This study's approval was obtained from the local ethics committee with decision number 2021/129, dated 22/12/2021. The study population consisted of patients and healthy volunteers presenting to the obstetrics and gynecology outpatient clinic. Informed consent was obtained from participants, and the study was conducted by the Declaration of Helsinki. Based on our power analysis, the sample size was set at a total of 95 participants, 19 for each group. The included women were divided as follows: As a control group, 19 healthy volunteers (group 1) who had no complaints and had no pathological findings at examination, and whose cervicovaginal smears (CVS) and human papillomavirus (HPV DNA) were normal, whose cervical biopsy was taken, and whose final pathological result of cervical biopsy was normal: 19 women (group 2), 19 women with low-grade squamous intraepithelial lesion (LSIL) (group 3), 19 women with high-grade squamous intraepithelial lesion (HSIL) (group 4), 19 women with cervical cancer as a result of cervical biopsy pathology (group 5). Exclusion criteria: Pregnant women, women with cervicovaginal infections, women taking oral contraceptives, women with uterocervical abnormalities, patients with inadequate medical records before and after colposcopy, patients who had undergone cervical surgery (conization, LEEP), women with a history of Emmet rupture during childbirth, women with a history of cerclage during pregnancy, and women who were unwilling to participate in the study.
Ultrasound and elastography examinations were routinely performed in patients with suspected cervical lesions. B-mode imaging and elastographic measurements were performed with the same ultrasound machine and transvaginal transducer. The resulting images and elastographic stiffness ratios were obtained by a single operator. During the study, the cervix was placed in the center of the screen in the sagittal plane. In the elastography images, the colors red (hard), blue (medium hard), and green (soft) were analyzed using software, and the elastography percentages of the total three colors were determined. Patients were asked to hold their breath, and the probe was stabilized for 3–5 seconds. After sufficient pressure was applied (light, repeated compression on the target area), the image was frozen after the sampling field was completely filled with color. A dual-mode screen was used to view B-mode and elastography images side-by-side on the instrument screen. A circular "Q-box' was placed in the image to measure tissue stiffness in m/s. Three Q-boxes were placed in the internal, midline, and external os, and their mean values were used to determine the degrees of elasticity.
Figure 1: B-mode and elastography combined view
Body mass index (BMI) calculated by dividing the body mass by the height of the woman in meters squared.
During colposcopy, the patient was placed in the dorsal lithotomy position by placing a speculum of appropriate size into the vagina and ensuring adequate visibility. The cervix and vagina were examined under white light without applying any solution. Then, a 3–5% concentration of acetic acid was applied to aid imaging. Because adequate images could not be obtained after applying acetic acid, a Lugol-Shiller solution was used to investigate whether abnormal findings were present. Data obtained after colposcopy were recorded, and biopsies were taken from regions deemed necessary.
Age, gravida, parity, menopausal status, mode of delivery, BMI, smoking, presence of additional diseases, previous surgery, habits, family history, smear, and HPV test results, colposcopy findings, final pathology results, uterine and cervical dimensions of included patients, and degree of hardness measured by cervical elastography was recorded.
STATISTICAL ANALYSIS
Data were completed by transfer to the Statistics Package for the Social Sciences (SPSS) program (version 21, SPSS, Inc., Chicago, IL). In analyzing the study data, frequency distributions (number, percentage) for categorical variables and descriptive statistics (mean, standard deviation, minimum, maximum) for numerical variables are reported. First, the normality tests were examined to fit the measured values to the normal distribution. One-way ANOVA and chi-square test were used for differences between groups regarding measured values. Pearson correlation analysis was used for the relationship between numerical measurements, and logistic regression analysis was used to determine the influencing factors. In addition, the cut-off value for disease risk for the measurement of mean cervical elastography hardness was determined by receiver operating curve analysis (ROC). p < 0.05 was accepted as significant.