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.
Tonsillectomy: Bilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection.
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
Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of sore throat episodes after TE vs. TO. — 12 months (and 24, 36 and 60 months)
QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO — 12 months (and 24, 36 and 60 months) A disease-specific questionnaire for adults with tonsillitis. It is used pre- and postoperatively to detect changes in quality of life. It consists of 14 questions that covers four subscales: throat dis-comfort (question 1-4) general health (question 5-6), resources (question 7-10), and social psychological restrictions (question 11-14). The questionnaire uses a six-point Likert scale with 0 representing "no problem" and 5 representing "couldn't be worse". The points are summed, divided by the number of questions multiplied by 5, and multiplied by 100, giving scores in the range 0-100, where higher scores reflect poorer quality of life
Summarized postoperative pain scores (days 1-10) — Days 1-10 Measured on a numeric rating scale from 0 til 10 in which 0 represents "no pain" and 10 represents "excruciating pain"
Overall postoperative discomfort (day 21) — Day 21 Measured on a numeric rating scale from 0 til 10 in which 0 represents "no discomfort" and 10 represents "excruciating discomfort"
Trial sites (2)
Facility
City
Region
Status
Aalborg University Hospital
Aalborg
Denmark
Aarhus University Hospital
Aarhus
Denmark
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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