Ultrasound Evaluation of the Prevalence of Pelvic Congestion Syndrome in Patients With Endometriosis
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Incidence of pelvic congestive syndrome in patients with endometriosis
研究概览
简要总结
The pelvic congestion syndrome (PCS) is a complex and multifactorial condition associated with inflammatory and hormonal etiophatogenesis similar to the endometriosis.
Furthermore, both pathologies share same clinical symptoms as chronic pelvic pain and dyspareunia.
Our hypothesis is that PCS prevalence is higher in patients with endometriosis than in those without clinical or ultrasound signs of endometriosis.
详细描述
Patients undergoing routine gynecological examinations are included in the study.
Patients are divided into 2 groups:
- Group A: with endometriosis
- Group B: without clinical or ultrasound signs of endometriosis This is an observational, monocentric, prospective, exploratory study. The aim is to assess PCS incidence, associated symptoms and ultrasound characteristics in patients with endometriosis and to compare those findings to those of patients who do not present clinical or ultrasound signs of endometriosis.
The study also evaluates the correlation between:
- Type of pain symptoms (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) and PCS
- Pain severity (assessed according to VAS scale from 0= no pain to 10= unbearable pain) and PCS
- Symptoms and ongoing medical treatments
- History of pelvic surgery and PCS.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Menopause
- •Actual or previous pregnancy
结局指标
主要结局
Incidence of pelvic congestive syndrome in patients with endometriosis
时间窗: 1 day, first medical examination
Comparison of pelvic congestive syndrome symptoms and ultrasounds characteristics, assessed by standard gynecological examination (bimanual gynecological examination and gynecological ultrasounds), between patients with endometriosis (Group A) and without clinical or ultrasound signs of endometriosis.
次要结局
- Correlation between pain severity and pelvic congestive syndrome(1 day, first medical examination)
- Correlation between symptoms and ongoing medical treatments(1 day, first medical examination)
- Correlation between type of pain and pelvic congestive syndrome(1 day, first medical examination)
- Correlation between history of pelvic surgery and pelvic congestive syndrome(1 day, first medical examination)
研究者
Mohamed Mabrouk
Principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna