Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial
Tejs Ehlers Klug
250 participants
Oct 31, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria5
- 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.
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Interventions
Bilateral partial removal of the palatine tonsils to a level between the pharyngeal pillars and the tonsillar capsule. Surgery will be performed under general anesthesia using monopolar electrocautery.
Bilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06606262