Proven medical research regarding balloon sinuplasty and other sinus procedures
Objective. To develop a clinical consensus statement on the use of sinus ostial dilation (SOD) of the paranasal sinuses.
Methods. An expert panel of otolaryngologists was assembled to represent general otolaryngology and relevant subspecialty societies. The target population is adults 18 years or older with chronic or recurrent rhinosinusitis (with or without nasal polyps, with or without prior sinus surgery) for whom SOD is being recommended, defined as endoscopic use of a balloon device to enlarge or open the outflow tracts of the maxillary, frontal, or sphenoid sinuses, as a standalone procedure or with endoscopic surgery. A modified Delphi method was used to distill expert opinion into clinical statements that met a standardized definition of consensus. [...]
Safety and Effectiveness ofa Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia
A Randomized Clinical Trial
IMPORTANCE Suboptimal outcomes of endoscopic sinus surgery (ESS) are often associated with restenosis and inflammation of frontal sinus ostia. Steroid-releasing sinus implants have been shown to maintain sinus patency by minimizing inflammation and scar tissue formation. An hourglass-shaped, bioabsorbable, steroid-releasing implant was developed to provide mechanical support and optimize drug delivery to paranasal sinus ostia.
OBJECTIVE To assess the safety and efficacy of the hourglass-shaped, bioabsorbable, steroid-releasing sinus implant in improving postoperative outcomes when placed in the frontal sinus ostia (FSO) following ESS in patients with chronic rhinosinusitis (CRS).
DESIGN, SETTING, AND PARTICIPANTS In a prospective, multicenter, randomized clinical trial using an intrapatient control design (ESS followed by implant placement within 1 FSO vs ESS alone on the contralateral side) 80 adult patients, with a mean (SD) age of 49.5 (13.4) years and consisting of53 (66%) men and 27 (34%) women, were enrolled and underwent bilateral frontal sinusotomies With 1 frontal sinus randomized to receive a steroid-releasing implant. The study was carried out in 12 US centers between July 2015 and March 2016.
INTERVENTIONS A bioabsorbable steroid-releasing implant with hourglass shape containing 370 µg of mometasone furoate. All patients received standardized postoperative care. [...]
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