Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts

Not Applicable

• Conditions: Ovarian Endometrioma
• Interventions: Device: ultrasound elastography

• Registration Number: NCT05104086
• Lead Sponsor: Mansoura University

Brief Summary

To investigate the value of ultrasound elastography in differentiating endometriomas from ovarian hemorrhagic cysts

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-25
• Status Verified: 2021-09
• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-22
• Last Update Submitted: 2021-10-22
• Study First Posted: 2021-11-02
• Last Update Posted: 2021-11-02
• Primary Completion: 2021-11-25
• Study Completion: 2021-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Patient suspected to have endometrioma or hemorrhagic ovarian cysts.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
evaluate the value of ultrasound elastography in dignosis of endometriomas	ultrasound elastography	evaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks
evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts	ultrasound elastography	revaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values

Primary Outcome Measures

Name	Time	Method
evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts	4 weeks	the cut of value of strain ratio in diagnosis of endometrioma and ovarian hemorrhagic cyst

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt