Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial

Aleksi Laajala, Paulus Tokola, Timo J Autio, Timo Koskenkorva, Mikko Tastula, Pasi Ohtonen, Esa Läärä, Olli-Pekka Alho, Aleksi Laajala, Paulus Tokola, Timo J Autio, Timo Koskenkorva, Mikko Tastula, Pasi Ohtonen, Esa Läärä, Olli-Pekka Alho

Abstract

Background: Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired quality of life (QoL). Theoretically, removing all or part of the altered pathological palatal lymphoid tissue alleviates the symptoms and enhances the QoL. Whether this is true with total or partial tonsillar resection (tonsillectomy (TE) and tonsillotomy (TT), respectively) has not been reported in a randomised trial yet.

Methods: We conduct a multicentre, partly blinded, randomised, 6-month, parallel-group clinical study including 285 adult participants referred to surgical treatment for chronic or recurrent tonsillitis. The participants will either have TE, TT or watchful waiting (WW). The primary outcome will be the difference between the mean disease-specific Tonsillectomy Outcome Inventory-14 (QoL questionnaire) scores at 6 months. Comparison is made firstly between the combined TE+TT and WW groups (superiority analysis), and secondly between the TE and TT groups (non-inferiority analysis).

Discussion: This study will add significant new information to the effects and harms of TE and TT procedures in the treatment of adults with chronic or recurrent tonsillitis.

Trial registration: ClinicalTrials.gov: NCT04657549.

Keywords: Chronic tonsillitis; Quality of life; Randomised controlled trial; Recurrent tonsillitis; Tonsillectomy; Tonsillotomy; Treatment.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
The study flowchart
Fig. 2
Fig. 2
The schedule of enrolment, interventions and assessments. T1 = within 2 to 3 weeks of enrolment, T2 = 3 months follow-up, and T3 = 5–6 months. The study logbook is filled continuously in a mobile phone application between surgery and the end of follow-up for surgical groups and between enrolment and the end of follow-up for the control group. TOI-14 = Tonsillectomy Outcome Inventory – 14, RAND-36 = Research and Development 36-item Health Survey.

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