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Clinical Trials/NCT05979662
NCT05979662
Recruiting
Not Applicable

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

Ibrahim Talal Elshamy2 sites in 1 country50 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endoscopic Frontal Sinus Surgery
Sponsor
Ibrahim Talal Elshamy
Enrollment
50
Locations
2
Primary Endpoint
Recurrence of polyp using endoscopic polyp score
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ibrahim Talal Elshamy
Responsible Party
Sponsor Investigator
Principal Investigator

Ibrahim Talal Elshamy

Assistant Lecturer of Otorhinolaryngology

Tanta University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Recurrence of polyp using endoscopic polyp score

Time Frame: 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 Outcomes

  • Lund MacKay score(One year postoperatively)
  • Sinonasal Outcome Test- 22(One year postoperatively)

Study Sites (2)

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