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临床试验/NCT06369207
NCT06369207进行中(未招募)不适用

Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux, Presenting to Vascular Surgery Clinics of Golestan Province From 2022 Till 2023

Golestan University of Medical sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
1
主要终点
Determination of reflux transmission pathways in CVI patients with SFJ incompetency

研究概览

简要总结

Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. .

详细描述

Chronic venous insufficiency is one of the most common medical diseases in adults, which severely affects the quality of life of affected patients. What causes symptoms in this disease is the reflux of blood through incompetent valves located in the lower extremity veins. The most common cause is saphenofemoral valve insufficiency.

Although the pathway of reflux transmission is not the same in all patients, the removal of the greater saphenous vein (GSV) is considered a standard treatment according to the guidelines. This treatment leads to unnecessary destruction of the great saphenous vein and failure to correct the pathology in patients whose reflux exited the GSV along its transmission pathway. According to this issue, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency according to the ultrasonographic exam. This cross-sectional study will be conducted with a descriptive-analytical approach on approximately 50 participants. Before surgery, patients are subjected to ultrasonographic mapping to check the pathway of reflux transmission and their related information is recorded. Other demographic information will also be recorded in the relevant checklist. Finally, the data will be analyzed in SPSS software.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic Venous Insufficiency with a clinical grade of 3 (varicosity) or more.
  • Documentation of saphenofemoral junction insufficiency on Doppler ultrasound performed by a radiologist.
  • Patient consent.

排除标准

  • History of DVT

结局指标

主要结局

Determination of reflux transmission pathways in CVI patients with SFJ incompetency

时间窗: one year

Determining the transmission pathways of reflux in patients with chronic venous insufficiency secondary to saphenofemoral reflux referring to vascular surgery clinics in Golestan province from 2022 to 2023

次要结局

  • Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency(one year)
  • Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency(one year)
  • Anatomic variations of GSV in CVI patients with SFJ incompetency(one year)

研究者

发起方
Golestan University of Medical sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pezhman Kharazm, MD

Vascular Surgeon

Golestan University of Medical sciences

研究点 (1)

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