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Recruiting NCT06606262

Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

No phase Interventional Tonsillitis Recurrent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tonsillotomy, Tonsillectomy.
Who it may be relevant to
Registry conditions: Tonsillitis Recurrent. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial

Overview

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.

Interventions

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

Primary outcome measures

  • Number of sore throat episodes after TE vs. TO. [Time frame: 12 months (and 24, 36 and 60 months)]
  • QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO [Time frame: 12 months (and 24, 36 and 60 months)]
  • Summarized postoperative pain scores (days 1-10) [Time frame: Days 1-10]
  • Overall postoperative discomfort (day 21) [Time frame: Day 21]
Secondary outcome measures (5)
  • Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO [Time frame: 12 months (and 24, 36 and 60 months)]
  • Overall patient satisfaction after TE vs. TO [Time frame: 12 months (and 24, 36 and 60 months)]
  • Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO [Time frame: 12 months (and 24, 36 and 60 months)]
  • Number of sore throat days after TE vs. TO [Time frame: 12 months (and 24, 36 and 60 months)]
  • Prevalence of reoperation after TE vs. TO [Time frame: 12 months (and 24, 36 and 60 months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 2 centers
  • Aalborg University Hospital — Aalborg
  • Aarhus University Hospital — Aarhus

Identifiers

NCT: NCT06606262 · TETO study protocol

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗