Antrochoanal PolypNCT05989919
Nasal Anatomical and Pathological Variants in Patients With Antrochoanal Polyps
An observational study of Antrochoanal Polyp, run by Minia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antrochoanal Polyp
- What is being tested?
- CT scan for nose and paranasal sinuses
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 30 Aug 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study participants were recruited from patients complaining from unilateral sinonasal disease attending our outpatient clinic.
Who may be able to join
- radiologically diagnosed based on CT nose and PNS.
- histopathologically diagnosed as ACP.
Who cannot join
- patients with history of maxillofacial trauma.
- patients who had previous nasal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Antrochoanal Polyp
- Being tested
- CT scan for nose and paranasal sinuses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan for nose and paranasal sinusesOther
CT scan for nose and paranasal sinuses
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with antrochoanal polyps Receives: Other: CT scan for nose and paranasal sinuses | |
| control group | patients with unilateral sinonasal disease other than antrochoanal polyps Receives: Other: CT scan for nose and paranasal sinuses |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of anatomical and pathological variants in CT scan and endoscopic examination
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start20 Dec 2022
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antrochoanal PolypStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisara Mohamed, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989919
- Sponsor's protocol ID
- 538-2022
- Status last verified
- Nov 2023
- First submitted
- 5 Aug 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Anatomical and Pathological Variants in Patients With Antrochoanal Polyps
- ClinicalTrials.gov ID
- NCT05989919
- Acronym / sponsor ID
- 538-2022
- Conditions
- Antrochoanal Polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: CT scan for nose and paranasal sinusespatients with antrochoanal polyps |
| control group | – | Other: CT scan for nose and paranasal sinusespatients with unilateral sinonasal disease other than antrochoanal polyps |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study participants were recruited from patients complaining from unilateral sinonasal disease attending our outpatient clinic.
Key inclusion criteria (2 listed)
- radiologically diagnosed based on CT nose and PNS.
- histopathologically diagnosed as ACP.
Key exclusion criteria (2 listed)
- patients with history of maxillofacial trauma.
- patients who had previous nasal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scan for nose and paranasal sinusesCT scan for nose and paranasal sinuses | Other | control group, study group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antrochoanal Polyp, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of anatomical and pathological variants in CT scan and endoscopic examination (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.