Abstract
BackgroundSeptoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited.AimsTo establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum.Methods/designA multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation.DiscussionThe NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit.Trial registrationEudraCT: 2017–000893-12, ISRCTN: 16168569. Registered on 24 March 2017.
Highlights
Septoplasty is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the United Kingdom (UK)
The study objectives are split into three different aspects: clinical effectiveness, economic evaluations and mixedmethod process evaluation
Intervention – septoplasty Participants allocated to the septoplasty group will undergo surgical correction of the nasal septal deviation ± unilateral reduction of the inferior turbinate on the concave side
Summary
Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Septoplasty is a commonly conducted operation worldwide, with approximately 250,000 operations performed annually in the US and approximately 22,000 in the United Kingdom (UK) [1, 2]. Most of these are carried out for nasal blockage and associated symptoms such as a snoring and sleep disturbance. Septal deviation or lesions in the nasal passages, such as nasal polyps or enlarged adenoids or turbinates, may cause a ‘fixed’ sensation of blockage. The impact of the ‘nasal cycle’ can be mitigated by measuring nasal airflow following therapeutic nasal decongestion [3]
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