RecruitingNot ApplicableNCT07368361

Th Study Wants to Compare the Best Technique for Sinus Operation in CRSWNP

"Comparative Outcomes of Mucosal Reset (Reboot) Versus Complete Sinusotomy (Full House FESS) in CRSwNP: A Prospective Study


Sponsor

Kafrelsheikh University

Enrollment

40 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Exclusion Criteria1

  • eosinophilic granulomatosis with polyangiitis (EGPA) or severe systemic diseases (except controlled asthma or NSAID-exacerbated respiratory disease), neoplasms, vasoconstrictor abuse (e.g., oxymetazoline dependence), unilateral nasal inflammatory disease, bilateral inflammatory disease without polyps, or treatment with monoclonal antibodies in the past 12 months, Patients younger than 18 years of age and patients are unfit for general anesthesia.

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Interventions

DEVICEendoscopic nasal operation

. conventional FESS operation "

DEVICEReboot operation" Complete removal of inflamed mucosa to periosteum"

Reboot operation" Complete removal of inflamed mucosa to periosteum"


Locations(1)

Kafrelsheikh Faculty of Medicine

Egypt, Kafrelsheikh, Canada

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NCT07368361