Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369207
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-04-12
Brief Title:
Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency
Sponsor:
Golestan University of Medical sciences
Organization:
Golestan University of Medical sciences
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ablationstripping 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 ablationstripping 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
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 ablationstripping 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None