Adults with nasal obstruction associated with a deviated nasal septum fare better after septoplasty than with medical management, according to a multicentre study conducted by UK researchers.
When the trial was commissioned by the National Institute for Health and Care Research in 2014, there was no high quality evidence to suggest that septoplasty was preferential to nonsurgical methods for improving symptoms of nasal obstruction due to deviated septum. Neither was there specific guidance on surgical referral or likely outcomes, nor objective nasal airflow measures to aid selection of patients for surgery. "The intervention was practice-based, not evidence-based," the researchers said.
In 2019, a randomised trial in the Netherlands provided some evidence to suggest that septoplasty improved quality of life more than nonsurgical management, but UK guidelines were not updated.
Access to Septoplasty Often Restricted
The current clinical commissioning guidelines often propose a trial of medical treatment before surgical referral. This usually involves intranasal steroid sprays, despite inconsistent recommendations on dose and length of treatment. Some providers only fund septoplasty if nasal obstruction causes documented medical problems, or only after all nonsurgical treatments have been exhausted. Furthermore, some NHS commissioning bodies in England have placed septoplasty on a list of restricted treatments.
For the study, published in The BMJ, researchers designed the nasal airways obstruction study (NAIROS) "to provide definitive evidence and recommendations for the clinical effectiveness of septoplasty," as well as to show which patients might benefit, and to standardise treatment across the UK.
They recruited 378 adults (average age 40; 67% men) newly-referred to 17 NHS otolaryngology clinics with symptoms of nasal obstruction. Symptoms were confirmed by a presenting score of 30 or over (of a potential 100 maximum) on the nasal obstruction and symptom evaluation (NOSE) scale, and associated with septal deviation confirmed by endoscopy. Participants were randomly assigned to receive either septoplasty (188) or medical management in the form of a nasal steroid and saline spray (190).
SNOT-22 Scores Improved More With Septoplasty
For the primary outcome measure, results were evaluated after 6 months by the Sinonasal Outcome Test-22 (SNOT-22), which assesses 22 symptoms each scored from zero to five, giving a maximum 110, with higher scores indicating worse symptoms. A 9 point difference on this scale was defined as the minimal clinically important difference.
After taking into account age, sex, and severity of baseline symptoms, average SNOT-22 scores at 6 months were 19.9 in the septoplasty group versus 39.5 in the medical management group – a 20 point greater improvement in symptoms on average for those who received septoplasty (95% confidence interval 16.4 to 23.6, P<0.001).
The degree of improvement in symptoms as measured by SNOT-22 was closely related to baseline severity stratification as measured by NOSE scores, the authors reported. Moreover the improvement in SNOT-22 scores remained across each of four SNOT-22 subdomains: nose, sleep, ear/facial pain, and psychological. The difference in SNOT-22 scores remained at 12 months, although to a lesser extent, with scores of 21.2 in the septoplasty group compared with 30.4 in the medical management group.
Specific complications related to septoplasty were:
- Readmissions with bleeding (4%).
- Infections requiring antibiotics (12%).
- Altered sense of smell (11%).
- Upper teeth numbness (11%).
- Changed appearance of the nose (10%).
- Clinician-observed adhesions (4%).
- Clinician-observed septal perforations (3%).
No participants required repeat surgery.
Septoplasty the Superior Treatment
Adults affected with at least moderate symptoms of deviated nasal septum "can reliably be offered surgery," and baseline NOSE scores "can estimate the likely improvement in symptoms and guide decision making," the team concluded.
Asked to comment by Medscape News UK, lead author Sean Carrie, who is also an ENT UK trustee, and coauthor James O’Hara, ENT UK research specialty lead, both from Newcastle upon Tyne Hospitals NHS Foundation Trust, said that the trial showed "the superiority of septoplasty in comparison with nasal steroid spray for patients with at least moderate symptoms of nasal obstruction."
"The trial results confirm that improvement is greater in those with more severe symptoms at outset. This is the first trial to compare septoplasty to a standardised medical alternative, and adds to the existing evidence to inform individual doctor-patient discussions," they said. "In addition, the outputs of NAIROS should inform individual discussions with health commissioners to improve the equity of access to septoplasty across the UK."
Study Gives "Strong Evidence Base Supporting Septoplasty"
In a linked editorial, consultant rhinologist Annakan Navaratnam and senior clinical fellow Alfonso Luca Pendolino, both from the Royal National ENT and Eastman Dental Hospitals in London, said the "landmark" new study findings were "compelling," and provided "a strong evidence base supporting septoplasty."
They urged: "It is vital that these findings now translate into guidance to ensure all patients with suitable pathology are offered this effective intervention."