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

Not Applicable

Recruiting

• Conditions: Endoscopic Frontal Sinus Surgery; Draf I or IIa; Draf III; Chronic Rhinosinusitis With Nasal Polyps
• Interventions: Procedure: Endoscopic frontal sinus surgery grade 6(Draf III).; Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)

• Registration Number: NCT05979662
• Lead Sponsor: Ibrahim Talal Elshamy

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-29
• Study First Submitted QC: 2023-07-29
• Last Update Submitted: 2023-07-29
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group one	Endoscopic frontal sinus surgery grade 6(Draf III).	Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III).
Group two	Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)	Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Tanta University Hospitals; 🇪🇬 Tanta, El-Gharbia, Egypt

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt