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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство endoscopic nasal operation
  . conventional FESS operation "
• Устройство Reboot operation" Complete removal of inflamed mucosa to periosteum"
  Reboot operation" Complete removal of inflamed mucosa to periosteum"

Первичные конечные точки

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

Критерии участия

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Kafrelsheikh Faculty of Medicine — Egypt

Публикации

• 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, M PMID 32077450
• 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

Идентификаторы

NCT: NCT07368361 · KFSIRB200-710

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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