Evaluation of the Efficacy and Safety of Surgical and Endovascular Interventions on the Pelvic Veins in Pelvic Venous Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in the severity of pelvic pain
研究概览
简要总结
This study includes a retrospective and prospective study will enroll patients with pelvic venous disorders who have undergone pelvic vein surgery and endovascular interventions. Three groups of patients will be formed. The first will include patients who underwent open retroperitoneal resection of the gonadal veins and endoscopic trans- and retroperitoneal resection of the gonadal veins. The second group will include patients who underwent embolization of the gonadal veins with coils, the third - patients who underwent stenting of the common iliac veins, or stenting of the iliac veins in combination with embolization of the gonadic veins with coils. Evaluation of the effectiveness and safety of interventions on the pelvic veins will be carried out by assessing the effect of the intervention on pelvic pain, morphological and functional state of the pelvic veins. The assessment of the safety of interventions on the pelvic veins will be carried out by assessing the severity of post-procedural pain, the frequency of complications of operations on the pelvic veins, and complications of anesthesia. In addition, the duration of pelvic vein interventions will be compared with the length of time the patient is in hospital. Based on the data obtained, an algorithm will be proposed for determining the choice of the method of interventions on the pelvic veins in patients with pelvic venous disorders.
详细描述
This study includes a retrospective and prospective study and will include patients with pelvic venous disorders (ovarian venous insufficiency, compression stenosis of the left or right common iliac vein) who underwent surgical and endovascular interventions on the pelvic veins during 2000-2022. The database of the local system "Interin" of the First City Hospital of Moscow (Russia) will be used, into which all information about patients with pelvic venous diseases during 2000-2021 was entered.
In this study, the pelvic veins included the gonadal, parametric, uterine, common, external and internal iliac veins.
Indications for intervention on the gonadal veins are symptoms and signs of pelvic venous disorder (pelvic pain, dyspareunia, heaviness in the hypogastric region, vulvar varicose veins) in combination with the expansion of the gonadal veins of more than 5 mm and reflux in them for more than 1 s.
The indication for intervention on the left / right common iliac vein is the presence of compression stenosis of these veins of more than 50% in combination with symptoms and signs of pelvic venous disease.
Three groups of patients will be formed. The first will include patients with ovarian venous insufficiency, dilation of the gonadal veins of more than 10 mm and reflux along them for more than 1 s, who underwent open retroperitoneal resection and endoscopic trans- and retroperitoneal resection of the gonadal veins.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •the presence of pelvic venous disorder symptoms and signs (chronic pelvic pain, dyspareunia, discomfort/heaviness in the hypogastrium);
- •reflux in the gonadal, parametrial, uterine veins, according to duplex ultrasound scanning and ovarian venography or multislice computed venography (MSCV);
- •narrowing of the lumen of the left CIV greater than 50% with imaging of collateral veins by the radiological contrast studies
排除标准
- •combined surgery on the veins and pelvic organs; comorbidities with СРР
结局指标
主要结局
Change in the severity of pelvic pain
时间窗: At baseline and 12 months after pelvic vein intervention.
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.
次要结局
- Pelvic vein thrombosis(1 and 5 days after the intervention on the pelvic veins)
- Change in the duration of pelvic venous reflux(At baseline and 12 months after pelvic vein intervention.)
- Postprocedural pain(1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins.)
- Change in the diameter of the pelvic veins(At baseline and 12 months after pelvic vein intervention.)
研究者
Sergey Gavrilov, MD, PhD
Professor
Pirogov Russian National Research Medical University