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Efficacy of Intranasal corticosteroid spray versus placebo in post-operative endoscopic sinus surgery of patient with sinus fungal ball

Phase 3
Conditions
The role of INCS in post operative sinus surgery in patient with sinus fungal ball.
Sinus fungal ball, Intranasal corticosteroid, Post operative endoscopic sinus surgery
Registration Number
TCTR20230310001
Lead Sponsor
Otolaryngology department, Ramathibodi hospital, Mahidol university
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
65
Inclusion Criteria

1. Age equal or more than 18 years old
2. Imaging and intra-operative sinuses finding associated with sinus fungal ball
3. Patient consent to join the research project

Exclusion Criteria

1. Pathology show invasive fungal sinusitis
2. Previous sinus surgery
3. Previous radiation therapy at head and neck
4. Having underlying diseases such as Ciliary dyskinesia, Cystic fibrosis
5. Taking immunosuppressive drugs
6. Patient with allergic rhinitis who need to regularly use intranasal corticosteroid
7. Patient who taking these drug before surgery
7.1. Oral or IV corticosteroid 4 weeks
7.2. Topical corticosteroid 2 weeks
7.3. Intramuscular corticosteroid 4 week
8. Patient who have fluticasone furoate drug allergy
9. Pregnancy
10. Breast feeding
11. Patient deny to consent the research project

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Endoscopic score 3 months Lund Kennedy endoscopic score
Secondary Outcome Measures
NameTimeMethod
chronic rhinosinusitis health-related quality-of-life outcome (HRQoL) measure 3 months SNOT-22,self questionnaire for evaluate severity of sinus symptoms 3 months VAS score
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