ASSESMENT OF ADNEXAL LESIONS USING ULTRASOUND BY O-RADS APPROACH.

Title of my Study is "ASSESMENT OF ADNEXAL LESION USING ULTRASOUND BY O-RADS APPROACH"

 Type of study: Prospective Observational study.

Patient age-group and diagnosis:  Women >18 years with adnexal lesions

Procedure of study:

Patients with provisional/ clinical diagnosis of adnexal lesion will be enrolled for the study. Details of the study will be explained to the subjects. Written, Informed consent will be obtained. A detailed menstrual, obstetric and medical history of each patient will be taken.Ultrasound-Pelvis will be performed using an Ultrasound machine at Fortis hospital, Mulund and following features like size, type, locularity, margins, number of papillary projections, Color score on Doppler in the lesions will be assessed, based on which O-RADS US category/score will be evaluated.

 The above data will be analyzed for the complications, primary outcome, and secondary outcome

Primary Outcome : Spectrum of Ultrasound imaging features of adnexal lesions using O-RADS approach.

Secondary Outcome: Histopathological/MRI correlation with Ultrasound findings.

Based on the outcome what type of analysis and data collection:

The duration of study will be from IEC approval date till 18 months and 52 no. of patients will be included in this study.

All the data will be noted down in a pre-designed study proforma.

After data collection, data entry will be done in Excel.

Data analysis will be done with the help of statistical software SPSS Version 25.0.

All the qualitative data will be represented in the form of frequency and percentage.

Quantitative data will be represented using Mean ± SD and Median & IQR (Interquartile range).

Analysis of sensitivity, specificity, positive predictive value and negative predictive value will be done for Ultrasound versus clinical findings (biopsy/ surgery/histopathology).

A p-value < 0.05 was taken as level of significance.

Accuracy and Descriptive statistical analysis will be carried out in the present study. Diagnostic statistics such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy will be used to find the correlation of Ultrasound with Histopathology (final diagnosis).

Comparison of proportions will be done using Fisher’s Exact test and association between two non-parametric variables will be done using Pearson Chi-square test. The final data will be presented in the form of tables and graphs.

Post Data analysis, Results obtained may be published in journal.

Patient Information Sheet will be provided to all patients. Patient Information Sheet will contain methodology, risks, and benefits of the study and before enrolling patients in the study, Informed Consent will be taken from them. No active intervention will be done by the Primary Investigator.

The study will be done after approval from Institutional Ethics Committee and registeration of the trail is granted