- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05989919
Nasal Anatomical and Pathological Variants in Patients With Antrochoanal Polyps
The goal of this observational study is to learn about anatomical and pathological variants in patients with antrochoanal polyps trying to find a key to its pathogenesis Participants will have nasal endoscopic examination and CT nose and paranasal sinuses.
we will compare patients with antrochoanal polyps and other patients with unilateral sinonasal disease regarding anatomical and pathological variants.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was conducted at Otolaryngology department, Minia University Hospital, Minia, Egypt. The study was approved by the Institutional Review Board at Minia University.
The study participants were recruited from patients complaining from unilateral sinonasal disease attending outpatient clinic.
we selected 40 patients with ACPs who had the following inclusion criteria: 1-radiologically diagnosed based on CT nose and PNS. 2-histopathologically diagnosed as ACP. The radiological diagnosis is based on seeing low attenuated soft tissue mass filling the maxillary antrum and extending through the middle meatus into the nasal cavity and directs towards the post nasal opening. We excluded: 1- patients with history of maxillofacial trauma. 2- patients who had previous nasal surgery.
To be more objective, a control group of 40 patients who had unilateral sinonasal disease other than ACP was formed.
We assessed multislice computed tomography (CT) nose and paranasal sinus images by Toshiba aquilion CT scanner. Axial and coronal 250mm cuts were obtained.
Both study and control groups were compared regarding anatomical and pathological variations in the nose. These variants include: deviated nasal septum, concha bullosa, paradoxical middle turbinate and uncinate process insertion (to lamina papyrecea or roof of ethmoid or middle turbinate). We also compare between them according to presence of retention cyst in CT in contralateral side In the cases with deviated nasal septum, the septal deviation was seen if it is towards the side of the lesion or towards the opposite side according to its convexity.
We also evaluate the sclerosis on thickening of the bony wall of the para nasal sinus as an indication of chronic inflammation.
SPSS 24.0 program was used for statistical analysis. Averages and standard deviations were calculated. The Mann-Whitney and Chi square tests were used for comparisons between the groups. The Pearson correlation tests was used to evaluate correlations. Statistical significance was set at ≤ 0.05.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Minya, Egypt
- Faculty of medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- radiologically diagnosed based on CT nose and PNS.
- histopathologically diagnosed as ACP.
Exclusion Criteria:
- patients with history of maxillofacial trauma.
- patients who had previous nasal surgery.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
study group
patients with antrochoanal polyps
|
CT scan for nose and paranasal sinuses
|
|
control group
patients with unilateral sinonasal disease other than antrochoanal polyps
|
CT scan for nose and paranasal sinuses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
presence of anatomical and pathological variants in CT scan and endoscopic examination
Time Frame: 6 months
|
Both study and control groups were compared regarding anatomical and pathological variations in the nose. These variants include: deviated nasal septum, concha bullosa, paradoxical middle turbinate and uncinate process insertion (to lamina papyrecea or roof of ethmoid or middle turbinate). We also compare between them according to presence of retention cyst in CT in contralateral side In the cases with deviated nasal septum, the septal deviation was seen if it is towards the side of the lesion or towards the opposite side according to its convexity. We also evaluate the sclerosis on thickening of the bony wall of the para nasal sinus as an indication of chronic inflammation. |
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 538-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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