NCT03222934

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

July 17, 2017

Last Update Submit

July 17, 2017

Conditions

Nasal Disorder

Outcome Measures

Primary Outcomes (1)

  • The rate of anatomical variations of the sphenoid sinus

    30 minutes

Study Arms (1)

Nasal disorders

patients with nasal disorders with free sphenoid sinus

Device: multislice computed tomography

Interventions

multislice computed tomographyDEVICE

radiological diagnosis of the status and variations in the sphenoid sinus

Nasal disorders

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with nasal disorders with free sphenoid sinus

You may qualify if:

  • patients with free sphenoid sinus

You may not qualify if:

  • pathology in the sphenoid sinus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Nose Diseases

Interventions

Multidetector Computed Tomography

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Spiral ComputedTomography, X-Ray ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Central Study Contacts

Akram Shahat, MBBCh

CONTACT

00201092626189akramshahat91@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

January 1, 2018

Primary Completion

April 1, 2018

Study Completion

September 1, 2018

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

EG(1)