A Multislice Computed Tomographic Study of the Sphenoid S... | NCT03222934

Studies
A Multislice Computed Tomographic Study of the Sphenoid Sinus

NCT03222934

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 19, 2017Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Nasal Disorder

Interventions

multislice computed tomography

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Apr 1, 2018Estimated

Completion Date

Sep 1, 2018Estimated

First Submitted Date

Jul 17, 2017

First Submission Date that Met QC Criteria

Jul 17, 2017

First Posted Date

Jul 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2017

Last Update Posted Date

Jul 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

•Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures .Detailed, meticulous preoperative radiological study of sphenoid sinus is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons

Detailed Description

Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures such as the optic nerve, optic chiasm, cavernous sinus, pituitary gland, and internal carotid artery. Detailed, meticulous preoperative radiological study of sphenoid sinus variations as in Onodi cells (Sphenoethmoidal air cell) is an anatomical variant of the paranasal sinuses, important due to its close proximity to the optic nerve and internal carotid artery. , Pnumatization pattern as the extent of pneumatization is highly variable and potentially jeopardizing to surrounding vital structures , Septation pattern , Intercarotid distance (in millimeters), Bony covering of carotid artery, Bony covering of optic nerve.is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nasal disorders		patients with nasal disorders with free sphenoid sinus	Device: multislice computed tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multislice computed tomography	Device	radiological diagnosis of the status and variations in the sphenoid sinus	Nasal disorders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of anatomical variations of the sphenoid sinus		30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with free sphenoid sinus

Exclusion Criteria:

pathology in the sphenoid sinus
refusal of patients for inclusion in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with nasal disorders with free sphenoid sinus

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Akram Shahat, MBBCh	Contact	00201092626189		akramshahat91@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University		Asyut			Egypt	Akram Shahat, MBBCh

Condition Browse Module

MeSH Terms

ID	Term
D009668	Nose Diseases

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061330	Multidetector Computed Tomography

Ancestor Terms

ID	Term
D036542	Tomography, Spiral Computed
D014057	Tomography, X-Ray Computed
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided