The Use of Doppler to Diagnose Myometrial Masses

NCT ID: NCT01833871

Last Updated: 2013-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-12-31

Brief Summary

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Colour Doppler sonography has also been evaluated in differentiating adenomyosis from fibroids. Two dimensional color Doppler ultrasound revealed that 87% of adenomyosis cases had vessel distributions different from those found in leiomyoma cases, in addition to a high pulsatility index (PI) .Adenomyotic lesions had randomly scattered vessels or intratumoral signals while leiomyomas usually had peripheral scattered or outer feeding vessels.

Detailed Description

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Because it is more sensitive, less angle-dependent, and not susceptible to aliasing , power Doppler Sonography has the potential to detect fluctuations in blood flow , with results superior to those of frequency-based color Doppler sonography, particularly in situations of low-velocity blood flow. Three dimensional power Doppler ultrasonography can be applied to differentiate between uterine adenomyosis and leiomyoma ,and it may reduce the number of false positives by detailed investigations.

Conditions

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Uterine Masses

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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myometrial fibroid/adenomyoma

Patients scheduled for myomectomy or hysterectomy with preoperative diagnosis of uterine myoma, adenomyosis or both by ultrasound .Trans-vaginal 3D power Doppler and uterine artery doppler will be done for all participants prior to surgery.

Group Type EXPERIMENTAL

Three dimensional Power Doppler to the myometrial mass

Intervention Type OTHER

Trans-vaginal 3D power Doppler Ultrasonographic examination will be done for all participants prior to surgery. The ultrasonographic examination will provide data related to lesion size, lesion volume, vascular location (location), vascular index (VI), flow index (FI), and vascular-flow index (VFI). The region of interest will include the entire region of the uterine mass. The virtual organ computer aided analysis (VOCAL) software for the analysis of 3D power Doppler histograms will be used with computer algorithms to form indices of blood flow and vascularization. All data will be collected and compared with the post operative histopathology results.

Uterine artery Doppler

Intervention Type OTHER

uterine artery Doppler indices(RI,PI) are measured for all cases with myometrial mass

Interventions

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Three dimensional Power Doppler to the myometrial mass

Trans-vaginal 3D power Doppler Ultrasonographic examination will be done for all participants prior to surgery. The ultrasonographic examination will provide data related to lesion size, lesion volume, vascular location (location), vascular index (VI), flow index (FI), and vascular-flow index (VFI). The region of interest will include the entire region of the uterine mass. The virtual organ computer aided analysis (VOCAL) software for the analysis of 3D power Doppler histograms will be used with computer algorithms to form indices of blood flow and vascularization. All data will be collected and compared with the post operative histopathology results.

Intervention Type OTHER

Uterine artery Doppler

uterine artery Doppler indices(RI,PI) are measured for all cases with myometrial mass

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 20 \& 60 years.
* Asymptomatic pts which discover the mass accidentally .
* Patients with symptoms like menorrhagia, menometrorrhagia, dysmenorrheal , abdominal masses.
* Patients scheduled for hysterectomy(abdominal/vaginal or Laparoscopic)
* Patients scheduled for myomectomy.

Exclusion Criteria

* Pregnant patients
* Age over 60 or under 20years.
* Conservative management (Non surgical)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Eman Elkattan

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman A. Elkattan, M.D,MRCOG

Role: CONTACT

00201222854159

Other Identifiers

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Protocol200

Identifier Type: -

Identifier Source: org_study_id

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