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临床试验/NCT06223464
NCT06223464进行中(未招募)不适用

Evaluation of the Relationship Between Adenomyosis and Elastographic Properties of the Cervix

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
130
试验地点
1
主要终点
Diagnosis of Adenomyosis

研究概览

简要总结

This study aims to evaluate the potential of cervical elastography, a non-invasive method, in the accurate diagnosis and clinical course of adenomyosis. Cervical elastography is an imaging method that measures the elasticity properties of cervical tissue using ultrasound technology. This method may be helpful in providing information about the development and clinical course of adenomyosis.

详细描述

Adenomyosis is the proliferation of endometrial gland and stroma within the myometrium of the uterus. Its prevalence varies between 10% and 40% in epidemiologic data. It often causes painful menstruation, pelvic pain and other gynecologic symptoms. While adenomyosis may be mild in some patients, it may show infiltrative and severe invasion in others. Advanced cases may be resistant to medical treatment and may affect nearby organs, which makes surgical treatment quite complicated. Therefore, early diagnosis of the disease is important for clinical practice. Global enlargement of the uterus, dysmenorrhea (painful menstruation), menorrhagia, abnormal uterine bleeding and pelvic pain are considered typical clinical symptoms of adenomyosis. However, it should be kept in mind that these symptoms coincide with the histologic diagnosis in a very small proportion of cases, 22% to 65%. The diagnosis and treatment of adenomyosis is complex and therefore there is a need to develop better diagnostic tools and treatment strategies for the management of patients. In this context, new imaging modalities such as cervical elastography may be of potential importance.

Our main hypothesis is that cervical elastography values will be significantly higher in patients with adenomyosis compared to patients without adenomyosis. Our secondary hypothesis is that cervical elastography values will be related to the severity and process of adenomyosis and may be an indicator to predict the symptoms and complications of adenomyosis.

The advantages of Cervical Elastography are the following:

It is non-invasive: Cervical Elastography is performed using ultrasound technology and has no known harm. It stands as a potentially safe method compared to existing invasive tests.

Cost-effective and easy to perform: Cervical Elastography is a procedure performed using existing ultrasound equipment at no separate cost. Therefore, it can be easily performed and repeated in clinical settings.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients between 18-45 years of age who volunteered and consented to the reproductive period study
  • Patients diagnosed with adenomyosis using MUSA criteria

排除标准

  • Pregnancy status
  • Pelvic/Cervical infection, pathology and anomalies
  • History of cervical surgery
  • Diagnosis and findings of systemic disease
  • Chronic drug use
  • Advanced maternal obesity preventing measurement

结局指标

主要结局

Diagnosis of Adenomyosis

时间窗: 2 months

MUSA Criteria

次要结局

  • Diagnosis of Adenomyosis-Cervical Elastography(4 months)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dilara SARIKAYA KURT

Specialist Doctor

Ankara Etlik City Hospital

研究点 (1)

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