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临床试验/NCT06311669
NCT06311669进行中(未招募)不适用

Comparative Study Between Isolated Iliac Vein Stenting Versus Concomitant Iliac Vein Stenting With Pelvic Vein Embolization in Patients With Pelvic Venous Insufficiency Secondary to Nonthrombotic Iliac Vein Lesions

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
1
主要终点
Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS)

研究概览

简要总结

The aim of the study is to compare between Isolated Iliac vein stenting vs Concomitant Iliac vein stenting with pelvic vein embolization in patients with Pelvic Venous Insufficiency secondary to Nonthrombotic iliac vein lesions

详细描述

  • Type of Study: Prospective randomized 2 arms clinical trial
  • Study Setting: Ain Shams University hospitals
  • Study Period: 6 months
  • Sample Size: 20 patients
  • Study Population Female patients walking in or referred to the out-patient clinic at Ain Shams University Specialized Hospitals or El-Demerdash University Hospitals with symptoms of pelvic venous insufficiency.
  • Inclusion Criteria:
  1. Female Patients
  2. Child-baring period (18-50)
  3. Patients with type 2 Pelvic congestion (defined as venous substitute pathology secondary to stenosis or obstruction in a draining vein according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
  4. Patients with Nonthrombotic iliac vein lesions confirmed by Duplex with Peak Systolic Velocity (PSV) ratio between stenotic and pre stenotic segment > 2.5.
  5. CEAP Classification C 0,1,2

Exclusion Criteria:

  1. Pregnancy
  2. Breast-feeding
  3. Menopause
  4. Patients with type 1 Pelvic congestion (defined as reflux pathology secondary to valvular or parietal venous anomaly without pelvic or supra-pelvic obstruction to venous flow according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
  5. Patients with type 3 Pelvic congestion (defined as local extrinsic cause responsible for pelvic venous anomaly according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
  6. CEAP Classification C 3,4,5
  • Sampling Method Convenient sample
  • Ethical Considerations An informed consent will be taken from every patient prior to having the procedure to document having their approval for both, having the procedure and participating in the study with emphasis that their medical treatment will not be affected by their refusal of participation according to approved standards to ethical committee of Ain Shams University.
  • Study Tools 20 patients will be randomly divided into 2 equal groups (A and B) Written informed consent. Full history taking with pelvic pain assessment (by onset, course, duration, site, character, radiation, aggravating and reliving factors, severity, timing, associated symptoms) and other pelvic symptoms, urinary symptoms or piles assessment guided by The Pelvic Venous Clinical Severity Score (PVCSS) giving the patient a score.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female Patients 2) Child-baring period (18-50) 3) Patients with type 2 Pelvic congestion (defined as venous substitute pathology secondary to stenosis or obstruction in a draining vein according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 4) Patients with Nonthrombotic iliac vein lesions confirmed by Duplex with Peak Systolic Velocity (PSV) ratio between stenotic and pre stenotic segment > 2.
  • CEAP Classification C 0,1,2

排除标准

  • Pregnancy 2) Breast-feeding 3) Menopause 4) Patients with type 1 Pelvic congestion (defined as reflux pathology secondary to valvular or parietal venous anomaly without pelvic or supra-pelvic obstruction to venous flow according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 5) Patients with type 3 Pelvic congestion (defined as local extrinsic cause responsible for pelvic venous anomaly according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 6) CEAP Classification C 3,4,5

研究组 & 干预措施

Isolated iliac vein stenting

Active Comparator

干预措施: iliac vein stenting (Procedure)

Concomitant iliac vein stenting with pelvic vein embolization

Active Comparator

干预措施: iliac vein stenting (Procedure)

Concomitant iliac vein stenting with pelvic vein embolization

Active Comparator

干预措施: pelvic vein embolization (Procedure)

结局指标

主要结局

Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS)

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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