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Role of Imaging in Complications of Sinusitis

Primary Purpose

Rhinosinusitis, Intracranial Extension, Rhinosinusitis Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Multislice CT scan of the paranasal sinuses.
MRI examination of the paranasal sinuses
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rhinosinusitis focused on measuring Rhinosinusitis, complicated sinusitis, complications of sinusitis, Magnetic resonance imaging, Computed tompgraphy, MRI, CT

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients diagnosed as sinusitis with clinically suspected complications through history and physical examination (site, onset, character of pain, constitutional symptoms, duration). Exclusion Criteria: Patients with absolute or relative contraindications for cross sectional imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.

Sites / Locations

  • Sohag University hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

Outcomes

Primary Outcome Measures

Number of different Types of possible complications detected by CT and MRI
To diagnose the diagnostic accuracy of CT and MRI in detection of different types of orbital and intracranial complications.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2023
Last Updated
April 29, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05836935
Brief Title
Role of Imaging in Complications of Sinusitis
Official Title
Role of Imaging in Complications of Sinusitis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to assess the diagnostic performance of CT and MRI in the diagnosis of complications of rhinosinusitis in comparison to clinical and operative findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinosinusitis, Intracranial Extension, Rhinosinusitis Chronic, Rhinosinusitis Acute, Fungal Sinusitis, Allergic Fungal Rhinosinusitis, Invasive Fungal Sinusitis (Diagnosis)
Keywords
Rhinosinusitis, complicated sinusitis, complications of sinusitis, Magnetic resonance imaging, Computed tompgraphy, MRI, CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Multislice CT scan of the paranasal sinuses.
Intervention Description
MSCT scan using GE Revolution Evo 128 multidetector elements scanner (GE Healthcare, Chicago, Illinois, United state) , Toshiba Alexion 16 detector elements scanner (Aplio 500, Toshiba Medical Systems, Otawara-shi, Tochigi 324-8550, Japan). Or Canon Aquilion Prime SP 160 -multidetector- row CT scanner (Canon Medical Systems, Tochigi, Japan) Thin slice Axial scans will be taken at 0.625-1.0 mm slice thickness, commencing from the hard palate till above the end of frontal sinuses, coronal and sagittal multiplanar reconstruction images will be obtained.
Intervention Type
Radiation
Intervention Name(s)
MRI examination of the paranasal sinuses
Intervention Description
MRI imaging using Philips Achieva 1.5T MRI device (Philips Achieva, Netherlands) or Siemens Magnetom Altea 1.5T MRI device (Siemens Healthineers, Germany) for suspected intracranial and orbital complications.
Primary Outcome Measure Information:
Title
Number of different Types of possible complications detected by CT and MRI
Description
To diagnose the diagnostic accuracy of CT and MRI in detection of different types of orbital and intracranial complications.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients diagnosed as sinusitis with clinically suspected complications through history and physical examination (site, onset, character of pain, constitutional symptoms, duration). Exclusion Criteria: Patients with absolute or relative contraindications for cross sectional imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed O Khalil, resident
Phone
+201001272453
Email
mohamedkhalil@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Th Solyman, Professor
Facility Information:
Facility Name
Sohag University hospitals
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27456592
Citation
Carr TF. Complications of sinusitis. Am J Rhinol Allergy. 2016 Jul;30(4):241-5. doi: 10.2500/ajra.2016.30.4322.
Results Reference
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PubMed Identifier
26307941
Citation
Marchiano E, Raikundalia MD, Carniol ET, Echanique KA, Kalyoussef E, Baredes S, Eloy JA. Characteristics of patients treated for orbital cellulitis: An analysis of inpatient data. Laryngoscope. 2016 Mar;126(3):554-9. doi: 10.1002/lary.25529. Epub 2015 Aug 26.
Results Reference
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PubMed Identifier
22764607
Citation
Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012 Mar;23:3 p preceding table of contents, 1-298.
Results Reference
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PubMed Identifier
21939544
Citation
Chen CY, Sheng WH, Cheng A, Chen YC, Tsay W, Tang JL, Huang SY, Chang SC, Tien HF. Invasive fungal sinusitis in patients with hematological malignancy: 15 years experience in a single university hospital in Taiwan. BMC Infect Dis. 2011 Sep 22;11:250. doi: 10.1186/1471-2334-11-250.
Results Reference
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PubMed Identifier
19544383
Citation
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.
Results Reference
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Role of Imaging in Complications of Sinusitis

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