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

ConditionCRSWNP

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorKafrelsheikh University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: "Comparative Outcomes of Mucosal Reset (Reboot) IN CRSWNPExperimental treatment 1 intervention

Group B: Complete Sinusotomy (Full House FESS IN CRSWNPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

"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)

Time frame

1-1-2027

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov

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