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

NCT06369207 | Completed

• 1 other identifier: 113454
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. .

Conditions

Venous Insufficiency

Keywords

venous insufficiency; reflux; ultrasonographic mapping; saphenofemoral junction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Anatomic variations of GSV in CVI patients with SFJ incompetency

  one year

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

  one year

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

  one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- History of DVT

Sponsors & Collaborators

• Golestan University of Medical sciences: lead

Study Sites (1)

Pezhman Kharazm, MD

Gorgan, Golestan Province, 4917956808, Iran

Location

MeSH Terms

Conditions

Venous Insufficiency; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: September 12, 2023
• Primary Completion: February 15, 2024
• Study Completion: September 15, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

IR (1)