Effects of Chitodex with steroid on patients having sinus surgery for chronic rhinosinusitis
Phase 3
- Conditions
- Chronic rhinosinusitisRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12621001507875
- Lead Sponsor
- Yuresh Naidoo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
1. Patients with symptoms of chronic rhinosinusitis (nasal discharge, post-nasal drip, nasal obstruction, facial pain, pressure, anosmia) that have been persistent for great than 3 months AND
2. 18 years of age or over AND
3. Are able to give written informed consent AND
4. Are indicated to undergo endoscopic sinus surgery and willing AND
5. Can commit to return to clinic for 2 week, 6 week and 12 week post-operative endoscopic examination (as per standard of care)
Exclusion Criteria
1. Allergy to shellfish
2. Pregnancy or breastfeeding
3. Hepatitis or blood disorders
4. Allergy to steroids
5. COVID-19 positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frontal sinus ostium measurement assessed by direct visualisation using nasal endoscopy[Intra-operative (day 0), 2 weeks, 6 weeks, 12 weeks (primary timepoint) post-operative];Maxillary sinus ostium measurement assessed by direct visualisation using nasal endoscopy[Intra-operative (day 0), 2 weeks, 6 weeks, 12 weeks (primary timepoint) post-operative];Sphenoid sinus ostium measurement assessed by direct visualisation using nasal endoscopy[Intra-operative (day 0), 2 weeks, 6 weeks, 12 weeks (primary timepoint) post-operative]
- Secondary Outcome Measures
Name Time Method Post-operative prednisolone requirements as determined at post-operative in-person or telephone follow-up at 12 weeks[At the end of the 12 week post-operative period];Self-directed symptom based questionnaires (SNOT-22 questionnaire)[2 weeks, 6 weeks, 12 weeks post-operative]