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

NCT ID: NCT06369207

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2024-09-15

Brief 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. .

Detailed 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.

Conditions

Venous Insufficiency

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Golestan University of Medical sciences

OTHER

Sponsor Role: lead

Responsible Party

Pezhman Kharazm, MD

Vascular Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pezhman Kharazm, MD

Gorgan, Golestan Province, Iran

Countries

Iran

Other Identifiers

113454

Identifier Type: -

Identifier Source: org_study_id