Studying the effect of adenomyosis on the subendometrial blood flow and Junctional zone measurement in comparison to normal subjects.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000693628
• Date of registration: 02/07/2014
• Prospective Registration: Yes
• Primary sponsor: Eman Elkattan
• Public title: Studying the effect of adenomyosis on the subendometrial blood flow and Junctional zone measurement in comparison to normal subjects.
• Scientific title: comparative study of the subendometrial vascular indices and junctional zone measurement in women with adenomyosis and women without using ultrasound 3D power Doppler
• Date of first enrolment: 05/07/2014
• Target sample size: 120
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614000693628.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: A/Prof Eman Elkattan

• Name: A/Prof Eman Elkattan

Key inclusion & exclusion criteria

Inclusion criteria: -women with ultrasound diagnosis of adenomyosis only and scheduled for hysterectomy confirmed by histopathology
-women with ultrasound that confirms normal pelvic study and are asymptomatic and age matched
Exclusion criteria: -women with combined adenomyosis and fibroids
-women with fibroid or adenomyosis and are not scheduled for hysterectomy
-women with fibroids

Age minimum: 35 Years
Age maximum: 60 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

-women without adenomyosis and confirmed by histopathology;
-women without adenomyosis and confirmed by histopathology

Intervention(s)

trans-vaginal 3D power Doppler Ultrasonographic examination was done by Voluson 730 Registered trademark , Expert ultrasound system (GE Healthcare, Zipf, Austria) with transvaginal 5-to 9-MHz volume transducer,).The ultrasound examination was preformed prior to hysterectomy.

The ultrasonographic examination provided data related to vascular index (VI), flow index (FI), and vascular-flow index (VFI). The region of interest included the entire region of the endometrium.After evaluating the total color percentage and flow amplitude for the volume of interest, The virtual organ computer aided analysis (VOCAL) software for the analysis of 3D power Doppler histograms was used with computer algorithms to form indices of blood flow and vascularization. In the 730 system, there are four rotation angles to choose from, namely, 6 degrees, 9 degrees , 15 degrees , and 30 degrees, and because the entire data set is rotated about 180 degrees, these result in 30, 20, 12, and 6 planes, respectively, being available for measurements.We used rotation angle 30 degrees in this study .That means rotation in 6 planes manually.The approxiamate time of the test from 15-20 minutes.

Primary Outcome(s)

the 3D power doppler vascular indices of the endometrium in cases with dysfunctional bleeding who have adenomyosis on pathology (measurements of VI,FI,VFI indices)[6 months post hysterectomy]

-the 3D power doppler vascular indices of the endometrium in cases with dysfunctional bleeding who don't have fibroids or adenomyosis on pathology (measurements of VI,FI,VFI indices)[6 months post hysterectomy]

Secondary Outcome(s)

the 3D power doppler vascular indices of the endometrium in cases with adenomyosis who are symptomatic (measurements of VI,FI,VFI indices)[6 months post hysterectomy]

the 3D power doppler vascular indices of the endometrium in cases without fibroids or adenomyosis who are symptomatic (measurements of VI,FI,VFI indices)[6 months post hysterectomy]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Eman Elkattan