NCT02796092已完成不适用
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Group of Research in Minimally Invasive Techniques2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年2月1日最近更新:
适应症
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
- 2
- 主要终点
- Change in Pain Scale
研究概览
简要总结
This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.
详细描述
This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Presence of chronic abdominal or pelvic pain for more than 6 months
- •>6 mm pelvic venous caliber measured by transvaginal US
- •Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US
排除标准
- •Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma
- •Glomerular filtration rate <60 ml/min
- •History of contrast reaction
- •Patients not able to be followed up for at least one year
结局指标
主要结局
Change in Pain Scale
时间窗: 12 months
Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9). VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)
次要结局
- Cost of Treatment(Intraoperative)
- Procedure Radiation Dose (DAP)(Intraoperative)
- Total Intervention Duration(Intraoperative)
- Need for Re-embolization(12 months)
- Improvement of Urinary Urgency(12 months)
- Satisfaction With the Procedure(12 months)
- Fluoroscopy Time(Intraoperative)
- Procedure Radiation Dose (AK)(Intraoperative)
- Complications(12 months)
- Improvement of Dyspareunia(12 months)
- Improvement of Dysmenorrhea(12 months)
- Number of Devices Used(intraoperative)
研究者
研究点 (2)
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