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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979662
• Other study ID #: 34417/1/21
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: Tanta University
• Contact: Ibrahim T Elshamy, MSc
• Phone: +20 102 237 3920
• Email: hematalal93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Procedure:
• Endoscopic frontal sinus surgery grade 6(Draf III).
Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).
• 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).

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia
Egypt	Tanta University Hospitals	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Ibrahim Talal Elshamy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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