Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sphenoid Nasalization in Allergic Fungal Sphenoidal Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03880890
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
hoda abdelkader mohamed, Assiut University

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 .

Condition or disease Intervention/treatment Phase
Fungal Sinusitis Procedure: sphenoidotomy versus sphenoid nasalisation Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group (A): sphenoidotomy. Group (B): Endoscopic sphenoid nasalization with posterior septectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: (Value of Endoscopic Sphenoid Nasalization in Management of Allergic Fungal Sinusitis Involving Sphenoidal Sinus)
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds Sinusitis

Arm Intervention/treatment
Active Comparator: sphenoidotomy (group A)
sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus
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 .

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 .
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 .




Primary Outcome Measures :
  1. rate of recurrence [ Time Frame: 6 month ]
    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 :
  1. Type of caustive organism [ Time Frame: 2weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880890


Contacts
Layout table for location contacts
Contact: hoda abdelkader mohamed, master +201095974700 hoda_abdelhader@yahoo.com
Contact: mohammed Azzam Abd ElrazaK, profossor +201000005651 mohammadazzam@aun.edu.eg

Locations
Layout table for location information
Egypt
Assiut University Hospital Not yet recruiting
Assiut, Egypt, 71516
Contact: Hoda Abdelkader, MSc         
Sponsors and Collaborators
Assiut University

Publications of Results:
Layout table for additonal information
Responsible Party: hoda abdelkader mohamed, ENTspechilist, Assiut University
ClinicalTrials.gov Identifier: NCT03880890     History of Changes
Other Study ID Numbers: fungal sphenoidal sinusitis
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hoda abdelkader mohamed, Assiut University:
sphenoid nasalization

Additional relevant MeSH terms:
Layout table for MeSH terms
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases