Surgery was more effective than medical management for patients with nasal obstruction associated with septal deviation, the multicenter NAIROS trial found.
Patient-reported Sino-Nasal Outcome Test-22 (SNOT-22) scores at 6 months were better in patients who had undergone septoplasty versus those treated with a nasal steroid and saline spray (19.9 vs 39.5, P<0.001), reported researchers led by Sean Carrie, MBChB, of Newcastle Upon Tyne Hospitals NHS Foundation Trust in England.
The difference persisted after adjusting for baseline continuous SNOT-22 score, sex, and baseline Nasal Obstruction and Symptom Evaluation (NOSE) severity, according to the randomized controlled trial published in The BMJ.
“We therefore recommend that adults presenting with nasal obstruction associated with a deviated nasal septum, in the absence of coexistent nasal or sinus disease and with a baseline NOSE score >30, can reliably be offered surgery,” the NAIROS group wrote.
A crooked, or deviated, septum is very common, with up to 80% of the population currently experiencing the condition to varying degrees and symptoms. Approximately 250,000 septoplasties are performed in the U.S. each year.
Septoplasty may also be accompanied by an inferior turbinate reduction, which can increase the airflow throughout the nasal cavities.
Annakan Navaratnam, MBBS, and Alfonso Luca Pendolino, MD, both of the Royal National ENT and Eastman Dental Hospitals in London, expressed caution with recommending septoplasty in an accompanying editorial, noting that the results of the present study do not mean “that all patients with nasal blockage and septal deviation should be offered septoplasty over medical management.”
“A major difficulty in evaluation of septoplasty outcomes is a lack of consensus on the classification of septal deformities. The extent and location of nasal septal deviation was not documented in NAIROS,” they continued. “The type of septal deviation present would potentially indicate which patients may benefit most from septoplasty and which surgical approach should be adopted. Advanced surgery in the form of a functional septorhinoplasty may be warranted in some patients with more complex conditions.”
Carrie and colleagues reported there was no difference in SNOT-22 scores between those getting inferior turbinate reduction versus peers who went without it, a decision that had been left to the discretion of the operating surgeon. They suggested that “further multicenter clinical trials should be considered to define the impact of inferior turbinate reduction in combination with septoplasty.”
Overall in NAIROS, patients in the septoplasty group reported 14 serious adverse events compared to the nasal spray group’s nine events. Common serious adverse events included postoperative bleeding, anaesthetic complications, infection, multi-pill overdose, vasovagal episode, overnight hospital admission after surgery, and unrelated trauma.
A total of 378 patients were included in the trial, with 188 randomized to receive septoplasty and 190 a nasal steroid and saline spray. In order to be eligible for the trial, patients needed to exhibit at least moderate symptoms of nasal obstruction, indicated by a NOSE score of 30 or higher out of 100.
The patient population was 67% men, and the average patient age was 39.8 years. The vast majority of patients were white at 88%, followed by Asian patients at 7%.
Treatment was provided by 17 clinics within the U.K.’s National Health Service. For the patients randomized to receive septoplasty, 77% of procedures were performed by consultant surgeons, while 10% were performed by associate specialists, 10% by another grade of surgeon, and 3% did not have the surgical provider’s grade recorded.
For primary outcome assessment, SNOT-22 is validated to assess symptoms related to chronic rhinosinusitis but has been used to assess outcomes after septal surgery, according to Carrie’s group.
The authors reported that septoplasty’s advantage in SNOT-22 scores shrank somewhat but remained significant at 12 months (21.2 vs 30.4, P<0.001).
Researchers did caution that at baseline, 80% of the patients included in the study were categorized as having severe NOSE scores (55-75) or extreme NOSE scores (80-100), making this more likely a population seeking secondary care for nasal obstruction.
Other limitations of NAIROS include disruptions from COVID-19, which forced the suspension of airway clinical assessment and objective measurements of nasal patency from March 2020 onwards. It is also unknown what can be considered a good course of medical management before one resorts to surgery, though consensus opinion from the U.S. recommends conservative therapy for 4 weeks before septoplasty is considered.
The study was supported by funding from the U.K. National Institute for Health and Care Research.
No disclosures were reported by study authors and editorialists.
Source Reference: Carrie S, et al “Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial” BMJ 2023; DOI: 10.1136/bmj-2023-075445.
Source Reference: Navaratnam AV, Pendolino AL “Septoplasty for nasal obstruction” BMJ 2023; DOI: 10.1136/bmj.p2341.