Comparing reboot surgery and conventional full-house FESS for adults with recurrent nasal polyps (CRSwNP)
"Comparative Outcomes of Mucosal Reset (Reboot) Versus Complete Sinusotomy (Full House FESS) in CRSwNP: A Prospective Study
NA · Kafrelsheikh University · NCT07368361
This trial will test whether reboot surgery or conventional full-house FESS better prevents polyp return and improves symptoms for adults with refractory CRSwNP.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University (other) |
| Locations | 1 site (Egypt, Kafrelsheikh) |
| Trial ID | NCT07368361 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll adults with refractory CRSwNP and randomly assign them to either reboot surgery (complete removal of inflamed mucosa to the periosteum) or conventional full-house endoscopic sinus surgery (FESS). The primary outcome is polyp recurrence at 24 months, defined by an endoscopic polyp score of ≥2. Secondary outcomes include recurrence-free survival, changes in SNOT-22 quality-of-life scores, systemic corticosteroid use, complication rates, and cost-effectiveness. All surgeries and follow-up visits are conducted at Kafrelsheikh Faculty of Medicine with standardized surgical and follow-up protocols.
Who should consider this trial
Good fit: Adults (≥18 years) with refractory CRSwNP who have failed at least one prior FESS or biologic, have evidence of type-2 inflammation (blood/tissue eosinophilia or IgE ≥100 IU/mL), and a Lund–Mackay CT score ≥10 are ideal candidates.
Not a fit: Patients with non–type-2 disease, unilateral nasal inflammatory conditions, recent treatment with monoclonal antibodies (within 12 months), eosinophilic granulomatosis with polyangiitis (EGPA), severe uncontrolled systemic disease, or who are unfit for general anesthesia are unlikely to benefit from or be eligible for this approach.
Why it matters
Potential benefit: If successful, reboot surgery could reduce polyp recurrence, extend symptom-free periods, lower steroid requirements, and improve quality of life compared with conventional FESS.
How similar studies have performed: Smaller case series and retrospective reports have suggested reboot surgery can lower recurrence rates compared with standard ESS, but high-quality randomized data are limited.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Egypt, Kafrelsheikh
- Kafrelsheikh Faculty of Medicine — Egypt, Kafrelsheikh, Canada (RECRUITING)
Study contacts
- Study coordinator: Amr Maher Shady Kafr Elsheikh Hospital University, Doctor
- Email: amrshady00@gmail.com
- Phone: 0201060485163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: CRSWNP, REBOOT, SINUSOTOMY, FULL HOUSE FESS, CRSWNP