内镜鼻窦手术（ESS）改善复发性鼻窦炎成人生活质量的随机对照试验研究方案。
Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial.
机构信息
Department of Otorhinolaryngology and Head and Neck Surgery, Oulu University Hospital, P.O. Box 5000, FIN-90014, Oulu, Finland.
PEDEGO Research Unit, University of Oulu, Oulu, Finland.
出版信息
Trials. 2021 Sep 8;22(1):606. doi: 10.1186/s13063-021-05576-z.
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.
背景
内镜鼻窦手术（ESS）已被用于治疗成人复发性急性鼻-鼻窦炎（RARS）数十年。RARS 会导致感染症状、抗生素疗程、病假和生活质量受损。理论上，ESS 手术通过改善鼻窦引流，可以减轻 RARS 患者的症状并提高其生活质量。然而，这一理论是否成立尚未在随机试验中得到证实。
方法
我们进行了一项单中心、非盲、随机、6 个月、平行组优效性临床研究，纳入了 80 名因 RARS 而接受手术治疗的成年患者。这些参与者将被分为 ESS 组或保守药物治疗（对照组）。主要结局是 ESS 组和对照组之间的疾病特异性鼻-鼻窦炎结局测试 22（生活质量问卷）评分变化平均值（从基线到 6 个月）的差异。
讨论
这项研究将为 ESS 手术治疗成人 RARS 的疗效和危害提供重要的新信息。
试验注册
ClinicalTrials.gov NCT04241016。注册于 2020 年 1 月 17 日。
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