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临床试验/NCT05695690
NCT05695690尚未招募不适用

Role of Ultrasound in Uterine Fibroids Characterization Compared With MRI Using FIGO Classification System

Assiut University0 个研究点目标入组 43 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
43
主要终点
Comparison of MRI with Ultrasonography in characterization of uterine fibroids using FIGO classification system

研究概览

简要总结

Evaluation of diagnostic accuracy of ultrasound in uterine fibroid characterization compared with MRI using FIGO classification

详细描述

Uterine fibroids, also known as uterine leiomyomata or myomas, are the most common gynecologic tumors occurring in 20-30% of women of reproductive age and in up to 80% of all women.

Leiomyomas have a wide spectrum of clinical presentations, but are mostly asymptomatic. Submucosal leiomyomas are more commonly associated with symptoms such as AUB, dysmenorrhea, infertility, and recurrent pregnancy loss. Subserosal leiomyomas can cause gastrointestinal or genitourinary symptoms related to size such as constipation, urinary retention, urinary frequency and urgency, or bladder and bowel incontinence.

Fibroids are monoclonal smooth muscle tumors arising from the myometrium. While benign, their growth is dependent on estrogen and progesterone levels, and thus fibroids may enlarge with pregnancy and use of oral contraceptives and regress during menopause.

Ultrasonography (USG) is the first-line imaging modality for any suspected structural anomaly of the female pelvis as well as the most appropriate imaging modality for abnormal uterine bleeding. USG has high sensitivity and specificity in diagnosing leiomyomas, but can vary with the experience of the operator performing the USG, ranging from 65 to 99%.

Pelvic USG usually consists of a combined approach to include both transabdominal (TAS) and transvaginal (TVUS) imaging. TVUS is generally considered to be more sensitive and specific with greater contrast and spatial resolution when compared to TAS. TVUS is more useful in obese patients, patients with a large amount of bowel gas, and in patients with incomplete bladder filling, all of which lower the sensitivity of TAS. TAS, on the other hand, is helpful in females with a larger uterus that extends superiorly from the pelvis and cannot be completely visualized in the field of TVUS. TAS provides an anatomic overview to better estimate overall uterine size and visualize the fundus in such cases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • All females known or clinically suspected to have uterine fibroids & fit for the MRI examination.

排除标准

  • Patients with metallic prosthesis which are not MRI compatible.
  • Patients refused the examination.
  • Patients who suffer from claustrophobia.
  • Pregnant women especially in the first trim

结局指标

主要结局

Comparison of MRI with Ultrasonography in characterization of uterine fibroids using FIGO classification system

时间窗: Baseline

Evaluation of diagnostic accuracy of ultrasound in uterine fibroid characterization compared with MRI using FIGO classification

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

Ashraqat Mohamed Sherif

Principal Investigator

Assiut University

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