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

Kafrelsheikh University

Status: Enrolling

Conditions: CRSWNP

Treatments: Device: endoscopic nasal operation; Device: Reboot operation" Complete removal of inflamed mucosa to periosteum"

Study type: Interventional

Funder types: Other

Identifiers

NCT07368361

KFSIRB200-710

Details and patient eligibility

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

Full description

Chronic Rhinosinusitis (CRS) affects 5-15% of people globallymmmmm. Traditionally classified as with polyps (CRSwNP) or without (CRSsNP), modern approaches now focus on endotype-based categorization.CRSwNP, linked to type-2 inflammation[4], often causes severe, recurrent symptoms that significantly impair quality of life and increase healthcare costs.[5] Despite this, its impact is frequently underestimated, leading to improper treatment-such as overuse of oral steroids-which risks long-term side effects.

Effective control often requires multimodal therapy, yet results remain inconsistent. Recently, monoclonal antibodies (mAbs) targeting type-2 inflammation have revolutionized treatment, offering long-term relief and addressing comorbidities.

Despite these advances, surgery-particularly endoscopic sinus surgery (ESS)-remains pivotal, especially as initial therapy. ESS continues to evolve, balancing effectiveness, invasiveness, and cost.

For refractory CRSwNP with rapid post-surgery recurrence, repeated interventions are often needed. Recent strategies like the "reboot approach"-complete removal of inflamed sinus mucosa down to the bone-aim to reset the inflammatory environment and promote healthier mucosal regeneration (Alsharif et al.) .

The aim here is to demonstrate how effectiveness of "Reboot surgery: for chronic sinusitis with polyps reduces recurrences, extends symptom-free periods, improves quality of life, and decreases steroid use. We analyze its benefits and limitations based on type 2 inflammation mechanisms.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Patients above the age of 18 years presenting with recurrent refractory CRSwNP (failed ≥1 biologic/prior FESS), Type-2 endotype confirmation (blood/tissue eosinophilia, IgE ≥100 IU/mL), Lund-Mackay CT score ≥10 will be included in the study.

Exclusion Criteria:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

"Comparative Outcomes of Mucosal Reset (Reboot) IN CRSWNP

Experimental group

Description:

The first group will undergo Reboot operation" Complete removal of inflamed mucosa to periosteum"

Treatment:

Device: Reboot operation" Complete removal of inflamed mucosa to periosteum"

Complete Sinusotomy (Full House FESS IN CRSWNP

Experimental group

Description:

the second group will have a conventional FESS operation " Mucosal preservation where healthy"

Treatment:

Device: endoscopic nasal operation