Ethmoid Drug‐Eluting Catheter for Nasosinusal Polyposis: Results after a Randomized Controlled Trial

Autor: Gustavo Eisenberg, Elizabeth A. Espitia, Guillermo Plaza, José Montojo, Victoria García-Peces, Estefanía Hernández-García, Maria Urbasos Pascual
Rok vydání: 2014
Předmět:
Zdroj: Otolaryngology–Head and Neck Surgery. 151
ISSN: 1097-6817
0194-5998
DOI: 10.1177/0194599814541627a282
Popis: 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 pati...
Databáze: OpenAIRE