Clinical trial NCT06369207: Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Insufficiency
Keywords: venous insufficiency
reflux
ultrasonographic mapping
saphenofemoral junction
Lead sponsor: Golestan University of Medical sciences
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All included participants are visited the day before surgery and venous mapping is performed for the patient by the vascular surgeon. The reflux pathway is marked on the skin and information regarding the anatomic characteristics of the reflux are recorded.

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.

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

Primary outcomes:
measure: Determination of reflux transmission pathways in CVI patients with SFJ incompetency
timeFrame: one year
Secondary outcomes:
measure: Anatomic variations of GSV in CVI patients with SFJ incompetency
timeFrame: one year
measure: Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency
timeFrame: one year
measure: Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency
timeFrame: one year
Other outcomes:
Locations:
city: Gorgan
country: Iran, Islamic Republic of
facility: Pezhman Kharazm, MD
state: Golestan
Study officials:
References: