Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial

Abstract

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.

Fig 1

Flow of participants through study

Fig 2

Forest plot of primary analysis and sensitivity analysis for intention-to-treat population. CI=confidence interval

Fig 3

Box plots showing summary statistics for SNOT-22 scores in intention-to-treat groups. Box represents middle 50% of data (lower quartile to upper quartile), horizontal line in box shows median (50th centile), whiskers show data that fall within 1.5× interquartile range, and points show data that fall outside these limits. SNOT-22=Sino-Nasal Outcome Test-22

Fig 4

Outcome data using subpopulation treatment effect pattern plot to assess individual changes in SNOT-22 scores from baseline to six months. Purple line shows average effect of being randomised to septoplasty for those with specific NOSE scores at baseline and shading represents 95% confidence intervals. Minimal clinically important difference is 9 points on SNOT-22. NOSE=Nasal Obstruction and Symptom Evaluation; SNOT-22=Sino-Nasal Outcome Test-22