Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
ConditionTonsillitis Recurrent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorTejs Ehlers Klug
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tonsillotomy
Procedure/SurgeryBilateral 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
Procedure/SurgeryBilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: TonsillotomyExperimental treatment 1 intervention
Group B: TonsillectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of sore throat episodes after TE vs. TO.
Time frame
12 months (and 24, 36 and 60 months)2
QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO
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
Time frame
12 months (and 24, 36 and 60 months)3
Summarized postoperative pain scores (days 1-10)
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no pain" and 10 represents "excruciating pain"
Time frame
Days 1-104
Overall postoperative discomfort (day 21)
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no discomfort" and 10 represents "excruciating discomfort"
Time frame
Day 21Secondary outcomes
1
Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO
Time frame
12 months (and 24, 36 and 60 months)2
Overall patient satisfaction after TE vs. TO
Patients will be asked the following question: "Keeping in mind your full experience and the effects of surgery so far, are you satisfied with having undergone surgery?. Possible answers are 1) "yes", 2) "no" and 3) "I don't know"
Time frame
12 months (and 24, 36 and 60 months)3
Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO
A generic questionnaire for otorhinolaryngological interventions. It is used post-intervention to detect changes in quality of life. It consists of 18 questions that covers three subscales: a general health sub-scale (question 1-6, 9-10, 14, 16-18), a social support subscale (question 7, 11 and 15) and a physical health subscale (question 8, 12-13). The questionnaire uses a five-point Likert scale with 1 representing "worst change of health status" and 5 representing "best change of health status". The points are summed and divided by the number of questions (resulting in average scores), and by subtracting 3 and multiplying by 50, the final scores range from -100 to +100. 0 indicates no change, higher scores reflect better quality of life
Time frame
12 months (and 24, 36 and 60 months)4
Number of sore throat days after TE vs. TO
Time frame
12 months (and 24, 36 and 60 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tejs Ehlers Klug
Lead sponsor
Aarhus University Hospital
Sponsor institution
University of Aarhus
Collaborator
Source ClinicalTrials.gov