- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07702188
Different Endoscopic Approaches for Sphenoid Sinus
Different Approaches for Sphenoid Sinus
- Identification of the most effective approach for different lesion types
- Correlation between approach and complication rates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The sphenoid sinus is one of the most anatomically complex and surgically challenging paranasal sinuses due to its deep location ,wide anatomical variation and proximity to critical neurovascular structures.
Important structures are adjacent to the sphenoid sinus include the dura, pituitary, optic nerve, cavernous sinus, pterygoid canal and nerve, internal carotid artery, and cranial nerves III, IV, VI, V1, V2, which are vulnerable to injury with sphenoid disease.
Wide anatomical variation such as Degree of Pneumatization , Septation Patterns , Sinus Size and Shape, Ostium Location ,Onodi Cells, Prominence or dehiscence of nearby structures.
Therefore, surgeons must carefully select the extent of dissection to create a sphenoid opening that matches the patient's pathology while avoiding the risks associated with overly extensive openings and drilling, which may prolong healing and increase the likelihood of scarring and stenosis.
Diagnostic nasal endoscopy procedures and imaging techniques are of great value for an early and precise diagnosis.
Moreover, endoscopic sinus surgery is a safe and effective technique that allows a direct route to the sphenoid sinus.
Because of its close vicinity to important and vulnerable structures of the skull base, delay in diagnosis and treatment can be potentially lethal.
Sphenoid sinus lesions may range from mild, isolated inflammation to erosive tumors with cranial nerve deficits or cases requiring access to a pneumatized lateral recess .
Additionally, conditions such as tumors, encephaloceles, mucoceles, and skull base lesions demand extra preoperative planning and careful technique selection.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doaa Araby Mohamed, assistant lecturer
- Phone Number: +201119015094
- Email: DoaaAraby9@aun.edu.eg
Study Contact Backup
- Name: Ahmed elrahman mohamed azzam, lecturer
- Phone Number: 01099978990
- Email: ahmedazzam@aun.edu.eg
Study Locations
-
-
-
Asyut, Egypt
- Assiut University Hospital
-
Contact:
- Doaa Mohamed
- Phone Number: 01119015094
- Email: DoaaAraby9@aun.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with sinonasal lesions involving sphenid sinus with or without skull base extension.
Exclusion Criteria
- Severe comorbidities contraindicating surgery
- malignant tumer extend beyond sphenoid sinus requiring open management
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: endoscopic approaches for sphenoid sinus
type I, sphenoid ostial dilation.
type IIa, transnasal sphenoidotomy (sphenoidotomy without ethmoidectomy).
type IIb, transethmoidal sphenoidotomy (sphenoidotomy with ethmoidectomy).
type III, bilateral, common cavity sphenoidotomy, or "sphenoid drill-out;" type IV, transpterygoid approach, to expose the lateral sphenoid sinus recess.
type V, sphenoid nasalization, completely removing the sphenoid sinus floor.
|
Different approaches include: type I, sphenoid ostial dilation. type IIa, transnasal sphenoidotomy (sphenoidotomy without ethmoidectomy). type IIb, transethmoidal sphenoidotomy (sphenoidotomy with ethmoidectomy). type III, bilateral, common cavity sphenoidotomy, or "sphenoid drill-out;" type IV, transpterygoid approach, to expose the lateral sphenoid sinus recess. type V, sphenoid nasalization, completely removing the sphenoid sinus floor. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate different endoscopic surgical approaches to the sphenoid sinus
Time Frame: 6 months
|
|
6 months
|
|
To evaluate different endoscopic surgical approaches to the sphenoid sinus regarding: * Completence of lesion removal. * Complications. - Csf leakage - Optic nerve injury
Time Frame: 6 month
|
complications rate (csf leakage , optic nerve injury, carotid artery injury)
|
6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: mohamed modather, assistant professor, Assiut University
Publications and helpful links
General Publications
- https://scholar.google.com/?hl=ar
Helpful Links
- Castelnuovo, P., Pagella, F., Semino, L., De Bernardi, F., & Delù, G. (2005). Endoscopic treatment of the isolated sphenoid sinus lesions. European Archives of Oto-Rhino-Laryngology and Head & Neck, 262(2), 142-147.
- 3-Jang, J. Y., Kim, G. J., Kim, S. Y., Kim, M. S., Lee, D. K., Kwon, M., ... & Cho, K. J. (2025). Guidelines for the treatment of laryngeal cancer from the Korean society of head and neck surgery. Clinical and experimental otorhinolaryngology, 18(2), 89-
- -Lawson, W., & Reino, A. J. (1997). Isolated sphenoid sinus disease: an analysis of 132 cases. The Laryngoscope, 107(12), 1590-1595..
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- sphenoid sinus approaches
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endoscopic Sinus Surgery
-
EgymedicalpediaNot yet recruiting
-
Kafrelsheikh UniversityCompletedEndoscopic Sinus SurgeryEgypt
-
University of ThessalyNot yet recruiting
-
Spirair, IncActive, not recruitingSinus Endoscopic Surgery | TurbinateUnited States
-
Kafrelsheikh UniversityRecruitingDexmedetomidine | Functional Endoscopic Sinus SurgeryEgypt
-
Cairo UniversityNot yet recruitingFunctional Endoscopic Sinus Surgery (FESS)Egypt
-
Richard CartabukeCompletedAdenoidectomy | Turbinate Surgery | Functional Endoscopic Sinus Surgery (FESS)United States
-
Al-Azhar UniversityCompletedAnalgesia | Functional Endoscopic Sinus Surgery | PremedicationEgypt
-
Tanta UniversityCompletedDexmedetomidine | Functional Endoscopic Sinus Surgery | AminophyllineEgypt
-
Al-Azhar UniversityCompletedEndoscopic Sinus Surgery | Navigation | Computer Assisted | Sinonasal PolyposisEgypt
Clinical Trials on endoscopic sinus surgery
-
Helsinki University Central HospitalCompletedAsthma | Nasal Polyps | Aspirin Sensitivity | Sinusitis, ChronicFinland, Netherlands
-
State University of New York - Upstate Medical...TerminatedChronic Sinusitis | Adenoid Disease - ChronicUnited States
-
Oregon Health and Science UniversityMedical University of South CarolinaActive, not recruitingChronic Rhinosinusitis | Olfactory Dysfunction
-
Beijing Tongren HospitalCompletedChronic Rhinosinusitis (Diagnosis) | Surgery
-
Al-Azhar UniversityCompletedEndoscopic Sinus Surgery | Navigation | Computer Assisted | Sinonasal PolyposisEgypt
-
Zheng LiuWuhan Central Hospital; Wuhan No.1 Hospital; Wuhan Third Hospital; Tianyou Hospital... and other collaboratorsCompletedChronic Sinusitis | Nasal Polyps | Endoscopic Sinus SurgeryChina
-
Instituto Nacional de Enfermedades RespiratoriasUnknownSleep | Aspirin-exacerbated Respiratory DiseaseMexico
-
University of California, San FranciscoCompletedAsthma | Chronic RhinosinusitisUnited States
-
Entellus Medical, Inc.CompletedChronic SinusitisUnited States
-
IWitterickWithdrawnRhinosinusitis | Disorder of Maxillary Sinus | Aspirin-sensitive Asthma With Nasal PolypsCanada