Timothy L Smith1, Ameet Singh2, Amber Luong3, Randall A Ow4, Steven D Shotts5, Nathan B Sautter6, Joseph K Han7, James Stambaugh8, Aarthi Raman8. 1. Department of Otolaryngology-Head and Neck Surgery, Oregon Health Sciences University, Portland, Oregon, U.S.A. 2. Department of Surgery and Neurosurgery, George Washington Medical Faculty Associates, Washington, DC, U.S.A. 3. Department of Otorhinolaryngology, McGovern Medical School at the University of Texas Health Science Center of Houston, Houston, Texas, U.S.A. 4. Sacramento ENT, Roseville, California, U.S.A. 5. Advanced ENT and Allergy, Louisville, Kentucky, U.S.A. 6. Providence St. Vincent Medical Center, Portland, Oregon, U.S.A. 7. Divisions of Rhinology and Endoscopic Sinus-Skull Base Surgery and Allergy, Eastern Virginia Medical School, Norfolk, Virginia, U.S.A. 8. Intersect ENT, Menlo Park, California, U.S.A.
Abstract
OBJECTIVES/HYPOTHESIS: To assess safety and efficacy of a steroid-releasing implant in improving surgical outcomes when placed in the frontal sinus opening (FSO) following endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS). STUDY DESIGN: Prospective, multicenter, randomized, blinded trial using an intrapatient control design. METHODS:Eighty adult (≥ 18 years) CRS patients who underwent successful bilateral frontal sinusotomy were randomized to receive a steroid-releasing implant in one FSO, whereas the contralateral control side received no implant. All patients received standard postoperative care. Endoscopic evaluations recorded at 30-days postendoscopic sinus surgery (ESS) were graded real time by clinical investigators and by an independent, blinded sinus surgeon to assess the need for postoperative interventions in the FSO. RESULTS: Implants were successfully placed in all 80 frontal sinuses, resulting in 100% implant delivery success. At 30-days post-ESS, steroid-releasing implants provided a statistically significant (P = 0.0070) reduction in the need for postoperative interventions compared to surgery alone by an independent reviewer, representing 38% relative reduction. Clinical investigators reported statistically significant reduction in this measure at 30 days (P < 0.0001) and 90 days (P = 0.0129). Clinical investigators also reported a 55.6% reduction in the need for oral steroid interventions (P = 0.0015), 75% reduction in the need for surgical interventions (P = 0.0225), 16.7% reduction in inflammation score, 54.3% reduction in restenosis rate (P = 0.0002), and 32.2% greater diameter of FSO (P < 0.0001) on treated sides compared to control at 30 days. No implant-related adverse events were reported. CONCLUSION: This study demonstrates the efficacy of steroid-releasing implants in improving outcomes of frontal sinus surgery. LEVEL OF EVIDENCE: 1b. Laryngoscope, 126:2659-2664, 2016.
RCT Entities:
OBJECTIVES/HYPOTHESIS: To assess safety and efficacy of a steroid-releasing implant in improving surgical outcomes when placed in the frontal sinus opening (FSO) following endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS). STUDY DESIGN: Prospective, multicenter, randomized, blinded trial using an intrapatient control design. METHODS: Eighty adult (≥ 18 years) CRSpatients who underwent successful bilateral frontal sinusotomy were randomized to receive a steroid-releasing implant in one FSO, whereas the contralateral control side received no implant. All patients received standard postoperative care. Endoscopic evaluations recorded at 30-days postendoscopic sinus surgery (ESS) were graded real time by clinical investigators and by an independent, blinded sinus surgeon to assess the need for postoperative interventions in the FSO. RESULTS: Implants were successfully placed in all 80 frontal sinuses, resulting in 100% implant delivery success. At 30-days post-ESS, steroid-releasing implants provided a statistically significant (P = 0.0070) reduction in the need for postoperative interventions compared to surgery alone by an independent reviewer, representing 38% relative reduction. Clinical investigators reported statistically significant reduction in this measure at 30 days (P < 0.0001) and 90 days (P = 0.0129). Clinical investigators also reported a 55.6% reduction in the need for oral steroid interventions (P = 0.0015), 75% reduction in the need for surgical interventions (P = 0.0225), 16.7% reduction in inflammation score, 54.3% reduction in restenosis rate (P = 0.0002), and 32.2% greater diameter of FSO (P < 0.0001) on treated sides compared to control at 30 days. No implant-related adverse events were reported. CONCLUSION: This study demonstrates the efficacy of steroid-releasing implants in improving outcomes of frontal sinus surgery. LEVEL OF EVIDENCE: 1b. Laryngoscope, 126:2659-2664, 2016.
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