Fungal SinusitisNCT03880890
Sphenoid Nasalization in Allergic Fungal Sphenoidal Sinusitis
A study testing sphenoidotomy versus sphenoid nasalisation in people with Fungal Sinusitis, run by Assiut University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fungal Sinusitis
- What is being tested?
- sphenoidotomy versus sphenoid nasalisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2019to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any age.
- Any case of allergic fungal sinusitis unilateral or bilateral involving the sphenoid sinus
Who cannot join
- Acute invasive fungal sinusitis.
- Previous Sinonasal surgery.
- Unfit patient for surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (Value of Endoscopic Sphenoid Nasalization in Management of Allergic Fungal Sinusitis Involving Sphenoidal Sinus)
To study the outcome of different two endoscopic sphenoid procedure for management of allergic fungal sphenoidal sinusitis : sphenoidotomy versus sphenoid nasalization with posterior septectomy .
Read the 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.
- Conditions
- Fungal Sinusitis
- Being tested
- sphenoidotomy versus sphenoid nasalisation
- Keywords
- sphenoid nasalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sphenoidotomy versus sphenoid nasalisationProcedure or surgery
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 .
| Study group | Role | What they receive |
|---|---|---|
| sphenoidotomy (group A) | Active comparator | sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus Receives: Procedure: sphenoidotomy versus sphenoid nasalisation |
| sphenoid nasalization (group B) | Active comparator | 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 . Receives: Procedure: sphenoidotomy versus sphenoid nasalisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (1)
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
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fungal SinusitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group (A): sphenoidotomy. Group (B): Endoscopic sphenoid nasalization with posterior septectomy
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hoda abdelkader mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880890
- Sponsor's protocol ID
- fungal sphenoidal sinusitis
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 19544383Rodrigues 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.
PubMed 26776889Lee 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.
PubMed 19374153Kwon 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.
PubMed 19763769Kieff 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.
PubMed 12461338Eloy 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.
PubMed 27888912
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Value of Endoscopic Sphenoid Nasalization in Management of Allergic Fungal Sinusitis Involving Sphenoidal Sinus)
- ClinicalTrials.gov ID
- NCT03880890
- Acronym / sponsor ID
- fungal sphenoidal sinusitis
- Conditions
- Fungal Sinusitis
- Keywords
- sphenoid nasalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group (A): sphenoidotomy. Group (B): Endoscopic sphenoid nasalization with posterior septectomy
| Arm | Type | Receives |
|---|---|---|
| sphenoidotomy (group A) | Active comparator | Procedure: sphenoidotomy versus sphenoid nasalisationsphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus |
| sphenoid nasalization (group B) | Active comparator | Procedure: sphenoidotomy versus sphenoid nasalisationsphenoid 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 . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any age.
- Any case of allergic fungal sinusitis unilateral or bilateral involving the sphenoid sinus
Key exclusion criteria (3 listed)
- Acute invasive fungal sinusitis.
- Previous Sinonasal surgery.
- Unfit patient for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sphenoidotomy versus sphenoid nasalisationsphenoidotomy 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 . | Procedure or surgery | sphenoid nasalization (group B), sphenoidotomy (group A) |
Primary outcome
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.
1 secondary outcome
Type of caustive organism
Time frame: 2weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 19544383Chakrabarti 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 publication: PubMed 26776889Rodrigues 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 publication: PubMed 19374153Lee 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 publication: PubMed 19763769Kwon 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 publication: PubMed 12461338Kieff 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 publication: PubMed 27888912Eloy 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.
Related trials for Fungal Sinusitis
Recruiting
Diagnostics of Mycotic Sinusitis in ENT Patients
Fungal Sinusitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sphenoidotomy versus sphenoid nasalisation in people with Fungal Sinusitis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hoda abdelkader mohamed, master (+201095974700, hoda_abdelhader@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of recurrence (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880890, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.