Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

Last updated: December 17, 2024
Sponsor: Tejs Ehlers Klug
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pharyngitis

Throat And Tonsil Infections

Treatment

Tonsillotomy

Tonsillectomy

Clinical Study ID

NCT06606262
TETO study protocol
  • Ages > 15
  • All Genders

Study 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

Inclusion Criteria:

  • Adults (age ≥15 years) with RT, defined as a minimum of five tonsillitis episodes inone year or a minimum of three tonsillitis episodes per year for two years (DanishNational Guidelines criteria

  • The ability to understand Danish orally and in writing.

Exclusion

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.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Tonsillotomy
Phase:
Study Start date:
October 31, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

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