Abstract
BackgroundEndoscopic 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.MethodsWe 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.DiscussionThis study will add significant new information to the effect and harms of ESS procedure in the treatment of adults with RARS.Trial registrationClinicalTrials.govNCT04241016. Registered on 17 January 2020
Highlights
Background and rationale {6a} Endoscopic sinus surgery (ESS) is among the most common surgical procedures in the field of ear, nose, and throat diseases
In our population-based cohort study, where we examined the quality of life (QoL) benefits of primary sinonasal surgery, some 40% of the patients suffered from recurrent acute rhinosinusitis episodes (RARS) [2]
3) Difference in the numbers of rhinosinusitis episodes, medical visits, antimicrobial treatments, and days lost from work or studies between the ESS and control groups during the follow-up
Summary
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
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