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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Nepal
    • Bagmati
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Paranasal sinus of patients with no obvious pathology

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grande International Hospital, Nepal

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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