Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pelvic congestion pain relief
研究概览
简要总结
Summary:
Main Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in the University hospital of Brest.
The Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey.
详细描述
A retrospective, non-invasive monocentric study of our Hospital 10-year registry (including data on MRI angiography and Vascular Doppler Ultrasound) of patients who have already undergone coil embolization of pelvic gonadal vein in treatment of pelvic congestion syndrome. These patients will be contacted by phone to participate in the study. An information letter will be handed out and the study protocol will be explained to the patients. After obtaining their written consent, they will be asked to fill out the study's validated questionnaire at home and return it to us through pre-paid regular mail. A face to face interview with the patient will be scheduled to assess the correlation between patient's clinical symptoms and survey results. There will be no change in patient's routine follow-up care.
All physician investigators of the study are experts in their field of medicine (e.g. interventional MRI angiography, vascular disease).
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler ultrasound and vascular dynamic MRI
- •Failed medical treatment.
- •> 18 years < 60 years old
排除标准
- •< 18 years old
- •Under legal guardian
- •Asymptomatic pelvic congestion syndrome
- •Psychiatric disorder
- •Endometriosis.
- •Chronic pelvic disease
- •Pregnancy
- •Neoplasia
- •Acute intermittent porphyria
结局指标
主要结局
Pelvic congestion pain relief
时间窗: pre-embolization and 1 month post-gonadal vein embolization
To evaluate (to measure) pain relief using visual analogous scale before and after gonadal vein embolization for pelvic congestion syndrome. A high score means a worse outcome.
次要结局
- evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey(pre-embolization and 1 month post-gonadal vein embolization)
- evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey(pre-embolization and 1 month post-gonadal vein embolization)