NCT05419414

The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

In this prospective cohort study, the patients who were diagnosed with either uterine fibroid (control group) or adenomyosis (study group), were examined with transvaginal ultrasound and shear wave elastography. Definitive diagnosis was established by pelvic MRI. Shear wave elastography data of both groups were compared. Features of adenomyosis on transvaginal ultrasound were also recorded for study group.

Detailed description

In this prospective cohort study, the patients who applied to the Gynecology and Infertility Outpatient Clinic in Istanbul University Faculty of Medicine between October 2018 and October 2021 due to abnormal uterine bleeding, pelvic pain, infertility were evaluated. The patients who were diagnosed with adenomyosis and uterine myoma according to clinical evaluation were included and grouped. Clinical diagnosis were confirmed with contrast enhanced pelvic magnetic resonance imaging. No histopathological confirmation were included in this study. 34 patients were included in adenomyosis group and 31 patients were included in myoma group. All patients were evaluated with shear wave elastography; 3 regions of interest were selected for each elastographic evaluation. Average shear values were determined automatically; then, minimum and maximum mean shear values were recorded accordingly. Elastography values of both groups were compared in order to detect any statistically significant difference between 2 groups. In addition to elastography evaluation, the compatibility of transvaginal ultrasound and magnetic resonance were evaluated.

Conditions

• Adenomyosis
• Elastography
• Transvaginal Ultrasound
• Fibroid Uterus

Interventions

Type	Name	Description
DEVICE	Shear wave elastography	Both groups were examined with shear wave elastography.

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-10-01
• Completion: 2022-01-01
• First posted: 2022-06-15
• Last updated: 2022-06-15

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study