Chronic Rhinosinusitis (CRS), Nasal Polyps, Postoperative Healing After Endoscopic Nasal Surgery
Conditions
Keywords
Triamcinolone acetonide, Nanocapsules, Polymeric nanocapsules, Endoscopic nasal surgery
Brief summary
This randomised, single-masked, parallel-group clinical trial will evaluate the efficacy and safety of a topical triamcinolone acetonide-loaded polymeric nanocapsule formulation for postoperative care following endoscopic nasal surgery. Participants will receive either the investigational triamcinolone acetonide-loaded nanocapsule formulation or standard normal saline nasal irrigation. Postoperative nasal healing, inflammation, patient-reported sinonasal symptoms, postoperative complications, and corticosteroid-related adverse effects will be compared between the two groups.
Detailed description
Postoperative care following functional endoscopic sinus surgery and other endoscopic nasal procedures is important for reducing inflammation, supporting mucosal healing, and preventing complications and disease recurrence. Conventional topical nasal treatments may be rapidly cleared from the nasal cavity, which may reduce their contact time with the postoperative nasal mucosa. The investigational formulation contains triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method. The nanocapsule delivery system is intended to improve local drug retention, enhance drug stability, and provide controlled release of triamcinolone acetonide at the postoperative nasal tissues. Eligible participants will be randomly assigned to receive either topical triamcinolone acetonide-loaded polymeric nanocapsules or standard normal saline nasal irrigation following endoscopic nasal surgery. Participants will be followed using endoscopic clinical assessments, patient-reported sinonasal symptom questionnaires, evaluation of postoperative complications, and monitoring for local or systemic corticosteroid-related adverse effects.
Interventions
DRUGTriamcinolone Acetonide-Loaded Polymeric Nanocapsules
Triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.
Participants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.
Sponsors
Deraya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants will be randomly assigned in parallel to receive either topical triamcinolone acetonide-loaded polymeric nanocapsules or standard normal saline nasal irrigation following endoscopic nasal surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 60 years. * Patients scheduled to undergo one of the following procedures: * Functional endoscopic sinus surgery * Endoscopic turbinoplasty * Endoscopic septoplasty * Diagnosis of chronic rhinosinusitis and/or nasal polyps requiring surgical intervention. * Ability and willingness to provide written informed consent. * Ability and willingness to comply with study treatment and scheduled follow-up visits.
Exclusion criteria
* Known hypersensitivity to triamcinolone acetonide. * Known hypersensitivity to any component of the polymeric nanocapsule formulation. * Systemic contraindication to corticosteroid therapy. * Active severe nasal or sinonasal infection at the time of enrollment or treatment. * Pregnancy or breastfeeding, if excluded in the approved protocol. * Uncontrolled diabetes mellitus, if corticosteroid exposure is considered clinically relevant. * Immunosuppression or use of immunosuppressive therapy. * Recent use of systemic or intranasal corticosteroids within the protocol-defined washout period. * Participation in another clinical trial. * Any medical or psychiatric condition that may interfere with informed consent, study treatment, or follow-up. * Inability to complete the required questionnaires or follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lund-Kennedy Endoscopic Score | Baseline, postoperative week 2, postoperative week 4, and postoperative month 3 | The Lund-Kennedy Endoscopic Score will be used to assess postoperative nasal mucosal healing and inflammation. The score ranges from 0 to 20 and is calculated by summing the scores for polyps, discharge, oedema, scarring, and crusting (each scored 0-2 on both the left and right sides). A total score of 0 indicates no disease, and a score of 20 indicates the most severe disease. Therefore, higher scores indicate a worse outcome |
| Change in 22-Item Sinonasal Outcome Test Score (SNOT-22) | Baseline, postoperative week 2, postoperative week 4, and postoperative month 3 | SNOT-22 will be used to assess participant-reported sinonasal symptoms and health-related quality of life. The total score ranges from 0 to 110 and is calculated by summing the scores for 22 individual items. Each item is rated from 0 ("No problem") to 5 ("Problem as bad as it can be"). A total score of 0 indicates no disease burden, and a score of 110 indicates the maximum disease burden. Therefore, higher scores indicate a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Complications | From the date of surgery through postoperative month 3 | The number and percentage of participants experiencing protocol-defined postoperative complications will be recorded. |
| Incidence of Corticosteroid-Related Adverse Events | From the first administration of study treatment through postoperative month 3 | The number and percentage of participants experiencing local or systemic adverse events considered related to topical triamcinolone acetonide will be recorded. |
Countries
Egypt
Contacts
CONTACTSally Mansour Helmy
CONTACTAliaa Gamal Hussein
PRINCIPAL_INVESTIGATORSally Mansour Helmy
Deraya University
Outcome results
None listed