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

Ibrahim Talal Elshamy

Status: Enrolling

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

Treatments: Procedure: Endoscopic frontal sinus surgery grade 6(Draf III).; Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)

Study type: Interventional

Funder types: Other

Identifiers

NCT05979662

34417/1/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Group one

Experimental group

Description:

Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III).

Treatment:

Procedure: Endoscopic frontal sinus surgery grade 6(Draf III).

Group two

Active Comparator group

Description:

Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).

Treatment:

Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)