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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ibrahim T Elshamy, MSc; Phone Number: +20 102 237 3920; Email: hematalal93@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31511
      • Recruiting
      • Tanta University Hospitals
      • Contact: Ibrahim T Elshamy; Phone Number: +201022373920; Email: hematalal93@gmail.com
      • Principal Investigator: Mohammed H Hamad, Prof
      • Principal Investigator: Mohammed H Askar, Prof
    • Tanta, El-Gharbia, Egypt, 31511
      • Recruiting
      • Tanta University
      • Contact: Ibrahim T Elshamy; Phone Number: +201022373920; Email: hematalal93@gmail.com
      • Principal Investigator: Mohammed H Hamad, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group one; Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III).	Procedure: Endoscopic frontal sinus surgery grade 6(Draf III).; Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).
Active Comparator: Group two; Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).	Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa); Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of polyp using endoscopic polyp score	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	One year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lund MacKay score	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).	One year postoperatively
Sinonasal Outcome Test- 22	SNOT- 22 was measured based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems	One year postoperatively

Collaborators and Investigators

• Sponsor: Ibrahim Talal Elshamy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: July 29, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Nasal Polyps; Polyps
• Other Study ID Numbers: 34417/1/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: after the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding autho
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No