The Frequency of Complication and Their Causes After Gonadal Vein Embolization by Coils in Patients With Pelvic Venous Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Postprocedural pain
研究概览
简要总结
Gonadal veins embolization (GVE) with nitinol or platinum coils is widely used in the treatment of PeVD caused by the valvular incompetence of gonadal, parametrial, and uterine veins. Most authors report a high efficacy of this technique in reducing blood flow through the gonadal veins (GV) and relieving symptoms of the disease. In the Society for Vascular Surgery (SVS) and American Venous Forum (AVF) guidelines, GVE is considered the standard of treatment for PeVD with a grade of recommendation 2B, due to the moderate quality of evidence. Moreover, other studies report about wide variability in the GVE outcomes, in terms of pelvic venous pain (PVP) elimination, persistence or intensification of pain after GVE, and coil migrations and protrusions. It is known that 6% to 32% of patients do not achieve significant pain relief after the procedure. The most studies of GVE in the treatment of PeVD are characterized by only a statement of the fact of any complication without investigating the causes of its development. At the same time, it is well known that it is a thorough study of complications that makes it possible to avoid failures in the future, to improve the therapeutic technique, or to abandon its use altogether.
In this study, it is planned to conduct a retrospective analysis of patients' database, who have undergone gonadal veins embolization with nitinol coils.
详细描述
The aim of this study is to describe and study all side-effects and complications following embolization of gonadal veins.
This retrospective cohort study included 150 patients with PeVD who were treated by gonadal veins coil embolisation at the Savelyev University Surgical Clinic of the Pirogov Russian National Research Medical University in the period from 2000 to 2020. Patient informed consent was not required due to the retrospective nature of this study.
Inclusion criteria: the presence of symptoms and signs of PeVD (pelvic venous pain, dyspareunia, discomfort/heaviness in the hypogastric region, vulvar varicosities); reflux in the gonadal, parametrial, uterine veins according to duplex ultrasound and ovarian venography; and gonadal veins coil embolization.
Exclusion criteria: the presence of nutcracker and May-Thurner syndromes, confirmed by multiplanar renal and pelvic venography; open, endoscopic, or hybrid interventions on the gonadal and iliac veins or pelvic organs.
The diagnosis of PeVD was verified by transvaginal and transabdominal DUS, multiplanar computed tomographic venography, ovarian venography.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •the presence of symptoms and signs of PeVD (pelvic venous pain, dyspareunia, discomfort/heaviness in the hypogastric region, vulvar varicosities);
- •reflux in the gonadal, parametrial, uterine veins according to duplex ultrasound and ovarian venography;
- •gonadal veins embolization with coils.
排除标准
- •the presence of nutcracker and May-Thurner syndromes, confirmed by multiplanar renal and pelvic venography;
- •open, endoscopic, or hybrid interventions on the gonadal and iliac veins or pelvic organs.
结局指标
主要结局
Postprocedural pain
时间窗: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins
The visual analogue scale is a line 10 cm long. Each centimeter corresponds to 1 point: 0 points - no pain, 10 points - maximum pain. Higher scores on the scale correspond to poorer results.
Pelvic vein thrombosis
时间窗: 1 and 5 days after the intervention on the pelvic veins
Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins). Pelvic vein thrombosis was detected using duplex ultrasound
Change in the duration of pelvic venous reflux
时间窗: At baseline and 1-12 months after pelvic vein intervention
Pelvic venous reflux was measured using duplex ultrasound. Reflux duration of more than 1 s was considered pathological
Change in the diameter of the pelvic veins
时间窗: At baseline and 1-12 months after pelvic vein intervention
The diameter of the pelvic veins was measured using duplex ultrasound
次要结局
- Other complications after embolisation(1 day, 5 days, 1 and 12 months after coil embolization)
- Allergic reactions(1 day, 5 days, 1 and 12 months after coil embolization)
- Hemorrhagic complications(1 and 5 days after the intervention on the pelvic veins)