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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group one | Experimental | Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III). |
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| Group two | Active Comparator | Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic frontal sinus surgery grade 6(Draf III). | Procedure | Patients will receive endoscopic frontal sinus surgery grade 6(Draf III). |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of polyp using endoscopic polyp score | 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 | One year postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Lund MacKay score | 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). | One year postoperatively |
| Sinonasal Outcome Test- 22 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibrahim T Elshamy, MSc | Contact | +20 102 237 3920 | hematalal93@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | El-Gharbia | 31511 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
after the end of study for one year.
The data will be available upon a reasonable request from the corresponding autho
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| Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa) | Procedure | Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa). |
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SNOT- 22 was measured based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems |
| One year postoperatively |
| Tanta University | Recruiting | Tanta | El-Gharbia | 31511 | Egypt |
|