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

Last updated: July 29, 2023
Sponsor: Ibrahim Talal Elshamy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polyps

Sinusitis

Rhinitis, Allergic, Perennial

Treatment

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

Endoscopic frontal sinus surgery grade 6(Draf III).

Clinical Study ID

NCT05979662
34417/1/21
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps whofailed appropriate medical treatment in the form of antibiotic, systemic and localcorticosteroid for 3 months .

Exclusion

Exclusion Criteria:

  • Narrow anteroposterior diameter of frontal sinus ostium(1cm or less)
  • Patients showing less or highest degree of radiological complexity of surgery onstudying the Computed Tomography.
  • Any contraindication for general anesthesia.
  • Patients below age of 18 years.
  • Incomplete follow up
  • previous sinus surgery

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
September 30, 2023

Study 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.

Connect with a study center

  • Tanta University

    Tanta, El-Gharbia 31511
    Egypt

    Active - Recruiting

  • Tanta University Hospitals

    Tanta, El-Gharbia 31511
    Egypt

    Active - Recruiting

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