Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts
NCT ID: NCT05104086
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
33 participants
INTERVENTIONAL
2020-12-25
2021-12-25
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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evaluate the value of ultrasound elastography in dignosis of endometriomas
evaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks
ultrasound elastography
strain ratio and resistivity index
evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts
revaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values
ultrasound elastography
strain ratio and resistivity index
Interventions
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ultrasound elastography
strain ratio and resistivity index
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hemorrhagic cysts containing septations or mural nodules with detectable flow on Doppler ultrasonography
18 Years
52 Years
FEMALE
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Alaa mosbah, professor
Role: PRINCIPAL_INVESTIGATOR
Mansoura university faculty of medicine,obestetric and gynecology department
Locations
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Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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hala hafez, resident
Role: primary
alaa mosbah, professor
Role: backup
Other Identifiers
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MS.19.09.821
Identifier Type: -
Identifier Source: org_study_id