Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

Recruiting now · Not applicable

Conditions studied: Tonsillitis Recurrent

In brief

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.

Key facts

Study ID

NCT06606262

Run by

Tejs Ehlers Klug

People needed

250

Starts

2024-10-31

Expected to finish

2029-12-31

Last updated by the study team

2024-12-19

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aalborg University Hospital — Aalborg, Denmark (enrolling)
• Aarhus University Hospital — Aarhus, Denmark (enrolling)

Full record on ClinicalTrials.gov

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