Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%)
研究概览
简要总结
Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.
The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis.
Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized.
Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes.
Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology.
The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1.
NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis
详细描述
Diagnosis of Adenomyosis with 3D and 2D transvaginal ultrasound. Prospective study of a consecutive series of 101 patients that are scheduled for hysterectomy and suffer from bleeding disorders, chronic pelvic pain, dysmenorrhea or dyspareunia. All patients will undergo transvaginal 2D- ultrasound, 3D-ultrasound and power doppler (PD)-ultrasound (TVU), magnetic resonance imaging of the pelvic organs (MRI) and hysterectomy.
We will investigate the specificity and sensitivity of 3D and 2D transvaginal ultrasound in the diagnosis of adenomyosis and compare data with MRI and histopathology, which is the gold standard by today. In addition, we will collect anamnestic information that might point to risk factors or connections to prior obstetrical complications and medicine use. In our study the pathologist will not be blinded to our ultrasound findings, and we want to investigate if this will raise the sensitivity of histology findings of adenomyosis.
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
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women aged 30 - 50 years old
- •scheduled for vaginal, abdominal or laparoscopic total hysterectomy
- •one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia
- •junction zone definable
排除标准
- •postmenopausal women,
- •pregnancy
- •gynecological cancer
- •GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy
- •junctional zone not identifiable
结局指标
主要结局
Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%)
时间窗: within 4 weeks after 3D TVU
Sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis compared to MRI.
次要结局
- Positive and negative predictive value of 3D TVU in percent (%)(within 17 weeks after 3D TVU)
- Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%)(within 17 weeks after 3D TVU)
- Difference in max. thickness of junction zone, in millimeters (mm)(post ovulatory in any menstruational cycle prior to surgery, within 4 weeks after 3D TVU)
- Prevalence of sub- and infertility, percent (%)(at time of enrollment)
- Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%)(within 17 weeks after 3D TVU)
- Prevalence of miscarriages, in percent (%)(at time of enrollment)
- Prevalence of previous gynecological surgeries, in percent (%)(at time of enrollment)
- Prevalence of previous obstetrical complications, in percent (%)(menarche to time of enrollment)
研究者
Tina Tellum
Medical Doctor
Oslo University Hospital