Background <p>The frontal sinus is among the most anatomically complex regions to manage in endoscopic sinus surgery, with high risks of postoperative restenosis. This study aimed to evaluate the safety and efficacy of biodegradable, drug-eluting stents (Propel) compared to traditional non-drug-eluting stents (Merocel and Rains) in maintaining frontal sinus ostium patency following functional endoscopic sinus surgery (FESS).</p> Methods <p>A prospective comparative study was conducted at Helwan University Hospital (Badr Hospital), enrolling 34 adult patients with various frontal sinus pathologies at high risk of restenosis. Participants were randomized into two groups: the study group (<i>n</i> = 17) received the Propel stent, while the control group (<i>n</i> = 17) received either Merocel or Rains stents. Patients were followed for 6 months postoperatively with clinical, endoscopic, and radiological assessments. Primary outcomes included frontal ostium patency, while secondary outcomes assessed complications such as stenosis, obstruction, adhesions, polyp formation, mucosal healing, and inflammation.</p> Results <p>Baseline characteristics and surgical indications were comparable between groups. At 6 months, the Propel group demonstrated significantly higher ostium patency (100% vs. 41.18%, <i>p</i> = 0.001), a complete absence of adhesions (0% vs. 58.82%, <i>p</i> = 0.001), and lower rates of polyp formation (0% vs. 23.53%, <i>p</i> = 0.033). Sinonasal mucosal healing was higher in the Propel group (94.12% vs. 76.47%, <i>p</i> = 0.168), though not statistically significant. Trends toward reduced inflammation and retained secretions favored the Propel group. All Propel stents were entirely absorbed by 6 months without the need for removal.</p> Conclusion <p>Biodegradable drug-eluting Propel stents significantly improve postoperative outcomes in frontal sinus surgery by enhancing ostium patency, reducing adhesions and polyp recurrence, and promoting mucosal healing. These findings support the selective use of drug-eluting stents in high-risk patients; however, larger multicenter trials with longer follow-up are needed to confirm the long-term benefits.</p>

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Effectiveness of biodegradable drug-eluting frontal sinus stents as adjuvant therapy during functional endoscopic sinus surgery

  • Mohamed Mahmoud ElSheikh,
  • Aly Ahmed Elgarem,
  • Hossameldin Mosa Sharaf,
  • Mohamed G. Hamid,
  • Ahmed Mohamed Medhat ElShafei

摘要

Background

The frontal sinus is among the most anatomically complex regions to manage in endoscopic sinus surgery, with high risks of postoperative restenosis. This study aimed to evaluate the safety and efficacy of biodegradable, drug-eluting stents (Propel) compared to traditional non-drug-eluting stents (Merocel and Rains) in maintaining frontal sinus ostium patency following functional endoscopic sinus surgery (FESS).

Methods

A prospective comparative study was conducted at Helwan University Hospital (Badr Hospital), enrolling 34 adult patients with various frontal sinus pathologies at high risk of restenosis. Participants were randomized into two groups: the study group (n = 17) received the Propel stent, while the control group (n = 17) received either Merocel or Rains stents. Patients were followed for 6 months postoperatively with clinical, endoscopic, and radiological assessments. Primary outcomes included frontal ostium patency, while secondary outcomes assessed complications such as stenosis, obstruction, adhesions, polyp formation, mucosal healing, and inflammation.

Results

Baseline characteristics and surgical indications were comparable between groups. At 6 months, the Propel group demonstrated significantly higher ostium patency (100% vs. 41.18%, p = 0.001), a complete absence of adhesions (0% vs. 58.82%, p = 0.001), and lower rates of polyp formation (0% vs. 23.53%, p = 0.033). Sinonasal mucosal healing was higher in the Propel group (94.12% vs. 76.47%, p = 0.168), though not statistically significant. Trends toward reduced inflammation and retained secretions favored the Propel group. All Propel stents were entirely absorbed by 6 months without the need for removal.

Conclusion

Biodegradable drug-eluting Propel stents significantly improve postoperative outcomes in frontal sinus surgery by enhancing ostium patency, reducing adhesions and polyp recurrence, and promoting mucosal healing. These findings support the selective use of drug-eluting stents in high-risk patients; however, larger multicenter trials with longer follow-up are needed to confirm the long-term benefits.