Abstract
Objectives: Assess the safety and efficacy of a drug-eluting catheter to be inserted into the ethmoid sinuses during endoscopic sinus surgery to elute triamcinolone in patients with CRSwP (nasosinusal polyposis). Methods: Prospective, randomized, controlled, double-blind, clinical trial using intrapatient control design. The study enrolled 40 patients with CRSwP undergoing endoscopic sinus surgery. In every case, after polypectomy was done to expose the ethmoid bulla, a drug-eluting catheter to elute triamcinolone (0.3 mL) was randomly applied to one nasal fossa, whereas the other was treated by conventional total ethmoidectomy. Outcome measures were visual analogue scales, Rhinosinusitis Disability Index, endoscopy, and olfactometry assessment at baseline, 3, 6, and 12 months. Safety assessments included ocular examinations at baseline and 30 days. All CT imaging was done after more than 12 months of follow-up. Results: After randomization was performed, unilateral devices were successfully placed in all patients and easily removed after 4 weeks. When comparing both nasal fossae in postoperative endoscopies at 6 and 12 months, the prevalence of edema, adhesions, and recurrent polyposis were statistically similar. Changes from baseline in patient-reported outcomes were statistically relevant in both sides. No clinically important changes in intraocular pressure occurred. CT resolution of pathology was achieved in both sides, improving Lund-Mackay scale, without significant differences. Conclusions: This trial provides clinical evidence on the safety and efficacy of a drug-eluting catheter for use in patients with CRSwP. It achieves similar results compared to complete ethmoidectomy, without any major complications.
Published Version
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