跳至主要内容
临床试验/NCT03120078
NCT03120078终止不适用

Diagnostic Accuracy of Ultrasound for Adenomyosis, Development of Scoring System and Correlation With Various Pelvic Pathologies: a Prospective Study.

Texas Tech University Health Sciences Center, El Paso1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
2
试验地点
1
主要终点
Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms.

研究概览

简要总结

Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound clinic. An ultrasound will be obtained as part of the required clinical assessment before the patient undergoes a hysterectomy. The ultrasound images will be reviewed using Viewpoint reporting system-various sonographic features of adenomyosis will be reported detailed, including pelvic pathology, pelvic congestion syndrome etc. The histopathological examination will be done by assigned pathologist for accurate mapping/localizing the adenomyosis (appropriate section of uterus to defining localized versus generalized adenomyosis) on all patients diagnosed with adenomyosis on ultrasound. The ultrasound will be correlated with histopathology(which is the gold standard for diagnosis of adenomyosis). Scoring system for adenomyosis based on various sonographic features/clinical symptoms and their confirmation with histopathology will be developed.

详细描述

The association between adenomyosis, assisted reproductive technology (ART) outcomes and pregnancy complications is well established.

Adenomyosis uteri is a common gynecologic disorder with unclear etiology, characterized by the presence of hetero- topic endometrial glands and stroma in the myometrium with adjacent smooth muscle hyperplasia, defined histopathologically. Uterine adenomyosis is relatively frequent, and the diagnosis is more often made in multiparous patients in their fourth and fifth decade of life. It has been noted in 20% to 30% of the general female population and in up to 70% of hysterectomy specimens, depending on the definition used.

Accurate diagnosis and localization of the disease is important, in particular when fertility conservation is warranted. Management options include medical therapy and surgery. Medical therapies target symptomatic relief and include oral contraceptive agents, progestin therapy including the levonorgestrel-releasing intrauterine system, danazol, gonadotropin-releasing hormone agonists, and aromatase inhibitors. More uterine sparing surgical options are investigated for treatment of adenomyoisis. Surgical management can be divided into uterine sparing options such as hysteroscopic or laparoscopic resection of focal disease, endometrial ablation, uterine artery embolization, and MRgFUS, or definitive treatment via hysterectomy. The sensitivity and specificity of MRI in diagnosing adenomyosis range from 88% to 93% and 67% to 91%, respectively. Ultrasound has limitation especially when myomas are associated with adenomyosis in 36% to 50% of cases, making MRI an ideal imaging method in that scenario. The sensitivity of ultrasound to detect adenomyosis ranges from 65% to 81%, and specificity ranges from 65% to 100%. A recent meta-analysis on the accuracy of ultrasound in the diagnosis of adenomyosis demonstrated sensitivity of 82.5% (95% confidence interval, 77.5-87.9) and specificity of 84.6% (95% confidence interval, 79.8-89.8), with a positive likelihood ratio of 4.7 (3.1-7.0) and negative likelihood ratio of 0.26 (0.18-0.39), comparable to MRI.

Adenomyosis is a heterogeneous entity and thus its sonographic appearance is also variable. The variation in the degree of invasion and the heterogeneity in the reaction of surrounding tissue account for the ultrasound findings of adenomyosis. It manifests most commonly as a diffuse disease involving the entire myometrium and commonly involves the posterior uterine wall. It can also present as a localized focal entity known as nodular adenomyosis or an adenomyomas.

Following are common sonographic features of adenomyoisis.

研究设计

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

入排标准

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

入选标准

  • 18 years or older but 60 years or less.
  • Undergoing hysterectomy for AUB or pelvic pain

排除标准

  • known cause of AUB or pelvic pain

结局指标

主要结局

Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms.

时间窗: Duration of Study

Sonographic features

次要结局

  • Menstrual bleeding questionnaire(Duration of Study)
  • Prevalence of coexisting pathology.(Duration of Study)
  • Review the diagnostic accuracy of ultrasound with adenomyosis.(Duration of study)

研究者

发起方
Texas Tech University Health Sciences Center, El Paso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sushila Arya

Assistant Professor

Texas Tech University Health Sciences Center, El Paso

研究点 (1)

Loading locations...

相似试验