Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial.

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).

Septoplasty versus non-surgical management for nasal obstruction due to a deviated nasal septum in adults: A modelling study of cost-effectiveness.

OBJECTIVE: The objective of this study was to demonstrate how decision-analytic modelling can help to determine circumstances under which surgery may become cost-effective, using septoplasty as an example. DESIGN: We developed a decision-analytic model comparing septoplasty to non-surgical management for nasal obstruction in adults with a deviated septum. Based on the estimated cost difference between both treatments, we calculated the minimal (a) gain in quality-adjusted life-years, or (b) reduction in productivity losses needed for septoplasty to be cost-effective. Input was derived from literature and publicly available data sources. The time horizon of our model was one year, and the willingness-to-pay per quality-adjusted life-year was €20 000, in accordance with current guidelines. RESULTS: The cost difference between septoplasty and non-surgical management for nasal obstruction due to a deviated nasal septum was €2227 per patient from a healthcare perspective (including direct healthcare costs) and €3288 per patient from an extended perspective (additionally including travel expenses and productivity losses due to poor health). In comparison with non-surgical management, septoplasty needed to gain 0.11 to 0.16 QALYs or save 13 sick days for nasal obstruction. The longer septoplasty's effect lasts, the more time it will have to compensate its extra costs. CONCLUSION: This study shows that the known cost difference between treatments can be used as the starting point to determine beneficial effects needed for cost-effectiveness of surgical interventions. The effect required by septoplasty from a healthcare perspective seems potentially achievable, meaning that it would be useful to perform an RCT assessing the actual benefits of septoplasty.