Kaski, H.M., Alakärppä, A., Lantto, U. et al. Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial. Trials 22, 606 (2021). https://doi.org/10.1186/s13063-021-05576-z
Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis : study protocol for a randomized controlled trial
|Author:||Kaski, Heidi M.1,2,3; Alakärppä, Antti1,2,3; Lantto, Ulla1,2,3;|
1Department of Otorhinolaryngology and Head and Neck Surgery, Oulu University Hospital, P.O. Box 5000, FIN-90014, Oulu, Finland
2PEDEGO Research Unit, University of Oulu, Oulu, Finland
3Division of Operative Care, Oulu University Hospital, Oulu, Finland
4Medical Research Center Oulu, Oulu, Finland
|Online Access:||PDF Full Text (PDF, 0.7 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2021111855819
|Publish Date:|| 2021-11-18
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.govNCT04241016. Registered on 17 January 2020.
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3126 Surgery, anesthesiology, intensive care, radiology
This is an investigator initiated study. The participants’ communities finance the clinical visits and treatments with a small deductible paid by the participants. The hospital and university pay the participating physicians’ salaries as usual and they do the research work as part of their daily work. The more extensive scientific work done mainly by the doctoral student (HK) is covered with governmental financing granted for this research project for 2020 and sought for the years 2021–2022. Otherwise, we receive no financial, material, or other support for this work.
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