The Use of Doppler to Diagnose Myometrial Masses (3D)

Cairo University (CU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Uterine Masses

Treatments: Other: Uterine artery Doppler; Other: Three dimensional Power Doppler to the myometrial mass

Study type: Interventional

Funder types: Other

Identifiers

NCT01833871

Protocol200

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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120 participants in 1 patient group

myometrial fibroid/adenomyoma

Experimental group

Description:

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.

Treatment:

Other: Three dimensional Power Doppler to the myometrial mass

Other: Uterine artery Doppler