Newcastle University
4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Hospital/treatment centre
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | It is planned to publish this study in peer review articles and to present data at national and international meetings. Results of the study will also be reported to the Sponsor and Funder, and will be available on their website. A lay summary of the study results will be made available to the participants on the NATTINA website at the end of the study. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/06/2015 | Yes | No | |
| Results article | 17/05/2023 | 22/05/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Plain English results | version 1 | 13/07/2023 | 13/07/2023 | No | Yes |
| Results article | 01/12/2023 | 11/01/2024 | Yes | No |
Additional files
Editorial Notes
11/01/2024: Publication reference added.
13/07/2023: The plain English results were uploaded as an additional file.
22/05/2023: Publication reference added.
23/07/2020: The overall trial end date was changed from 12/06/2020 to 24/06/2020.
25/06/2020: The overall trial end date was changed from 30/04/2020 to 12/06/2020.
25/07/2019: Internal review.
10/07/2019: Study contact updated.
23/07/2018: The intention to publish date was changed from 01/10/2019 to 30/04/2021.
07/02/2018: Publication & dissemination plan and participant level data were added.
29/01/2018: The following changes were made:
1. Recruitment end date was changed from 31/12/2016 to 30/04/2018.
2. Overall trial end date was changed from 31/03/2019 to 30/04/2020.
3. Nicola Goudie replaced Rebecca Harrison and Alexander von Wilamowitz-Moellendorff as primary contact for the study.
26/02/2016: Publication reference added.
