Endoscopic Frontal Sinus Surgery Draf III in Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of Primary Endoscopic Frontal Sinus Surgery Grade 6 (Draf III) in Patients With Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps

Conditions
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Endoscopic Frontal Sinus Surgery, Chronic Rhinosinusitis With Nasal Polyps, Draf III, Draf I or IIa

Intervention / Treatment
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* Procedure: Endoscopic frontal sinus surgery grade 6(Draf III).
* Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group one<br>Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III). | Procedure: Endoscopic frontal sinus surgery grade 6(Draf III).<br>* Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).<br>|
| Active Comparator: Group two<br>Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa). | Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)<br>* Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |