- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06683859
Variants of Paranasal Sinuses in Nepali Population
November 9, 2024 updated by: PRAJWAL DAHAL, Grande International Hospital, Nepal
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bagmati
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Kathmandu, Bagmati, Nepal, 44600
- Tokha Road, Dhapasi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Nepali Population
Description
Inclusion Criteria:
- CT scan of PNS of patients > 13 years referred for various reasons.
- CT scan of Head referred to our department for various reasons.
Exclusion Criteria:
- CT of PNS and head done for evaluation of trauma and tumors
- CT of Patients age less than 13 years .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Paranasal sinus of patients with no obvious pathology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
November 1, 2024
Study Completion (Actual)
November 5, 2024
Study Registration Dates
First Submitted
November 7, 2024
First Submitted That Met QC Criteria
November 9, 2024
First Posted (Estimated)
November 12, 2024
Study Record Updates
Last Update Posted (Estimated)
November 12, 2024
Last Update Submitted That Met QC Criteria
November 9, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 17/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
I, the principal investigator choose not to share the plan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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