Full and limited functional endoscopic sinus surgery were associated with clinically meaningful improvements in disease-specific health-related quality of life over 24 months among patients with uncontrolled chronic rhinosinusitis with nasal polyps requiring surgery, but the between-group difference in improvement did not reach the minimal clinically important difference.
The investigator-initiated, open-label AirGOs Operative randomized controlled trial, published in Allergy, compared full and limited functional endoscopic sinus surgery (FESS) at two tertiary centers in Finland. Investigators hypothesized that full FESS would produce superior outcomes at 12 and 24 months, with change in the 22-item Sino-Nasal Outcome Test (SNOT-22) serving as the primary outcome.
Investigators screened 1,885 patients and randomized 97 between October 2018 and October 2022. Eligible patients were aged 18 to 65 years and had severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) despite at least 3 months of fluticasone drops and nasal lavage. Inclusion also required a SNOT-22 score of at least 30, bilateral nasal polyp score of at least 4, Lund-Mackay radiologic score of at least 14, and at least 1 previous sinus surgery, 1 or more oral corticosteroid courses within 2 years, or at least 3 antibiotic courses within 2 years.
Full FESS involved opening the maxillary sinuses, navigator-assisted complete ethmoidectomy, sphenotomy, and Draf 2a frontal opening under general anesthesia. Limited FESS consisted of uncinectomy, enlargement of the maxillary sinus opening, and partial ethmoidectomy, with optional opening of the ground lamella, and was preferably performed under local anesthesia. Among patients assigned to limited FESS, 63% underwent surgery under local anesthesia.
The trial was powered at 80% to detect a 9-point between-group difference in the change in SNOT-22 scores from preoperative assessment to 12 months. Primary analyses were conducted per protocol using linear mixed-effects models, which accounted for repeated measurements over time. The investigators reported that results remained consistent across comparisons when analyses were performed using an intention-to-treat approach.
At baseline, mean SNOT-22 scores were 53 in the full FESS group and 57 in the limited FESS group. At 12 months, mean scores decreased to 22 and 32, respectively, corresponding to improvements of approximately 30 and 25 points from before surgery. At 24 months, mean scores were 25 and 28, corresponding to improvements of approximately 27 and 29 points from before surgery.
Mean SNOT-22 scores decreased at 12 and 24 months in both groups, with improvements exceeding the 8.9-point minimal clinically important difference. However, the difference in SNOT-22 change between the groups did not reach the clinically meaningful threshold at either 12 or 24 months.
Nasal polyp scores decreased in both groups but improved more following full FESS over the follow-up period and at 12 months. Olfactory function also improved in both groups, with greater recovery from anosmia following full FESS at 12 months and over the 24-month follow-up.
“Better control of inflammation after full FESS may influence the need for revision surgery or the long-term maintenance of olfaction,” wrote lead author Paula Virkkula of the Department of Otorhinolaryngology—Head and Neck Surgery at Helsinki University Hospital, and University of Helsinki, in Finland, and colleagues.
At 12 months, 41% of patients in the full FESS group had anosmia compared with 76% in the limited FESS group. At 24 months, the proportions were 54% and 61%, respectively. The investigators noted that the 12-odor smell test used in the trial is a screening test and does not include threshold or discrimination.
Peak nasal inspiratory flow improved similarly in both groups and reached the minimal clinically important difference at 12 and 24 months. The number of oral corticosteroid courses also decreased in both groups during the 24-month follow-up compared with the preoperative year.
Ten patients required a change in treatment because of loss of disease control during follow-up. Eight patients assigned to limited FESS underwent or were scheduled for revision surgery, 1 was scheduled to start biologic therapy, and 1 patient assigned to full FESS was scheduled for biologic therapy. The investigators stated that the small number of events did not support firm conclusions regarding subsequent treatment requirements.
The investigators identified several limitations. Masking was not possible and may have influenced outcomes reported by patients and surgeons. The findings were primarily applicable to patients with moderate to severe, uncontrolled eosinophilic chronic rhinosinusitis with nasal polyps requiring surgery; the cohort mainly had type 2 inflammation and a high prevalence of asthma and nonsteroidal anti-inflammatory drug-exacerbated respiratory disease. The investigators also noted that physician contact every 3 months may have influenced patients’ understanding of self-medication, and that the findings should also be evaluated in a real-world setting. The investigators noted that the 24-month follow-up was insufficient to address all considerations in selecting between full and limited FESS and that patients at risk for repeat surgery or biologic treatment require longer follow-up.
Overall, the study shows substantial improvement in disease-specific quality of life following either full or limited FESS in this selected population. Full FESS was associated with greater recovery from anosmia and lower polyp burden, particularly during the first postoperative year. However, the improvement in quality of life did not differ between the groups by a clinically meaningful amount.
Disclosures: The study received research grant support from the Tampere Tuberculosis Foundation, Finnish ORL-HNS Foundation, Paulo Foundation, Ahokas Foundation, Finnish Society of Allergology and Immunology, Foundation of the Finnish Anti-Tuberculosis Association, state funding of university-level health research, Finnish Rhinology Society, Väinö and Laina Kivi Foundation, and Research Foundation of the Pulmonary Diseases. The funders had no role in the study design, data collection, analysis, interpretation, or preparation of the report. Full disclosures can be found in the published study.
Source: Allergy
