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临床试验/NCT06718088
NCT06718088招募中不适用

Risk Factors Associated With The Progression Of Adenomyosis

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
258
试验地点
1
主要终点
Progression of adenomyosis

研究概览

简要总结

Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of endometrial glands and stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding.

Transvaginal ultrasound (TVUS) is considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis.

Although adenomyosis is a very common condition among patients of childbearing age, its natural course is still debated. Some studies have evaluated the role of hormonal treatments (systemic or local oestrogen or progestin-based) on adenomyosis, which have been effective in controlling symptoms such as pelvic pain and abnormal uterine bleeding. Despite all this, no evidence is available on the progression of adenomyosis and the factors that may influence its progression over time. The aim of this study is therefore to assess the progression of adenomyosis and associated risk factors using transvaginal ultrasound.

详细描述

Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of endometrial glands and stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding.

Transvaginal ultrasound is considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis.

The goal of formulating a recognised and unified terminology for the description of ultrasound criteria for the diagnosis of adenomyosis was achieved by the Morphological Uterus Sonographic Assessment (MUSA) consensus.

The MUSA consensus consists of a list of ultrasound features associated with adenomyosis, namely:

  • globular uterus: uterus with a more spherical conformation and more slender bottom than normal. The definition of a 'globular uterus' is currently subjective and there are no quantitative uterine biometric parameters available to differentiate a uterus with adenomyosis from a uterus not affected by the disease (normal or fibromatous uterus).
  • asymmetric thickening of the uterine walls;
  • inhomogeneous eco-structure due to the presence of multiple hyperechogenic striae intermixed with hypoechogenic striae (thin shadow cones) giving the typical ultrasound appearance described as 'rain in the forest' or 'fan-shaped shadowing';
  • cystic spaces or non-vascularised intra-myometrial anecogenic lacunae, often surrounded by a hyper-echogenic halo, caused by glandular ectasia;
  • hyperechogenic islands deepening in the myometrium, expression of the presence of islands of ectopic endometrial tissue;
  • subendometrial lines and spicules;
  • intralesional and irregular vascularisation of the myometrium (vessels penetrate in a rectilinear within adenomyomas or foci of adenomyosis);
  • poor definition of the endometrium/myometrium junction (JZ);
  • thickening, irregularities and interruptions of the JZ.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged between 18 and 55 years;
  • Presence of at least two direct and indirect signs according to the MUSA classification
  • Obtaining informed consent

排除标准

  • Patients undergoing hysterectomy;
  • Virgo patients;
  • Patients reporting intolerance to transvaginal ultrasound;
  • Gynaecological oncology;
  • Recent pregnancy or childbirth (within 6 months)

结局指标

主要结局

Progression of adenomyosis

时间窗: At 12, 24, 36 and 48 months

Risk of progression of adenomyosis and the risk factors associated with progression in patients with ultrasound diagnosis of adenomyosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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