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

Sean Carrie (Lead / Corresponding author), James O'Hara, Tony Fouweather, Tara Homer, Nikki Rousseau, Leila Rooshenas, Alison Bray, Deborah D. Stocken, Laura Ternent, Katherine Rennie, Emma Clark, Nichola Waugh, Alison J. Steel, Jemima Dooley, Michael Drinnan, David Hamilton, Kelly Lloyd, Yemi Oluboyede, Caroline Wilson, Quentin GardinerNaveed Kara, Sadie Khwaja, Samuel C. Leong, Sangeeta Maini, Jillian Morrison, Paul Nix, Janet A. Wilson, M. Dawn Teare

    Research output: Contribution to journalArticlepeer-review

    1 Citation (Scopus)
    27 Downloads (Pure)

    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.

    Original languageEnglish
    Article numbere075445
    Number of pages10
    JournalBMJ (Clinical research ed.)
    Volume383
    DOIs
    Publication statusPublished - 18 Oct 2023

    Keywords

    • Adult
    • Male
    • Humans
    • Female
    • Nasal Obstruction/etiology
    • Quality of Life
    • State Medicine
    • Nasal Septum/surgery
    • Treatment Outcome
    • Steroids

    ASJC Scopus subject areas

    • General Medicine

    Fingerprint

    Dive into the research topics of 'Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial'. Together they form a unique fingerprint.

    Cite this