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临床试验/NCT01833871
NCT01833871Unknown2 期

Uterine Artery Doppler and Three Dimensional Power Doppler in the Diagnosis of Myometrial Masses

Cairo University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年2月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
120
试验地点
1
主要终点
Uterine artery doppler indices in fibroids in relation to adenomyosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

myometrial fibroid/adenomyoma

Experimental

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.

干预措施: Three dimensional Power Doppler to the myometrial mass (Other)

myometrial fibroid/adenomyoma

Experimental

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.

干预措施: Uterine artery Doppler (Other)

结局指标

主要结局

Uterine artery doppler indices in fibroids in relation to adenomyosis

时间窗: 9 months

Uterine artery doppler indices(RI,PI) in fibroids in relation to adenomyosis

Power Doppler Vascular indices

时间窗: 9 months

The ultrasonographic examination will provide data related to lesion size, lesion volume, uterine artery doppler indices and 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Elkattan

Dr.

Cairo University

研究点 (1)

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