RecruitingNot ApplicableNCT06606262

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


Sponsor

Tejs Ehlers Klug

Enrollment

250 participants

Start Date

Oct 31, 2024

Study Type

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

Min Age: 15 Years

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURETonsillotomy

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.

PROCEDURETonsillectomy

Bilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection.


Locations(2)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06606262


Related Trials