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

Venous Insufficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06369207
• Other study ID #: 113454
• Status: Active, not recruiting
• Start date: September 12, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Golestan University of Medical sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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. .

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Venous Insufficiency

Locations

Country	Name	City	State
Iran, Islamic Republic of	Pezhman Kharazm, MD	Gorgan	Golestan

Sponsors (1)

Lead Sponsor	Collaborator
Golestan University of Medical sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of reflux transmission pathways in CVI patients with SFJ incompetency	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	one year
Secondary	Anatomic variations of GSV in CVI patients with SFJ incompetency	Determining the frequency of anatomical variations of the great saphenous vein in patients with chronic venous insufficiency secondary to saphenofemoral reflux	one year
Secondary	Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency	Determining the frequency of reflux in the main trunk of the great saphenous vein in patients with chronic venous insufficiency secondary to saphenofemoral reflux.	one year
Secondary	Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency	Determining the frequency of reflux along accessory saphenous veins in patients with chronic venous insufficiency secondary to saphenofemoral reflux.	one year