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Sphenoid Nasalization in Allergic Fungal Sphenoidal Sinusitis

Primary Purpose

Fungal Sinusitis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sphenoidotomy versus sphenoid nasalisation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Sinusitis focused on measuring sphenoid nasalization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sphenoidotomy (group A)

sphenoid nasalization (group B)

Arm Description

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 .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2019
Last Updated
March 17, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03880890
Brief Title
Sphenoid Nasalization in Allergic Fungal Sphenoidal Sinusitis
Official Title
(Value of Endoscopic Sphenoid Nasalization in Management of Allergic Fungal Sinusitis Involving Sphenoidal Sinus)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Sinusitis
Keywords
sphenoid nasalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group (A): sphenoidotomy. Group (B): Endoscopic sphenoid nasalization with posterior septectomy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sphenoidotomy (group A)
Arm Type
Active Comparator
Arm Description
sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus
Arm Title
sphenoid nasalization (group B)
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Procedure
Intervention Name(s)
sphenoidotomy versus sphenoid nasalisation
Intervention Description
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 .
Primary Outcome Measure Information:
Title
rate of recurrence
Description
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.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Type of caustive organism
Description
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
Time Frame
2weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hoda abdelkader mohamed, master
Phone
+201095974700
Email
hoda_abdelhader@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed Azzam Abd ElrazaK, profossor
Phone
+201000005651
Email
mohammadazzam@aun.edu.eg
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71516
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoda Abdelkader, MSc

12. IPD Sharing Statement

Citations:
PubMed Identifier
19544383
Citation
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.
Results Reference
result
PubMed Identifier
26776889
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.
Results Reference
result
PubMed Identifier
19374153
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. doi: 10.1177/000348940911800309.
Results Reference
result
PubMed Identifier
19763769
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.
Results Reference
result
PubMed Identifier
12461338
Citation
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.
Results Reference
result
PubMed Identifier
27888912
Citation
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.
Results Reference
result

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Sphenoid Nasalization in Allergic Fungal Sphenoidal Sinusitis

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