Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial

Heidi M Kaski, Antti Alakärppä, Ulla Lantto, Aleksi Laajala, Paulus Tokola, Tomi Penna, Pasi Ohtonen, Olli-Pekka Alho, Heidi M Kaski, Antti Alakärppä, Ulla Lantto, Aleksi Laajala, Paulus Tokola, Tomi Penna, Pasi Ohtonen, Olli-Pekka Alho

Abstract

Background: Endoscopic sinus surgery (ESS) has been used for decades to treat recurrent acute rhinosinusitis episodes (RARS) in adults. RARS results in infectious symptoms, antibiotic courses, sick leaves, and impaired quality of life. Theoretically, the ESS procedure, through improving the drainage of the paranasal sinuses, decreases the symptoms and enhances the quality of life of the RARS patients. Whether this is true has not been reported in a randomized trial yet.

Methods: We conduct a single-center, non-blinded, randomized, 6-month, parallel group superiority clinical study including 80 adult participants referred to surgical treatment for RARS. The participants will either have ESS or conservative medical treatment (control group). The primary outcome will be the difference between the mean disease-specific Sinonasal Outcome Test 22 (quality of life questionnaire) change scores (from baseline to 6 months) of ESS and control group.

Discussion: This study will add significant new information to the effect and harms of ESS procedure in the treatment of adults with RARS.

Trial registration: ClinicalTrials.gov NCT04241016 . Registered on 17 January 2020.

Keywords: Endoscopic sinus surgery; Quality of life; Randomized controlled trial; Recurrent rhinosinusitis; Rhinosinusitis; Treatment.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

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