Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07368361
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
Detailed 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.
Study:
NCT07368361
Study Brief:
Protocol Section:
NCT07368361