Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial
bmj, 2023•bmj.com
Objective To assess the clinical effectiveness of septoplasty. Design Multicentre,
randomised controlled trial. Setting 17 otolaryngology clinics in the UK's National Health
Service. Participants 378 adults (≥ 18 years, 67% men) newly referred with symptoms of
nasal obstruction associated with septal deviation and at least moderate symptoms of nasal
obstruction (score> 30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale).
Interventions Participants were randomised 1: 1 to receive either septoplasty (n= 188) or …
randomised controlled trial. Setting 17 otolaryngology clinics in the UK's National Health
Service. Participants 378 adults (≥ 18 years, 67% men) newly referred with symptoms of
nasal obstruction associated with septal deviation and at least moderate symptoms of nasal
obstruction (score> 30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale).
Interventions Participants were randomised 1: 1 to receive either septoplasty (n= 188) or …
Objective
To assess the clinical effectiveness of septoplasty.
Design
Multicentre, randomised controlled trial.
Setting
17 otolaryngology clinics in the UK’s National Health Service.
Participants
378 adults (≥18 years, 67% men) newly referred with symptoms of nasal obstruction associated with septal deviation and at least moderate symptoms of nasal obstruction (score >30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale).
Interventions
Participants were randomised 1:1 to receive either septoplasty (n=188) or defined medical management (n=190, nasal steroid and saline spray for six months), stratified by baseline symptom severity and sex.
Main outcome measures
The primary outcome measure was patient reported score on the Sino-Nasal Outcome Test-22 (SNOT-22) at six months, with 9 points defined as the minimal clinically important difference. Secondary outcomes included quality of life and objective nasal airflow measures.
Results
Mean SNOT-22 scores at six months were 19.9 (95% confidence interval 17.0 to 22.7) in the septoplasty arm (n=152, intention-to-treat population) and 39.5 (36.1 to 42.9) in the medical management arm (n=155); an estimated 20.0 points lower (better) for participants randomised to receive septoplasty (95% confidence interval 16.4 to 23.6, P<0.001, adjusted for baseline continuous SNOT-22 score and the stratification variables sex and baseline NOSE severity categories). Greater improvement in SNOT-22 scores was predicted by higher baseline symptom severity scores. Quality of life outcomes and nasal airflow measures (including peak nasal inspiratory flow and absolute inhalational nasal partitioning ratio) improved more in participants in the septoplasty group. Readmission to hospital with bleeding after septoplasty occurred in seven participants (4% of 174 who had septoplasty), and a further 20 participants (12%) required antibiotics for infections.
Conclusions
Septoplasty is a more effective intervention than a defined medical management regimen with a nasal steroid and saline spray in adults with nasal obstruction associated with a deviated nasal septum.
Trial registration
ISRCTN Registry ISRCTN16168569.
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