Sphenoid Nasalization in Allergic Fungal Sphenoidal Sinusitis

Fungal Sinusitis Clinical Trial

Official title:

(Value of Endoscopic Sphenoid Nasalization in Management of Allergic Fungal Sinusitis Involving Sphenoidal Sinus)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03880890
• Other study ID #: fungal sphenoidal sinusitis
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: October 2022

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: hoda abdelkader mohamed, master
• Phone: +201095974700
• Email: hoda_abdelhader[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the outcome of different two endoscopic sphenoid procedure for management of allergic fungal sphenoidal sinusitis : sphenoidotomy versus sphenoid nasalization with posterior septectomy .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fungal Sinusitis
• Sinusitis

Intervention

Procedure:
• sphenoidotomy versus sphenoid nasalisation
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 .

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. F — View Citation

Eloy JA, Marchiano E, Vázquez 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. Review. — View Citation

Kieff DA, Busaba N. Treatment of isolated sphenoid sinus inflammatory disease by endoscopic sphenoidotomy without ethmoidectomy. Laryngoscope. 2002 Dec;112(12):2186-8. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of recurrence	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.	6 month
Secondary	Type of caustive organism	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	2weeks