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Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts

Primary Purpose

Ovarian Endometrioma

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound elastography
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Endometrioma focused on measuring ultrasound elastography

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

evaluate the value of ultrasound elastography in dignosis of endometriomas

evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts

Arm Description

evaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks

revaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 8, 2021
Last Updated
October 22, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05104086
Brief Title
Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts
Official Title
Ultrasound Elastography in Differentiation of Endometriomas and Hemorrhagic Ovarian Cysts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 25, 2020 (Actual)
Primary Completion Date
November 25, 2021 (Anticipated)
Study Completion Date
December 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma
Keywords
ultrasound elastography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Investigator
Masking Description
Single investigator
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
evaluate the value of ultrasound elastography in dignosis of endometriomas
Arm Type
Active Comparator
Arm Description
evaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks
Arm Title
evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts
Arm Type
Active Comparator
Arm Description
revaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values
Intervention Type
Device
Intervention Name(s)
ultrasound elastography
Intervention Description
strain ratio and resistivity index
Primary Outcome Measure Information:
Title
evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts
Description
the cut of value of strain ratio in diagnosis of endometrioma and ovarian hemorrhagic cyst
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hala hafez, resident
Phone
00201027292006
Email
halahafez193@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
alaa mosbah, professor
Email
alaamosbah@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa mosbah, professor
Organizational Affiliation
Mansoura university faculty of medicine,obestetric and gynecology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hala hafez, resident
Phone
01027292006
Email
halahafez193@gmail.com
First Name & Middle Initial & Last Name & Degree
alaa mosbah, professor
Email
alaamosbah@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts

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