Recruiting

Reboot Surgery vs. FESS

Sponsor:

Kafrelsheikh University

Code:

NCT07368361

Conditions

CRSWNP

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

endoscopic nasal operation

Reboot operation" Complete removal of inflamed mucosa to periosteum"

Study Details

Brief 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

Conditions

CRSWNP

Study ID

NCT07368361

Start date

Jan 1, 2026

Status verified date

Dec, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: "Comparative Outcomes of Mucosal Reset (Reboot) IN CRSWNP

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

experimental: Complete Sinusotomy (Full House FESS IN CRSWNP

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

Interventions

endoscopic nasal operation

. conventional FESS operation "

Reboot operation" Complete removal of inflamed mucosa to periosteum"

Reboot operation" Complete removal of inflamed mucosa to periosteum"

Primary outcome measure

  • "Comparative Outcomes of Mucosal Reset (Reboot) Versus Complete Sinusotomy (Full House FESS) in CRSwNP: A Prospective Study [ Time Frame: 1-1-2027 ]

Central Contacts and Locations

Central contacts

Amr Maher Shady Kafr Elsheikh Hospital University, Doctor

0201060485163amrshady00@gmail.com

Saad Elzayat Kafr Elsheikh Hospital University, professor

saad_hilmy@med.kfs.edu.eg

Locations

Kafrelsheikh Faculty of Medicine

Recruiting

Egypt, Kafrelsheikh, Canada, 33155.

Contacts

0473109517

More Information

Sponsor

Kafrelsheikh University

Last update posted

May 28, 2026

Last verified

Dec, 2025

Keywords

  • REBOOT, SINUSOTOMY, FULL HOUSE FESS, CRSWNP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kafrelsheikh University on 2026-05-28.