Comparison of Bioabsorbable Steroid-Eluting Sinus Stents Versus Nasopore After Endoscopic Sinus Surgery: A Multicenter, Randomized, Controlled, Single-Blinded Clinical Trial
机构:[1]Capital Med Univ, Beijing Tongren Hosp, Dept Otolaryngol Head & Neck Surg, Beijing 100730, Peoples R China临床科室耳鼻咽喉-头颈外科首都医科大学附属北京同仁医院首都医科大学附属同仁医院[2]Fudan Univ, Eye Ear Nose & Throat Hosp, Dept Otolaryngol Head & Neck Surg, Shanghai, Peoples R China[3]Zhejiang Univ, Affiliated Hosp 1, Coll Med, Dept Otolaryngol Head & Neck Surg, Hangzhou, Zhejiang, Peoples R China浙江大学医学院附属第一医院[4]Jiangsu Prov Hosp, Dept Otolaryngol Head & Neck Surg, Nanjing, Jiangsu, Peoples R China江苏省人民医院[5]Peoples Liberat Army Gen Hosp, Dept Otolaryngol Head & Neck Surg, Med Ctr 6, Beijing, Peoples R China[6]Soochow Univ, Dept Otolaryngol Head & Neck Surg, Affiliated Hosp 1, Suzhou, Jiangsu, Peoples R China[7]Tianjin Med Univ, Dept Otolaryngol Head & Neck Surg, Gen Hosp, Tianjin, Peoples R China[8]Emergency Gen Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
Objectives: The aim of this study was to compare the efficacy of bioabsorbable steroid-eluting sinus stents versus absorbable Nasopore packs after endoscopic sinus surgery (ESS) for the treatment of chronic rhinosinusitis (CRS). Methods: One hundred eighty-one patients with CRS who underwent ESS were randomly assigned to receive a steroid-eluting sinus stent in one ethmoid sinus cavity, whereas the contralateral control side received a Nasopore pack. Endoscopic evaluations were performed 14, 30, and 90 days after the ESS. Postoperative intervention, polyp formation, adhesions, and middle turbinate (MT) position were assessed as efficacy outcomes. Results: The stents were successfully deployed in all 181 sinuses. Thirty days after the ESS, the stents significantly reduced the need for surgical intervention compared to the Nasopore (P < .0001). The percentage of cases with polyp formation was significantly lower on the stent sides compared with the Nasopore sides (P < .0001) at 14, 30, and 90 days after ESS. The percentage of severe adhesion was significantly lower on the stents sides than on the Nasopore sides at postoperative day 90 (P = .0003), whereas they were not significantly lower at postoperative days 14 and 30. There were no significant differences between the stent sides and the Nasopore sides regarding the frequency of MT lateralization at all end points. No device-related adverse events occurred. Conclusions: Our study demonstrated significant improvement in the early postoperative outcomes by reducing the need for postoperative surgical intervention and polyp formation using steroid-eluting stents when compared with absorbable Nasopore packs. The steroid-eluting sinus stents and the Nasopore packs were each effective in preserving the ethmoid sinus patency and in preventing MT lateralization. A further prospective cohort study with long-term postoperative outcomes is warranted.
基金:
National Natural Science Foundation of China [81770977]