Jon F Dautremont1, Brad Mechor, Luke Rudmik. 1. Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.
Abstract
OBJECTIVE:Steroid-eluting spacers can improve local drug delivery immediately following endoscopic sinus surgery and reduce the recurrence of inflammation warranting systemic corticosteroids. For chronic rhinosinusitis with nasal polyposis, the need for systemic corticosteroids immediately following endoscopic sinus surgery when using a steroid-eluting spacer has not been studied. STUDY DESIGN: A randomized, double-blind, placebo-controlled trial. SETTING: Academic rhinology practice. SUBJECTS AND METHODS: Chronic rhinosinusitis patients with nasal polyposis who failed medical therapy and elected endoscopic sinus surgery were enrolled. Patients were randomized into either the treatment arm (postoperative prednisone 30 mg daily × 7 days; n = 18) or placebo arm (postoperative placebo pill daily × 7 days; n = 18). Outcomes were evaluated at 1 week, 3 weeks, and 2 months postoperatively. Primary outcome was endoscopic grading at postoperative month 2 using the Lund-Kennedy system. Secondary outcome included disease-specific quality of life using the Sinonasal Outcome Test (SNOT-22) survey. Patient enrollment occurred from January 2012 through February 2013 (NCT01564355). RESULTS: Both arms received significant improvement in endoscopic grading and disease-specific quality of life from baseline compared to 2-month follow-up (P < .001). There were no significant differences in mean endoscopic scores between the postoperative prednisone and control groups at 1 week (P = .715), 3 weeks (P = .883), or 2 months (P = .343). There were no significant differences in SNOT-22 scores between groups at all follow-up points (all P > .119). CONCLUSION: Minimizing systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyposis may avoid adverse events. Results from this study suggest that postoperative systemic corticosteroids immediately following endoscopic sinus surgery may not provide improved outcomes when utilizing a steroid-eluting spacer.
RCT Entities:
OBJECTIVE:Steroid-eluting spacers can improve local drug delivery immediately following endoscopic sinus surgery and reduce the recurrence of inflammation warranting systemic corticosteroids. For chronic rhinosinusitis with nasal polyposis, the need for systemic corticosteroids immediately following endoscopic sinus surgery when using a steroid-eluting spacer has not been studied. STUDY DESIGN: A randomized, double-blind, placebo-controlled trial. SETTING: Academic rhinology practice. SUBJECTS AND METHODS: Chronic rhinosinusitispatients with nasal polyposis who failed medical therapy and elected endoscopic sinus surgery were enrolled. Patients were randomized into either the treatment arm (postoperative prednisone 30 mg daily × 7 days; n = 18) or placebo arm (postoperative placebo pill daily × 7 days; n = 18). Outcomes were evaluated at 1 week, 3 weeks, and 2 months postoperatively. Primary outcome was endoscopic grading at postoperative month 2 using the Lund-Kennedy system. Secondary outcome included disease-specific quality of life using the Sinonasal Outcome Test (SNOT-22) survey. Patient enrollment occurred from January 2012 through February 2013 (NCT01564355). RESULTS: Both arms received significant improvement in endoscopic grading and disease-specific quality of life from baseline compared to 2-month follow-up (P < .001). There were no significant differences in mean endoscopic scores between the postoperative prednisone and control groups at 1 week (P = .715), 3 weeks (P = .883), or 2 months (P = .343). There were no significant differences in SNOT-22 scores between groups at all follow-up points (all P > .119). CONCLUSION: Minimizing systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyposis may avoid adverse events. Results from this study suggest that postoperative systemic corticosteroids immediately following endoscopic sinus surgery may not provide improved outcomes when utilizing a steroid-eluting spacer.