Role of Imaging in Complications of Sinusitis

Rhinosinusitis Clinical Trial

Official title:

Role of Imaging in Complications of Sinusitis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05836935
• Other study ID #: Soh-Med-23-04-02MS
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Sohag University
• Contact: Mohammed O Khalil, resident
• Phone: +201001272453
• Email: mohamedkhalil[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Fungal Rhinosinusitis
• Fungal Sinusitis
• Rhinosinusitis
• Rhinosinusitis Acute
• Rhinosinusitis Chronic
• Sinusitis

Intervention

Radiation:
• Multislice CT scan of the paranasal sinuses.
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.
• MRI examination of the paranasal sinuses
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.

Locations

Country	Name	City	State
Egypt	Sohag University hospitals	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Carr TF. Complications of sinusitis. Am J Rhinol Allergy. 2016 Jul;30(4):241-5. doi: 10.2500/ajra.2016.30.4322. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months