An observational study in Thyroid Nodule, sponsored by Tribhuvan University, Nepal. Completed at 1 site in Nepal. Open to participants aged 20 Years to 66 Years. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Tribhuvan University, Nepal · Observational
A thyroid nodule is a discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are benign, with only 10% to 15% harboring cancer. This is a prospective study conducted at the department of Ear, Nose and Throat - Head and Neck Surgery (ENT-HNS) of Shree Birendra Hospital , a tertiary heath care centre of Nepal. Individuals visiting ENT-HNS outpatient department with thyroid nodules had undergone Ultrasonography (USG) of neck followed by Fine-Needle Aspiration Cytology (FNAC) from the thyroid nodules. USG was reported by Thyroid Imaging Reporting and Data System(TIRADS) and FNAC by Bethesda system. Thereafter patients were planned either for surgery either total thyroidectomy or hemithyroidectomy. Post operative histopathology was correlated with preoperative FNAC and USG reports.
The main objective of this prospective cohort study is to know the correlation between pre- operative Bethesda with post- operative histopathology , pre - operative TIRADS with post operative Histopathology and comparison of combined scoring of Bethesda and TIRADS with histopathology report. It is of utmost importance to deep dive into thyroid nodules workup to detect malignant nodules, as the management aspect of benign and malignant nodules has a vast difference. Thyroid ultrasonography is useful for risk stratification of nodules, and American College of Radiology Thyroid Imaging Reporting and Data System (ACR TI-RADS) classification provides recommendations for fine-needle aspiration cytology (FNAC) based on objective ultrasonography features of these nodules. To maintain uniformity in reporting system FNA sample are categorized according to the Bethesda system. Total 42 participants who met the inclusion criteria were included in the study. Statistical Analysis was done using Statistical Package for the Social Science (SPSS) version 25. Analysis was done in the form of percentage and proportion and represented as table wherever necessary. Spearman's correlation coefficient was used to evaluate the correlation between Bethesda and TIRADS. Bethesda and histopathology and TIRADS and Bethesda system. The P value was set at \< 0.05 for statistical significance.
200 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.
This study's enrollment of 42 is below the median of 200 across 78 observational studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Tribhuvan University, Nepal is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All the participants with thyroid nodules who met the inclusion criteria within the study period were enrolled in the study . Total 42 participants were included in the study.
Exclusion Criteria:
Correlation between Bethesda and TIRADS system
Correlation between Bethesda and TIRADS system in terms of number of participants belonging to each category
Time frame: 6 months
Performance measure of Bethesda classification
Performance measure of Bethesda classification in terms of percentage
Time frame: 6 months
Performance measure of TIRADS classification
Performance measure of TIRADS classification in terms of percentage
Time frame: 6 months
Sex-wise Distribution of thyroid nodule
Sex-wise Distribution of thyroid nodule in percentage
Time frame: 6 months
Percentage of participants as per TIRADS classification
Percentage of participants as per TIRADS classification
Time frame: 6 months
Number of participants as per histopathological examination
Number of participants as per histopathological examination
Time frame: 6 months
Number of participants as per Bethesda classification
Number of participants as per Bethesda classification
Time frame: 6 months
Types of surgical procedures performed in terms of percentage
Types of surgical procedures performed in terms of percentage
Time frame: 6 months
Plan to share: No — There is no plan to share the individual participant data to protect the privacy of the participants.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tribhuvan University, Nepal