Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000139673
Ethics application status
Approved
Date submitted
3/01/2014
Date registered
5/02/2014
Date last updated
4/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Studying the effect of fibroids versus adenomyosis on the ovarian artery blood flow in comparison to normal subjects.
Scientific title
comparative study of the ovarian vascular indices in women with fibroids and adenomyosis and women without using ultrasound 3D power Doppler
Secondary ID [1] 283843 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
-women with fibroid uterus detected by ultrasound and confirmed by histopathology
 290816 0
-women with adenomyosis detected by ultrasound and confirmed by histopathology 290817 0
Condition category
Condition code
Reproductive Health and Childbirth 291186 291186 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 ovary.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.
Intervention code [1] 288523 0
Diagnosis / Prognosis
Comparator / control treatment
healthy asymptomatic women who are age matched and the 2D ultrasound image shows normal pelvic study and they will have trans-vaginal 3D power doppler study of the ovaries as the control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291173 0
-the 3D power doppler vascular indices of the ovaries in cases with fibroids (measurements of VI,FI,VFI indices)
Timepoint [1] 291173 0
9 months post hysterectomy
Primary outcome [2] 291174 0
-the 3D power doppler vascular indices of the ovaries in cases with adenomyosis (measurements of VI,FI,VFI indices)
Timepoint [2] 291174 0
9 months post hysterectomy
Secondary outcome [1] 306184 0
the 3D power doppler vascular indices of the ovaries in cases with fibroids who are symptomatic (measurements of VI,FI,VFI indices)
Timepoint [1] 306184 0
9 months post hysterectomy
Secondary outcome [2] 306185 0
the 3D power doppler vascular indices of the ovaries in cases with adenomyosis who are symptomatic (measurements of VI,FI,VFI indices)
Timepoint [2] 306185 0
9 months post hysterectomy

Eligibility
Key inclusion criteria
-women with ultrasound diagnosis of fibroids only and scheduled for hysterectomy confirmed by histopathology
-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
Minimum age
25 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-women with combined adenomyosis and fibroids
-women with fibroid or adenomyosis and are not scheduled for hysterectomy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
3/07/2014
Date of last participant enrolment
Anticipated
24/10/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 5713 0
Egypt
State/province [1] 5713 0
Cairo

Funding & Sponsors
Funding source category [1] 288495 0
Self funded/Unfunded
Name [1] 288495 0
Eman Elkattan
Country [1] 288495 0
Egypt
Primary sponsor type
Individual
Name
Eman Elkattan
Address
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country
Egypt
Secondary sponsor category [1] 287198 0
None
Name [1] 287198 0
Address [1] 287198 0
Country [1] 287198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290354 0
Cairo University
Ethics committee address [1] 290354 0
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Ethics committee country [1] 290354 0
Egypt
Date submitted for ethics approval [1] 290354 0
Approval date [1] 290354 0
Ethics approval number [1] 290354 0

Summary
Brief summary
we studied the ovarian vascular indices in women who were diagnosed of having either fibroids or adenomyosis by ultrasound and who had hysterectomy in comparison for age-matched women who have a free ultrasound examination
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45290 0
A/Prof Eman Elkattan
Address 45290 0
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country 45290 0
Egypt
Phone 45290 0
+201222854159
Fax 45290 0
Email 45290 0
[email protected]
Contact person for public queries
Name 45291 0
Eman Elkattan
Address 45291 0
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country 45291 0
Egypt
Phone 45291 0
+201222854159
Fax 45291 0
Email 45291 0
[email protected]
Contact person for scientific queries
Name 45292 0
Eman Elkattan
Address 45292 0
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country 45292 0
Egypt
Phone 45292 0
+201222854159
Fax 45292 0
Email 45292 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.