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Study aim
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The study objectives include determining the effect of omalizumab on nasal polyposis recurrence, nasal-related quality of life, and symptom severity after surgery.
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Design
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A controlled, double-blind, randomized, phase 2-3 clinical trial with parallel groups on 36 patients. The rand function of Excel software will be used for randomization.
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Settings and conduct
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This study will be conducted in the ENT Department of Besat Hospital, Hamadan, on patients with allergic fungal sinusitis who will undergo endoscopic sinus surgery. For blinding, both omalizumab and placebo will be prepared by injection using identical syringes by a nurse who is not involved in the study and is unaware of the type of drug. The physician who will perform the endoscopic evaluations and the person who will perform the statistical analyses will also be unaware of the groups until the end of the analysis (double-blind).
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Participants/Inclusion and exclusion criteria
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Patients with a diagnosis of allergic fungal rhinosinusitis who will undergo endoscopic sinus surgery.
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Intervention groups
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Both groups will receive standard postoperative treatment regimen (including nasal irrigation with saline, mucolytic drugs, and topical corticosteroids). The intervention group will receive subcutaneous omalizumab injection at a dose of 0.016 mg/kg for 2 months in addition to standard treatment.
Control group: Will receive placebo (injectable vitamin B complex) instead of omalizumab.
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Main outcome variables
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The primary outcome of this study is the frequency of nasal polyp recurrence. This outcome will be measured at four time points: one month, two months, three months, and six months after the intervention: The Lund-Kendy score grades the pathological conditions visible on nasal endoscopy, including polyps, discharge, edema, scarring, and scaling, with higher scores indicating greater disease severity.