Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening

Timothy Smith, Ameet Singh, Amber Luong, Randall A. Ow, Steven D. Shotts, Nathan Sautter, Joseph K. Han, James Stambaugh, Aarthi Raman

Research output: Contribution to journalArticle

21 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)2659-2664
Number of pages6
JournalLaryngoscope
Volume126
Issue number12
DOIs
StatePublished - Dec 1 2016

Fingerprint

Frontal Sinus
Randomized Controlled Trials
Steroids
Research Personnel
Laryngoscopes
Postoperative Care
Prospective Studies
Inflammation
Safety

Keywords

  • absorbable implant
  • Corticosteroid
  • frontal sinus
  • frontal sinusotomy
  • functional endoscopic sinus surgery (FESS)
  • inflammation
  • mometasone furoate
  • polyposis

ASJC Scopus subject areas

  • Otorhinolaryngology

Cite this

Smith, T., Singh, A., Luong, A., Ow, R. A., Shotts, S. D., Sautter, N., ... Raman, A. (2016). Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope, 126(12), 2659-2664. https://doi.org/10.1002/lary.26140

Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. / Smith, Timothy; Singh, Ameet; Luong, Amber; Ow, Randall A.; Shotts, Steven D.; Sautter, Nathan; Han, Joseph K.; Stambaugh, James; Raman, Aarthi.

In: Laryngoscope, Vol. 126, No. 12, 01.12.2016, p. 2659-2664.

Research output: Contribution to journalArticle

Smith, T, Singh, A, Luong, A, Ow, RA, Shotts, SD, Sautter, N, Han, JK, Stambaugh, J & Raman, A 2016, 'Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening', Laryngoscope, vol. 126, no. 12, pp. 2659-2664. https://doi.org/10.1002/lary.26140
Smith, Timothy ; Singh, Ameet ; Luong, Amber ; Ow, Randall A. ; Shotts, Steven D. ; Sautter, Nathan ; Han, Joseph K. ; Stambaugh, James ; Raman, Aarthi. / Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. In: Laryngoscope. 2016 ; Vol. 126, No. 12. pp. 2659-2664.
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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.",
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