Clinical trial NCT05104086: Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts
Official title: Ultrasound Elastography in Differentiation of Endometriomas and Hemorrhagic Ovarian Cysts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Endometrioma
Keywords: ultrasound elastography
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
affiliation: Mansoura university faculty of medicine,obestetric and gynecology department
name: Alaa mosbah, professor
role: PRINCIPAL_INVESTIGATOR
References: