Back to resultsEndoscopic Frontal Sinus Surgery Draf III in Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
Primary Purpose
Endoscopic Frontal Sinus Surgery, Chronic Rhinosinusitis With Nasal Polyps, Draf III
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic frontal sinus surgery grade 6(Draf III).
Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)
Sponsored by
About this trial
This is an interventional treatment trial for Endoscopic Frontal Sinus Surgery
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
Sites / Locations
- Tanta University HospitalsRecruiting
- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group one
Group two
Arm Description
Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III).
Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979662
Brief Title
Endoscopic Frontal Sinus Surgery Draf III in Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
Official Title
Clinical Evaluation of Primary Endoscopic Frontal Sinus Surgery Grade 6 (Draf III) in Patients With Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ibrahim Talal Elshamy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Frontal Sinus Surgery, Chronic Rhinosinusitis With Nasal Polyps, Draf III, Draf I or IIa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group one
Arm Type
Experimental
Arm Description
Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III).
Arm Title
Group two
Arm Type
Active Comparator
Arm Description
Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).
Intervention Type
Procedure
Intervention Name(s)
Endoscopic frontal sinus surgery grade 6(Draf III).
Intervention Description
Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).
Intervention Type
Procedure
Intervention Name(s)
Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)
Intervention Description
Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).
Primary Outcome Measure Information:
Title
Recurrence of polyp using endoscopic polyp score
Description
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
Time Frame
One year postoperatively
Secondary Outcome Measure Information:
Title
Lund MacKay score
Description
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).
Time Frame
One year postoperatively
Title
Sinonasal Outcome Test- 22
Description
SNOT- 22 was measured based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems
Time Frame
One year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim T Elshamy, MSc
Phone
+20 102 237 3920
Email
hematalal93@gmail.com
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim T Elshamy
Phone
+201022373920
Email
hematalal93@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohammed H Hamad, Prof
First Name & Middle Initial & Last Name & Degree
Mohammed H Askar, Prof
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim T Elshamy
Phone
+201022373920
Email
hematalal93@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohammed H Hamad, Prof
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Endoscopic Frontal Sinus Surgery Draf III in Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
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