Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up

Abstract

Background: This study evaluated 1-year outcomes in patients with chronic rhinosinusitis (CRS) who were considered surgical candidates by study criteria and elected either medical management or endoscopic sinus surgery (ESS). In addition, some patients initially enrolled in the medical treatment arm crossed over to the surgery arm during the study period and their respective outcomes are evaluated.

Methods: Adult subjects with CRS who failed initial medical therapy were prospectively enrolled into a nonrandomized, multi-institutional cohort. Subjects were included in 1 of 3 cohorts: medically managed, surgically managed, or crossover (from medical to surgical). The primary outcome measure was disease-specific quality-of-life (QOL). Bivariate and multivariate analyses compared QOL improvement between cohort groups.

Results: Baseline comorbidity, QOL, and other disease severity measures were not different between the 3 cohorts. With 1-year follow up, surgical patients (n = 65) reported significantly more improvement than medically managed patients (n = 33; Rhinosinusitis Disability Index (RSDI), p = 0.039; Chronic Sinusitis Survey (CSS), p = 0.018). Seventeen subjects who had initially elected medical management crossed over to surgery during the follow-up period. QOL in the crossover cohort was initially stagnant or worsening followed by improvement after ESS (RSDI, p = 0.035; CSS, p = 0.070). At 1-year follow-up, higher frequency of improvement was found in the surgical cohort vs medical cohort for several outcomes (total CSS: 70.8% vs 45.5%; odds ratio [OR], 3.37; 95% confidence interval [CI], 1.27-8.90; p = 0.014).

Conclusion: With 1 year of follow-up, patients electing ESS experienced significantly higher levels of improvement in outcomes compared to patients managed by medication alone. In addition, a crossover cohort who initially elected medical management experienced improvement in several outcomes after crossing over to ESS.

Trial registration: ClinicalTrials.gov NCT01255566.