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

NCT07368361 | Recruiting DMC

• 1 other identifier: KFSIRB200-710
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

REBOOT, SINUSOTOMY, FULL HOUSE FESS, CRSWNP

Outcome Measures

Primary Outcomes (1)

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

  24-month recurrence rates (defined as endoscopic polyp score ≥2)

  1-1-2027

Study Arms (2)

"Comparative Outcomes of Mucosal Reset (Reboot) IN CRSWNP

EXPERIMENTAL

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

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

Complete Sinusotomy (Full House FESS IN CRSWNP

EXPERIMENTAL

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

Device: endoscopic nasal operation

Interventions

endoscopic nasal operation DEVICE

. conventional FESS operation "

Complete Sinusotomy (Full House FESS IN CRSWNP

Reboot operation" Complete removal of inflamed mucosa to periosteum" DEVICE

Reboot operation" Complete removal of inflamed mucosa to periosteum"

"Comparative Outcomes of Mucosal Reset (Reboot) IN CRSWNP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh Faculty of Medicine

Egypt, Kafrelsheikh, 33155., Canada

RECRUITING

Related Publications (2)

• Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.

  PMID: 32077450 RESULT

• Alsharif S, Jonstam K, van Zele T, Gevaert P, Holtappels G, Bachert C. Endoscopic Sinus Surgery for Type-2 CRS wNP: An Endotype-Based Retrospective Study. Laryngoscope. 2019 Jun;129(6):1286-1292. doi: 10.1002/lary.27815. Epub 2019 Jan 21.

  PMID: 30663058 RESULT

Central Study Contacts

Amr Maher Shady Kafr Elsheikh Hospital University, Doctor

CONTACT

0201060485163; amrshady00@gmail.com

Saad Elzayat Kafr Elsheikh Hospital University, professor

CONTACT

saad_hilmy@med.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Model Details: This randomized controlled trial aims to compare the efficacy and safety of reboot surgery versus conventional full house FESS in patients with refractory CRSwNP

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 28, 2026

Record last verified: 2025-12

Locations

CA (1)