Chronic sinusitis
Conditions
Interventions
Postoperative implantation group:After functional endoscopic sinus surgery (FESS), the nasal cavity is packed intraoperatively with absorbable hemostatic material. At 1–2 weeks postoperatively (first
Intraoperative Implantation Group:During functional endoscopic sinus surgery(FESS), biodegradable drug-eluting sinus stents were implanted into the bilateral sinus cavities intraoperatively.
Sponsors
Ethics Committee of the Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. All patients must meet the diagnostic criteria for chronic rhinosinusitis (CRS) according to EPOS 2020, and must have bilateral CRS with a Lund–Mackay CT score >= 4 on each side. 2. Poor response after at least 12 weeks of medical therapy (including intranasal corticosteroid spray as prescribed, combined or not combined with =2 weeks of oral anti-inflammatory drugs, antihistamines, nasal saline irrigation, mucolytic agents, etc.). 3. Patients must have a clear intention to undergo surgery, meet the surgical indications for CRS, and have no contraindications to CRS surgery. 4. Able to complete questionnaires independently or with the guidance of healthcare professionals. 5. Demonstrate good compliance and willingness to complete the full course of clinical observation.
Exclusion criteria
Exclusion criteria: 1. Known allergy or contraindication to the biodegradable sinus drug-eluting stent or its degradation products (mometasone furoate, poly-L-lactic acid, poly-DL-lactic acid, polylactide-co-glycolide, or lactic acid). 2. Corticosteroid-dependent patients, or those currently under immunosuppressive therapy, or known to have immunodeficiency or autoimmune diseases. 3. History of ocular diseases such as glaucoma or cataract. 4. Acute rhinosinusitis or invasive fungal sinusitis indicated preoperatively, or concurrent acute upper respiratory infection or other severe infectious diseases. 5. Clinical evidence of orbital or intracranial complications. 6. Severe diabetes mellitus, or severe underlying cardiovascular, pulmonary, hematologic, or other systemic diseases that may affect surgery. 7. Presence of psychiatric disorders or poor compliance. 8. Contraindication to general anesthesia. 9. Other conditions deemed unsuitable for study participation by the investigators. 10. Use of biological agents within 12 weeks before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lund–Kennedy endoscopic scoring system; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokine detection in nasal secretions; | — |
Countries
China
Contacts
Public ContactHuankang Zhang
Eye & ENT Hospital, Fudan University
Outcome results
None listed