Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

Tejs Ehlers Klug

Status: Enrolling

Conditions: Tonsillitis Recurrent

Treatments: Procedure: Tonsillectomy; Procedure: Tonsillotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06606262

TETO study protocol

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Tonsillotomy

Experimental group

Description:

A potential non-inferior surgical procedure for treating recurrent acute tonsillitis.

Treatment:

Procedure: Tonsillotomy

Tonsillectomy

Active Comparator group

Description:

The current standard surgical procedure for treating recurrent acute tonsillitis.

Treatment:

Procedure: Tonsillectomy