Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts

October 22, 2021 updated by: Mansoura University

Ultrasound Elastography in Differentiation of Endometriomas and Hemorrhagic Ovarian Cysts

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 52 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Alaa mosbah, professor, Mansoura university faculty of medicine,obestetric and gynecology department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2020

Primary Completion (Anticipated)

November 25, 2021

Study Completion (Anticipated)

December 25, 2021

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.19.09.821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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