BACKGROUND Septoplasty (surgical correction of the deviated nasal septum) is the most frequently performed ear, nose, and throat operation in adults, but no randomised controlled trials or non-randomised comparative studies on the effectiveness of septoplasty have been published. Consequently, health-care providers, health insurance companies, and policy makers are concerned about the effectiveness of the procedure. We aimed to assess the effectiveness of septoplasty for nasal obstruction in adults with a deviated septum. METHODS We did this open, multicentre, pragmatic, randomised controlled trial in 16 secondary and two tertiary referral hospitals in the Netherlands. Adults (aged ≥18 years) with nasal obstruction, a deviated septum, and an indication to have septoplasty done were randomly allocated (1:1) to receive either septoplasty with or without concurrent turbinate surgery or non-surgical management. Patients were stratified by sex, age (<35 years or ≥35 years), and deviation severity (mild, moderate, or severe). The primary outcome was health-related quality of life, measured with the validated Glasgow Health Status Inventory at 12 months. Analyses were done on an intention-to-treat basis. The trial is registered with the Netherlands Trial Register, number NTR3868. FINDINGS Between Sept 2, 2013, and Dec 12, 2016, we randomly assigned 203 participants to receive either septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101). 189 participants were analysed at 12 months. At 12 months, mean score on the Glasgow Health Status Inventory of patients assigned to septoplasty was 72·2 (SD 12·2) and for those assigned to non-surgical management was 63·9 (SD 14·5, mean difference 8·3 [95% CI 4·5-12·1], favouring septoplasty). Septal abscess occurred in one surgical patient and septal perforation in two surgical patients. No side-effects of nasal medication were reported. INTERPRETATION Septoplasty is more effective than non-surgical management for nasal obstruction in adults with a deviated septum. This effect was sustained up to 24 months of follow-up. FUNDING The Netherlands Organisation for Health Research and Development (ZonMw).

中文翻译：

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鼻中隔偏斜的成年人鼻阻塞的联合或不联合鼻甲手术或非手术鼻窦成形术：一项实用，随机对照试验。

背景技术隔膜成形术（鼻中隔偏斜的手术矫正）是成人中最常进行的耳，鼻和喉手术，但尚未有关于隔膜成形术有效性的随机对照试验或非随机比较研究发表。因此，医疗保健提供者，健康保险公司和决策者都对该程序的有效性感到担忧。我们旨在评估隔膜成形术对成人鼻中隔偏曲患者鼻腔阻塞的有效性。方法我们在荷兰的16家二级和二级三级转诊医院中进行了这项开放，多中心，实用，随机对照试验。随机分配鼻子阻塞，鼻中隔偏斜和行隔膜成形术的成年人（≥18岁）（1：1）接受鼻中隔成形术，同时进行或不进行鼻甲手术或非手术治疗。按性别，年龄（<35岁或≥35岁）和偏离严重程度（轻度，中度或重度）对患者进行分层。主要结局是与健康相关的生活质量，以经过验证的12个月的格拉斯哥健康状况清单进行衡量。在意向性治疗的基础上进行了分析。该审判已在荷兰审判登记簿中注册，编号为NTR3868。结果在2013年9月2日至2016年12月12日之间，我们随机分配了203名参与者，以接受或不进行鼻甲联合手术（n = 102）或非手术治疗（n = 101）进行隔膜成形术。在12个月时对189名参与者进行了分析。在12个月后，接受隔隔膜成形术的患者在格拉斯哥健康状况清单上的平均得分为72·2（SD 12·2），而接受非手术治疗的患者的平均得分为63·9（SD 14·5，平均差异8·3 [95％ CI 4·5-12·1]，有利于隔膜成形术。一名手术患者发生间隔脓肿，两名手术患者发生间隔穿孔。没有报告鼻用药物的副作用。解释对于成人鼻中隔偏曲而言，鼻成形术比非手术治疗更有效。这种效果持续了长达24个月的随访。资金荷兰卫生研究与发展组织（ZonMw）。一名手术患者发生间隔脓肿，两名手术患者发生间隔穿孔。没有报告鼻用药物的副作用。解释对于成人鼻中隔偏曲而言，鼻成形术比非手术治疗更有效。这种效果持续了长达24个月的随访。资金荷兰卫生研究与发展组织（ZonMw）。一名手术患者发生间隔脓肿，两名手术患者发生间隔穿孔。没有报告鼻用药物的副作用。解释对于成人鼻中隔偏曲而言，鼻成形术比非手术治疗更有效。这种效果持续了长达24个月的随访。资金荷兰卫生研究与发展组织（ZonMw）。