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NCT Number: NCT06369207

Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency

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. .

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Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pezhman Kharazm, MD

Gorgan, Golestan Province, 4917956808, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18.
  • 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.

Exclusion criteria

  • History of DVT

Treatment and study plan

Primary outcomes

  1. Determination of reflux transmission pathways in CVI patients with SFJ incompetency

    Time frame: 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

Secondary outcomes

  1. Anatomic variations of GSV in CVI patients with SFJ incompetency

    Time frame: one year

    Determining the frequency of anatomical variations of the great saphenous vein in patients with chronic venous insufficiency secondary to saphenofemoral reflux

  2. Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency

    Time frame: one year

    Determining the frequency of reflux in the main trunk of the great saphenous vein in patients with chronic venous insufficiency secondary to saphenofemoral reflux.

  3. Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency

    Time frame: one year

    Determining the frequency of reflux along accessory saphenous veins in patients with chronic venous insufficiency secondary to saphenofemoral reflux.

Sponsors and collaborators

Lead sponsor

Golestan University of Medical sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 16, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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