Actively Recruiting
Th Study Wants to Compare the Best Technique for Sinus Operation in CRSWNP
Led by Kafrelsheikh University · Updated on 2026-01-26
40
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized controlled trial aims to compare the efficacy and safety of reboot surgery versus conventional full house FESS in patients with refractory CRSwNP, focusing on: 1\. Primary Outcome: * Compare 24-month recurrence rates (defined as endoscopic polyp score ≥2) 2. Secondary Outcomes: * Recurrence-free survival (time to first recurrence), Quality of life improvement (SNOT-22 scores), Reduction in systemic corticosteroid use, Complication rates (synechiae, bleeding, infection) and Cost-effectiveness of each approach
CONDITIONS
Official Title
Th Study Wants to Compare the Best Technique for Sinus Operation in CRSWNP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- Recurrent refractory chronic rhinosinusitis with nasal polyps (CRSwNP) not improved after at least one biologic or prior FESS surgery
- Confirmed type-2 inflammation endotype by blood or tissue eosinophilia or IgE 7100 IU/mL
- Lund-Mackay CT score of 10 or higher
You will not qualify if you...
- Eosinophilic granulomatosis with polyangiitis (EGPA) or severe systemic diseases except controlled asthma or NSAID-exacerbated respiratory disease
- Presence of neoplasms
- Dependence on vasoconstrictor drugs such as oxymetazoline
- Unilateral nasal inflammatory disease
- Bilateral inflammatory disease without polyps
- Treatment with monoclonal antibodies in the past 12 months
- Patients younger than 18 years
- Patients unfit for general anesthesia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kafrelsheikh Faculty of Medicine
Egypt, Kafrelsheikh, Canada, 33155.
Actively Recruiting
Research Team
A
Amr Maher Shady Kafr Elsheikh Hospital University, Doctor
CONTACT
S
Saad Elzayat Kafr Elsheikh Hospital University, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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