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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
Trials ( IF 2.5 ) Pub Date : 2021-09-08 , DOI: 10.1186/s13063-021-05576-z
Heidi M Kaski 1, 2, 3 , Antti Alakärppä 1, 2, 3 , Ulla Lantto 1, 2, 3 , Aleksi Laajala 1, 2, 3 , Paulus Tokola 1, 2, 3 , Tomi Penna 1, 2, 3 , Pasi Ohtonen 4 , Olli-Pekka Alho 1, 2, 3
Affiliation  

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. 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. This study will add significant new information to the effect and harms of ESS procedure in the treatment of adults with RARS. ClinicalTrials.gov NCT04241016 . Registered on 17 January 2020

中文翻译:

内窥镜鼻窦手术 (ESS) 改变成人复发性鼻鼻窦炎的生活质量:随机对照试验的研究方案

内窥镜鼻窦手术 (ESS) 几十年来一直用于治疗成人复发性急性鼻窦炎发作 (RARS)。RARS 会导致感染症状、抗生素疗程、病假和生活质量下降。理论上,ESS 手术通过改善鼻旁窦的引流,减轻了 RARS 患者的症状并提高了生活质量。这是否属实尚未在随机试验中报告。我们进行了一项单中心、非盲法、随机、6 个月、平行组优效性临床研究,其中包括 80 名接受 RARS 手术治疗的成年参与者。参与者将接受 ESS 或保守治疗(对照组)。主要结果将是 ESS 和对照组的平均疾病特异性鼻腔结果测试 22(生活质量问卷)变化评分(从基线到 6 个月)之间的差异。这项研究将为 ESS 手术治疗成人 RARS 的效果和危害增加重要的新信息。ClinicalTrials.gov NCT04241016。2020 年 1 月 17 日注册
更新日期:2021-09-08
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