Researchers suggested a new study that the intraoperative placement of a bioabsorbable steroid-releasing implant in the frontal sinus of a chronic rhinosinusitis patient, might improve outcomes when compared with surgery alone. This study was published in the journal JAMA Otolaryngology-Head and Neck Surgery.
Dr. Amber Luong of the University of Texas Health Science Center in Houston said, "The frontal sinus, despite meticulous surgery, is at risk for stenosis given its narrowed boundaries making up the natural outflow tract. However, the frontal sinus often is involved in the disease process and cannot be ignored."
Dr. Luong and colleagues conducted a multi-center randomized intrapatient-controlled trial to see if a bioabsorbable implant inserted into the frontal sinus ostia could improve postoperative outcomes.
Bilateral frontal sinusotomies were performed on 80 patients (mean age, 49.5; 66% men) with one sinus receiving the implant, who were followed-up for 3 months. Traditional frontal sinusotomies were conducted on 81% of patients with surgical instruments (about 53%) or surgical instruments and balloon dilation (about 29%), and 19% underwent frontal sinus balloon dilation alone.
A total of 149 ethmoidectomies (95% anterior, 91% posterior), 69 (86%) maxillary antrostomies, and 61 (76%) sphenoidotomies were performed. In all participants, the implant was placed successfully, and all the patients received standard postoperative care.
According to the assessment of an independent reviewer, the implants significantly reduced the need for postoperative interventions within the first 30 days to 11.5% compared with 32.8% for surgery alone.
Clinical investigators conducted a real-time endoscopic assessment at day 30 which showed significant mean reductions. A reduction in the postoperative intervention (by 17%), inflammation score (by 12.3 mm) and rate of frontal restenosis or occlusion (by 22.7%) on the side with the implant compared with the control side was noted.
At the end of day 90, the benefits were sustained with significant mean reductions of postoperative interventions (by 11.7%) and in restenosis and occlusion of the frontal ostium (by 17.4%) on the implant side. As observed, the implant was not related to any adverse events.
Dr. Luong said, "This study showed that placement of (the) implant in the frontal neo-ostium intraoperatively could significantly reduce the need for postoperative intervention such as high-dose oral steroids or surgical resection to address inflammation or scarring that is common in this region."
These interventions in sinus surgery clinically benefit the patient, as high-dose steroids can cause an interruption in sleep, affect mood, change eating habits and are linked to osteoporosis. In addition, surgical interventions are linked to cost and possibly additional scarring.
The intra-patient design of this study allowed better assessment of the sinus implant, which could be compared against one placebo. Moreover, this could be conducted with a standardized postoperative regimen consisting of saline irrigations, a 10-day course of an oral antibiotic and possible addition of intranasal steroid started 14 days after surgery in this study.
Dr. Luong concluded that "However, another possible comparator could be a placement of a non-absorbable stent, which is typically removed several weeks after surgery."