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Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis : study protocol for a randomized controlled trial |
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| Author: | Kaski, Heidi M.1,2,3; Alakärppä, Antti1,2,3; Lantto, Ulla1,2,3; |
| Organizations: |
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
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| Format: | article |
| Version: | published version |
| Access: | open |
| Online Access: | PDF Full Text (PDF, 0.7 MB) |
| Persistent link: | http://urn.fi/urn:nbn:fi-fe2021111855819 |
| Language: | English |
| Published: |
Springer Nature,
2021
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| Publish Date: | 2021-11-18 |
| Description: |
AbstractBackground: 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. see all
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| Series: |
Trials |
| ISSN: | 1745-6215 |
| ISSN-E: | 1745-6215 |
| ISSN-L: | 1745-6215 |
| Volume: | 22 |
| Issue: | 1 |
| Article number: | 606 |
| DOI: | 10.1186/s13063-021-05576-z |
| OADOI: | https://oadoi.org/10.1186/s13063-021-05576-z |
| Type of Publication: |
A1 Journal article – refereed |
| Field of Science: |
3126 Surgery, anesthesiology, intensive care, radiology |
| Subjects: | |
| Funding: |
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. |
| Copyright information: |
© The Author(s). 2021. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
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https://creativecommons.org/licenses/by/4.0/ |