- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Doaa Araby Mohamed, assistant lecturer
- Telefonnummer: +201119015094
- E-post: DoaaAraby9@aun.edu.eg
Studera Kontakt Backup
- Namn: Ahmed elrahman mohamed azzam, lecturer
- Telefonnummer: 01099978990
- E-post: ahmedazzam@aun.edu.eg
Studieorter
-
-
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Asyut, Egypten
- Assiut University hospital
-
Kontakt:
- Doaa Mohamed
- Telefonnummer: 01119015094
- E-post: DoaaAraby9@aun.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To evaluate different endoscopic surgical approaches to the sphenoid sinus
Tidsram: 6 months
|
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6 months
|
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To evaluate different endoscopic surgical approaches to the sphenoid sinus regarding: * Completence of lesion removal. * Complications. - Csf leakage - Optic nerve injury
Tidsram: 6 month
|
complications rate (csf leakage , optic nerve injury, carotid artery injury)
|
6 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: mohamed modather, assistant professor, Assiut University
Publikationer och användbara länkar
Allmänna publikationer
- https://scholar.google.com/?hl=ar
Användbara länkar
- 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..
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- sphenoid sinus approaches
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