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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
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.
Bilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection.
Aalborg University Hospital
Aalborg, Denmark
RECRUITINGAarhus University Hospital
Aarhus, Denmark
RECRUITINGNumber 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
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)
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 1-10
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 21
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
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)
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)
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)
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