Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts

Study Overview
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Brief Summary
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To investigate the value of ultrasound elastography in differentiating endometriomas from ovarian hemorrhagic cysts

Detailed Description
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The participants will be subjected to: Personal, Obstetric and gynecological History taking. Clinical examination. B-mode ultrasonography was performed to characterize the adnexal masses morphologically. Color Doppler ultrasound. Grayscale and elastographic ultrasound examination, which will be done using acoustic radiation force impulse (ARFI) imaging with virtual touch quantification (VTQ). Five consecutive measurements were recorded for each lesion from the region identified as the region of interest (ROI) and the median of these measurements was recorded as the shear wave velocity (SWV) value of the lesion. In virtual touch quantification (VTQ) the shear wave speed is expressed in m/s. Only numerical results will be taken into consideration. . Realtime elastographic and B-mode images simultaneously will appear as a two-panel image. Elastogram appeared in the region of interest (ROI) box to determine the target ovarian lesion and surrounding tissue, then elasticity colour code will be classified in 5 patterns : pattern 1, an absent or a very small hard area; pattern 2, hard area 45 per cent; pattern 4, peripheral hard and central soft areas; pattern 5, hard area occupying entire solid component with or without soft rim. Strain index will be analyzed, which will be obtained by comparing the absolute strain value of solid component of ovarian cyst with that of surrounding soft tissue. The invistigator will reevaluate the lesions 4 weeks after the initial assessment to see the possible changes in the size and/or configuration of the lesions with B-mode and elastographic ultrasonography. Lesion will be evaluated as endometriomas and referred for surgery when shows no significant changes in size and configuration. Hemorrhagic cyst diagnosis will be made if the lesion had resolved on follow-up.

Official Title
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Ultrasound Elastography in Differentiation of Endometriomas and Hemorrhagic Ovarian Cysts

Conditions
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Ovarian Endometrioma

Intervention / Treatment
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* Device: ultrasound elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient suspected to have endometrioma or hemorrhagic ovarian cysts. Exclusion Criteria: Simple cysts which were defined as a sonolucent thin-walled (<3 mm thick) cyst larger than 3 cm in diameter without septations or papillary projections [12]. Hemorrhagic cysts containing septations or mural nodules with detectable flow on Doppler ultrasonography

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: evaluate the value of ultrasound elastography in dignosis of endometriomas<br>evaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks | Device: ultrasound elastography<br>* strain ratio and resistivity index<br>|
| Active Comparator: evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts<br>revaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values | Device: ultrasound elastography<br>* strain ratio and resistivity index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts | the cut of value of strain ratio in diagnosis of endometrioma and ovarian hemorrhagic cyst | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound elastography