- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880890
Sphenoid Nasalization in Allergic Fungal Sphenoidal Sinusitis
(Value of Endoscopic Sphenoid Nasalization in Management of Allergic Fungal Sinusitis Involving Sphenoidal Sinus)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fungal rhinosinusitis classified into invasive and noninvasive subtypes. Phenotypes of noninvasive fungal rhinosinusitis occur in immunocompetent subjects and include: local fungal colonization, fungal ball, and allergic fungal rhinosinusitis. Subtypes of invasive fungal rhinosinusitis include acute invasive fungal rhinosinusitis, chronic invasive fungal rhinosinusitis and granulomatous invasive rhinosinusitis.
The estimated incidence of sphenoid sinusitis is only 2.7% of all nasal sinus infections, also the diagnosis of sphenoid sinus fungal infection is sometimes difficult. Clinical signs are often non specific and nasal endoscopy can be strictly normal.Early diagnosis is therefore difficult and diagnosis is often delayed with headache that may sometimes persists for several years before diagnosis of the disease.
In most cases of sphenoid sinusitis, enlargement of the obstructed sinus ostium is sufficient to provide drainage of retained secretions and reestablish mucociliary clearance.According to Simmen and Jones, a type I sphenoidotomy entails identification of the ostium without further intervention; a type II sphenoidotomy entails enlargement of the ostium upward to the level of the cranial base, and inferiorly to one-half of the sinus height; and a type III sphenoidotomy involves widening the ostium to its most lateral extent.
Eloy et al in 2017 stuited that,In more extensive sphenoid sinus surgery is reserved for cases where in the disease process is extensive or previous surgery has failed. In some cases sphenoid nasalization in which bilateral extended sphenoidotomy is necessary. In this procedure, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway . It also allows access to the lateral recesses of this sinus.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: hoda abdelkader mohamed, master
- Phone Number: +201095974700
- Email: hoda_abdelhader@yahoo.com
Study Contact Backup
- Name: mohammed Azzam Abd ElrazaK, profossor
- Phone Number: +201000005651
- Email: mohammadazzam@aun.edu.eg
Study Locations
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Assiut, Egypt, 71516
- Assiut university hospital
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Contact:
- Hoda Abdelkader, MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any age.
- Any case of allergic fungal sinusitis unilateral or bilateral involving the sphenoid sinus
Exclusion Criteria:
- Acute invasive fungal sinusitis.
- Previous Sinonasal surgery.
- Unfit patient for surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sphenoidotomy (group A)
sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus
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sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus sphenoid nasalization in which bilateral extended sphenoidotomy, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway .
|
Active Comparator: sphenoid nasalization (group B)
sphenoid nasalization in which bilateral extended sphenoidotomy, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway .
|
sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus sphenoid nasalization in which bilateral extended sphenoidotomy, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of recurrence
Time Frame: 6 month
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To assess the effect of nasalization of sphenoid sinus on recurrence rate of allergic fungal sinusitis Recurrence will be evaluated by clinical endoscopic evaluationof regular endoscopic examination first visit after one week,the second after 3 weeks and after 3month.
CT nose and paranasal sinus will be done after 3 and 6 months.
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6 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type of caustive organism
Time Frame: 2weeks
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microbiological evaluation of the fungal mud will taken for culture to determine the type of the causative organism and determine if the fungal sinusitis is of invasive or non invasive type
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2weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chakrabarti A, Denning DW, Ferguson BJ, Ponikau J, Buzina W, Kita H, Marple B, Panda N, Vlaminck S, Kauffmann-Lacroix C, Das A, Singh P, Taj-Aldeen SJ, Kantarcioglu AS, Handa KK, Gupta A, Thungabathra M, Shivaprakash MR, Bal A, Fothergill A, Radotra BD. Fungal rhinosinusitis: a categorization and definitional schema addressing current controversies. Laryngoscope. 2009 Sep;119(9):1809-18. doi: 10.1002/lary.20520.
- Rodrigues J, Caruthers C, Azmeh R, Dykewicz MS, Slavin RG, Knutsen AP. The spectrum of allergic fungal diseases of the upper and lower airways. Expert Rev Clin Immunol. 2016;12(5):531-50. doi: 10.1586/1744666X.2016.1142874. Epub 2016 Feb 19.
- Lee TJ, Huang SF, Chang PH. Characteristics of isolated sphenoid sinus aspergilloma: report of twelve cases and literature review. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):211-7. doi: 10.1177/000348940911800309.
- Kwon MO, Kim KS. Headache induced by isolated sphenoid fungal sinusitis: sinus headache? J Headache Pain. 2009 Dec;10(6):473-6. doi: 10.1007/s10194-009-0153-z. Epub 2009 Sep 10.
- Kieff DA, Busaba N. Treatment of isolated sphenoid sinus inflammatory disease by endoscopic sphenoidotomy without ethmoidectomy. Laryngoscope. 2002 Dec;112(12):2186-8. doi: 10.1097/00005537-200212000-00011.
- Eloy JA, Marchiano E, Vazquez A. Extended Endoscopic and Open Sinus Surgery for Refractory Chronic Rhinosinusitis. Otolaryngol Clin North Am. 2017 Feb;50(1):165-182. doi: 10.1016/j.otc.2016.08.013.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- fungal sphenoidal sinusitis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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