Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Number of sore throat episodes after TE vs. TO.
Study Overview
Brief Summary
Background: recurrent acute tonsillitis (RT) is a frequent condition affecting teenagers and adults. Patients suffer from recurring throat symptoms, fever and impaired quality of life (QOL). Tonsillectomy (TE) is the only well-known treatment, but studies indicate that tonsillotomy (TO) is associated with less morbidity (eg. pain and bleeding) and equal efficiency (e.g. reduced number of sore throat episodes and improved QOL). The investigator aim to clarify whether TO is a non-inferior alternative to TE.
Methods: inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up. Comparisons will be made between groups, and outcome measures includes number of sore throat episodes, QOL and postoperative pain.
Discussion: the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure (TO) associated with less discomfort and risk than the current standard procedure (TE) and a presumably low risk of insufficiency.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (age ≥15 years) with RT, defined as a minimum of five tonsillitis episodes in one year or a minimum of three tonsillitis episodes per year for two years (Danish National Guidelines criteria
- •The ability to understand Danish orally and in writing.
Exclusion Criteria
- •Previous TE or TO.
- •Suspected tonsillar malignancy.
- •History of malignant tumor in the oral cavity, the pharynx or the larynx.
- •Previous radiation therapy on head or neck.
- •Hemorrhagic diathesis or anticoagulant therapy.
Arms & Interventions
Tonsillectomy
The current standard surgical procedure for treating recurrent acute tonsillitis.
Intervention: Tonsillectomy (Procedure)
Tonsillotomy
A potential non-inferior surgical procedure for treating recurrent acute tonsillitis.
Intervention: Tonsillotomy (Procedure)
Outcomes
Primary Outcomes
Number of sore throat episodes after TE vs. TO.
Time Frame: 12 months (and 24, 36 and 60 months)
QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO
Time Frame: 12 months (and 24, 36 and 60 months)
A disease-specific questionnaire for adults with tonsillitis. It is used pre- and postoperatively to detect changes in quality of life. It consists of 14 questions that covers four subscales: throat dis-comfort (question 1-4) general health (question 5-6), resources (question 7-10), and social psychological restrictions (question 11-14). The questionnaire uses a six-point Likert scale with 0 representing "no problem" and 5 representing "couldn't be worse". The points are summed, divided by the number of questions multiplied by 5, and multiplied by 100, giving scores in the range 0-100, where higher scores reflect poorer quality of life
Summarized postoperative pain scores (days 1-10)
Time Frame: Days 1-10
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no pain" and 10 represents "excruciating pain"
Overall postoperative discomfort (day 21)
Time Frame: Day 21
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no discomfort" and 10 represents "excruciating discomfort"
Secondary Outcomes
- Number of sore throat days after TE vs. TO(12 months (and 24, 36 and 60 months))
- Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO(12 months (and 24, 36 and 60 months))
- Overall patient satisfaction after TE vs. TO(12 months (and 24, 36 and 60 months))
- Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO(12 months (and 24, 36 and 60 months))
- Prevalence of reoperation after TE vs. TO(12 months (and 24, 36 and 60 months))
Investigators
Tejs Ehlers Klug
MD, DMSc, Clinical Associate Professor
Aarhus University Hospital