Tonsillitis Recurrent
Conditions
Keywords
tonsillectomy, tonsillotomy, quality of life
Brief 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.
Interventions
PROCEDURETonsillotomy
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.
PROCEDURETonsillectomy
Bilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using cold knife dissection.
Sponsors
University of Aarhus
Tejs Ehlers Klug
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO | 12 months (and 24, 36 and 60 months) | — |
| Prevalence of reoperation after TE vs. TO | 12 months (and 24, 36 and 60 months) | — |
| Overall patient satisfaction after TE vs. TO | 12 months (and 24, 36 and 60 months) | 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 |
| Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO | 12 months (and 24, 36 and 60 months) | 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 |
| Number of sore throat days after TE vs. TO | 12 months (and 24, 36 and 60 months) | — |
Countries
Denmark
Contacts
Primary ContactHannah Inez Houborg, MD
Backup ContactTejs Ehlers Klug, MD, DMSc
Outcome results
None listed