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UnknownNCT05979662

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Ibrahim Talal Elshamy · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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).

Timeline

Start date
2021-01-01
Primary completion
2023-09-30
Completion
2023-09-30
First posted
2023-08-07
Last updated
2023-08-07

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05979662. Inclusion in this directory is not an endorsement.