The National Trial of Tonsillectomy in Adults

Not Applicable

Completed

• Conditions: Subtopic: Ear (all Subtopics); Acute tonsillitis; Disease: Ear, nose & throat; Topic: Ear, nose and throat; Ear, Nose and Throat

• Registration Number: ISRCTN55284102
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26047934 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37209706/ (added 22/05/2023) 2023 Results article in https://doi.org/10.3310/ykur3660 (added 11/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-04
• Study Completion: 2020-06-24
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 645

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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. <br>2. Quality-of-life as recorded by SF-12 at the end of study follow up<br>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<br>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. <br>5. Incremental cost per sore throat day avoided from the perspective of the NHS and patients over 24 months to measure the cost effectiveness<br>6. The views and experiences of patients and clinicians regarding tonsillectomy and conservative management and how patient experience may shape any future research required