Chronic Rhinosinusitis With Nasal Polyps, Draf III, Draf I or IIa, Endoscopic Frontal Sinus Surgery
Conditions
Brief summary
The aim of this study is to evaluate the effect of the primary endoscopic frontal sinus surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using endoscopic polyp score and Secondary outcome measures include Lund MacKay score, SNOT-22 and need for corticosteroid to control polyp postoperatively.
Detailed description
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common inflammatory disorder, affecting about 4% of the population worldwide and strongly impacts the quality of life of affected patient. Eosinophilic chronic rhinosinusitis (ECRS) is a subtype of recalcitrant Chronic rhinosinusitis . Patients with ECRS and generally having a tissue eosinophil \>10 cells per high power field (HPF), have worse disease severity and poorer treatment outcomes compared to non-Eosinophilic chronic rhinosinusitis.
Interventions
PROCEDUREEndoscopic frontal sinus surgery grade 6(Draf III).
Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).
PROCEDUREEndoscopic frontal sinus surgery grade 1-3(Draf I or IIa)
Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).
Sponsors
Ibrahim Talal Elshamy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who failed appropriate medical treatment in the form of antibiotic, systemic and local corticosteroid for 3 months .
Exclusion criteria
* Narrow anteroposterior diameter of frontal sinus ostium(1cm or less) * Patients showing less or highest degree of radiological complexity of surgery on studying the Computed Tomography. * Any contraindication for general anesthesia. * Patients below age of 18 years. * Incomplete follow up * previous sinus surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of polyp using endoscopic polyp score | One year postoperatively | Polyps were evaluated on each side through nasal endoscopy at each visit and graded based on polyp size, resulting in scores of 0 to 4 9. Zero is no polyp, 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = polyps reaching below the lower border of the middle turbinate, 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = large polyps causing complete obstruction of the inferior nasal cavity. The sum of the left and right nostril scores is the Nasal Polyp Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lund MacKay score | One year postoperatively | The Lund-Mackay staging system scores each sinus (anterior ethmoid, posterior ethmoid, maxillary, frontal, and sphenoid sinuses) according to the following scale: 0 (no opacification), 1 (partial opacification), or 2 (complete opacification). |
| Sinonasal Outcome Test- 22 | One year postoperatively | SNOT- 22 was measured based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems |
Countries
Egypt
Contacts
Primary ContactIbrahim T Elshamy, MSc
Outcome results
None listed