Clinical trial NCT06606262: Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Official title: Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tonsillitis Recurrent
Keywords: tonsillectomy
tonsillotomy
quality of life
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2024-09-20
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of sore throat episodes after TE vs. TO.
timeFrame: 12 months (and 24, 36 and 60 months)
measure: QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO
timeFrame: 12 months (and 24, 36 and 60 months)
measure: Summarized postoperative pain scores (days 1-10)
timeFrame: Days 1-10
measure: Overall postoperative discomfort (day 21)
timeFrame: Day 21
Secondary outcomes:
measure: Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO
timeFrame: 12 months (and 24, 36 and 60 months)
measure: Overall patient satisfaction after TE vs. TO
timeFrame: 12 months (and 24, 36 and 60 months)
measure: Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO
timeFrame: 12 months (and 24, 36 and 60 months)
measure: Number of sore throat days after TE vs. TO
timeFrame: 12 months (and 24, 36 and 60 months)
measure: Prevalence of reoperation after TE vs. TO
timeFrame: 12 months (and 24, 36 and 60 months)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: