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临床试验/NCT05505331
NCT05505331Unknown不适用

Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross Sectional Observational Study

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
• The sensitivity and specificity of the 3D-Ultrasonography and MRI for the mapping of different types of symptomatic uterine fibroids according to the final intraoperative diagnosis

研究概览

简要总结

Three-Dimensional Ultrasonography versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross sectional Observational study

详细描述

  1. Introduction: Uterine fibroids are the most prevalent gynecologic tumors, affecting nearly (20-30) % of women in the reproductive age group[1] . Approximately 50% of fibroid cases are symptomatic [2] and presented by abnormal uterine bleeding, dysmenorrhea, pressure symptoms, infertility, and pregnancy loss[3]. Fibroids are myometrium-derived monoclonal smooth muscle cancers and their growth is reliant on estrogen and progesterone levels, thus fibroids usually expand during pregnancy or during the use of combined oral contraceptives, and shrink after menopause[4]. Two dimensional ultrasound is the initial test of choice to assess the presence of fibroids in symptomatic patients as it is simple, easy, available and informative [5]. Furthermore, ultrasonography may be sufficient for individuals having conservative therapy. However, Magnetic Resonance Imaging (MRI) gives a more precise evaluation of the quantity, location, and type of fibroids specially in cases with considerable uterine enlargement [6, 7] and submucosal fibroids. Furthermore, MRI can be utilized to differentiate between fibroids and their imitators, such as adenomyosis, ovarian neoplasms, and localized myometrial contractions [8].The introduction of 3D ultrasound in evaluating uterine fibroids appears to be an upcoming and promising prospect [9]. However, the evidence on the role of Three-Dimensional Ultrasonography for fibroid mapping is quite limited up till now.

  2. Aim of the study The aim of this study is to compare the accuracy of 3D ultrasound and MRI for fibroid mapping in women with symptomatic fibroids diagnosed by 2D ultrasound.

  3. Subjects and Methods

  1. Study type: Cross sectional observational study
  2. Inclusion criteria:

• Age group: child bearing period.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 52 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • • Age group: child bearing period.
  • Abnormal uterine bleeding
  • Dysmenorrhea
  • Pressure symptoms
  • Infertility
  • Pregnancy loss

排除标准

  • • The cardiac implantable electronic device (CIED)
  • Metallic intraocular foreign bodies
  • Implantable neurostimulation systems
  • Cochlear implants/ear implant
  • Drug infusion pumps
  • Cerebral artery aneurysm clips
  • Magnetic dental implants
  • Artificial limb

结局指标

主要结局

• The sensitivity and specificity of the 3D-Ultrasonography and MRI for the mapping of different types of symptomatic uterine fibroids according to the final intraoperative diagnosis

时间窗: from august 2022 to july 2023

comparing the ability of 3D-ultrasonography and MRI to detect the exact location of uterine myomas

次要结局

  • • The validity of 3D-ultrasonography and MRI of Fibroids for selecting the appropriate way of management(august 2023 to july 2023)

研究者

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

Mahmoud Ahmed Abdelmawgoud

mahmoud abdelMawjud

Sohag University

研究点 (1)

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