Paranasal SinusesNCT06683859
Variants of Paranasal Sinuses in Nepali Population
An observational study of Paranasal Sinuses, run by Grande International Hospital, Nepal at 1 site in Nepal.
Trial summary
The variants of paranasal sinuses (PNS)and nasal cavity are of clinical importance since some variants are susceptible to recurrent infection. Moreover, during functional endoscopic sinus surgery, knowledge of anatomy is of utmost importance in order to prevent injury of vital structures like optic nerves, carotid… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Paranasal Sinuses
- How many people
- 360 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2022to 5 Nov 2024
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Nepali Population
Who may be able to join
- CT scan of PNS of patients > 13 years referred for various reasons.
- CT scan of Head referred to our department for various reasons.
Who cannot join
- CT of PNS and head done for evaluation of trauma and tumors
- CT of Patients age less than 13 years .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Critical Anatomical Variants in Preoperative Computed Tomography of Paranasal Sinuses and Nasal Cavity : a Study in a Tertiary Care Center of Nepal
The variants of paranasal sinuses (PNS)and nasal cavity are of clinical importance since some variants are susceptible to recurrent infection. Moreover, during functional endoscopic sinus surgery, knowledge of anatomy is of utmost importance in order to prevent injury of vital structures like optic nerves, carotid arteries etc. However, there is lack of study enrolling adequate number of patients in our country. Critical variants are often underreported by radiologists. Thus, it is imperative to know true prevalence of different anatomical variants.
Read the detailed description
The nasal cavity and paranasal sinuses(PNS) together constitute single anatomical and functional unit. There are different anatomical variants of paranasal sinuses and nasal cavity. This is the anatomical structure with most variation and computed tomography(CT) is frequently done to evaluate anatomy of PNS and nasal cavity. Knowledge of anatomical variants is important for early diagnosis of pathology in the region and to prevent complications during functional endoscopic sinus surgery(FESS). Different anatomical variants frequently seen in CT of PNS and nasal cavity include deviated nasal septum, bony spur, concha bullosa, paradoxical nasal turbinate, agger nasi cells, bulla ethmoidalis, haller cells, onodi cells, different degree of pneumatization of sphenoid sinus etc. Anatomical variation of these structures differs in different ethnic groups. Some variants like onodi cells, complete sellar pneumatization of sphenoid sinus, anterior ethmoid artery traversing ethmoid air cells, dehiscent optic nerve and carotid artery pose structure around them into risk during surgery. If exact prevalence of these anatomical variations is known, it becomes easy for surgeons to approach lesions in the area easily. Some variants like haller cells, ager nasi cells, bulla ethmoidalis block osteomeatal complex and drainage pathway of frontal sinuses. Sinusitis may be refractory to medications due to these variants. We could find three studies done in our country and the sample size ranges from 76 to 218. We are aiming for larger study which could provide more accurate picture of prevalence of different anatomical variants. CT of PNS is done frequently in our hospital and we rarely collect data from the images for research purpose. There would be utilization of those data as well. Patient need not pay extra or receive extra radiation for the study. We think the study is very noble and would be a great help for surgeons and clinicians in the country.
- Conditions
- Paranasal Sinuses
- Keywords
- Computed Tomography (CT), Paranasal Sinuses (PNS), Functional Endoscopic Sinus Surgery(FESS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paranasal sinus of patients with no obvious pathology | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Anatomical variants of paranasal sinuses in Nepali population
Prevalence of agger nasi cell, haller cell, different types of olfactory fossa
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 posted12 Nov 2024
- Study start1 Apr 2022
- Primary completion1 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paranasal SinusesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grande International Hospital, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PRAJWAL DAHAL, Grande International Hospital, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683859
- Sponsor's protocol ID
- 17/2023
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I, the principal investigator choose not to share the plan
Publications
Shrestha KK, Acharya K, Joshi RR, Maharjan S, Adhikari D. Anatomical Variations of the Paranasal Sinuses and the Nasal Cavity. Nepal Med Coll J. 2019 Mar 31;21(1):7-11
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Anatomical Variants in Preoperative Computed Tomography of Paranasal Sinuses and Nasal Cavity : a Study in a Tertiary Care Center of Nepal
- ClinicalTrials.gov ID
- NCT06683859
- Acronym / sponsor ID
- 17/2023
- Conditions
- Paranasal Sinuses
- Keywords
- Computed Tomography (CT), Paranasal Sinuses (PNS), Functional Endoscopic Sinus Surgery(FESS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Grande International Hospital, NepalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 12 Nov 2024 (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 variants of paranasal sinuses (PNS)and nasal cavity are of clinical importance since some variants are susceptible to recurrent infection. Moreover, during functional endoscopic sinus surgery, knowledge of anatomy is of utmost importance in order to prevent injury of vital structures like optic nerves, carotid arteries etc. However, there is lack of study enrolling adequate number of patients in our country. Critical variants are often underreported by radiologists. Thus, it is imperative to know true prevalence of different anatomical variants.
Detailed description
The nasal cavity and paranasal sinuses(PNS) together constitute single anatomical and functional unit. There are different anatomical variants of paranasal sinuses and nasal cavity. This is the anatomical structure with most variation and computed tomography(CT) is frequently done to evaluate anatomy of PNS and nasal cavity. Knowledge of anatomical variants is important for early diagnosis of pathology in the region and to prevent complications during functional endoscopic sinus surgery(FESS). Different anatomical variants frequently seen in CT of PNS and nasal cavity include deviated nasal septum, bony spur, concha bullosa, paradoxical nasal turbinate, agger nasi cells, bulla ethmoidalis, haller cells, onodi cells, different degree of pneumatization of sphenoid sinus etc. Anatomical variation of these structures differs in different ethnic groups. Some variants like onodi cells, complete sellar pneumatization of sphenoid sinus, anterior ethmoid artery traversing ethmoid air cells, dehiscent optic nerve and carotid artery pose structure around them into risk during surgery. If exact prevalence of these anatomical variations is known, it becomes easy for surgeons to approach lesions in the area easily. Some variants like haller cells, ager nasi cells, bulla ethmoidalis block osteomeatal complex and drainage pathway of frontal sinuses. Sinusitis may be refractory to medications due to these variants. We could find three studies done in our country and the sample size ranges from 76 to 218. We are aiming for larger study which could provide more accurate picture of prevalence of different anatomical variants. CT of PNS is done frequently in our hospital and we rarely collect data from the images for research purpose. There would be utilization of those data as well. Patient need not pay extra or receive extra radiation for the study. We think the study is very noble and would be a great help for surgeons and clinicians in the country.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paranasal sinus of patients with no obvious pathology | – | – |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nepali Population
Key inclusion criteria (2 listed)
- CT scan of PNS of patients > 13 years referred for various reasons.
- CT scan of Head referred to our department for various reasons.
Key exclusion criteria (2 listed)
- CT of PNS and head done for evaluation of trauma and tumors
- CT of Patients age less than 13 years .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Anatomical variants of paranasal sinuses in Nepali population
Time frame: 6 months
Prevalence of agger nasi cell, haller cell, different types of olfactory fossa
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 12 Nov 2024.
- BackgroundShrestha KK, Acharya K, Joshi RR, Maharjan S, Adhikari D. Anatomical Variations of the Paranasal Sinuses and the Nasal Cavity. Nepal Med Coll J. 2019 Mar 31;21(1):7-11
- Individual participant dataSharing planned: No. I, the principal investigator choose not to share the plan
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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 Paranasal Sinuses, run by Grande International Hospital, Nepal at 1 site in Nepal.
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 12 Nov 2024. 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 Nepal. 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?
Prevalence of Anatomical variants of paranasal sinuses in Nepali population (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683859, which also lists 1 linked publication.
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 12 Nov 2024.