Etiology Of Recurrent Varicose Veins After Stripping Or Ablation Of Superficial Venous System

Etiology Of Recurrent Varicose Veins After Stripping Or Ablation Of Superficial

Number of patients and causes and patterns of recurrent varicose veins in the lower limbs in patients with history of varicose veins stripping or ablation of the superficial venous system.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Varicose Vein of Lower Limb (Disorder)
• Intervention / Treatment: Diagnostic test: DUS

Detailed Description

Recurrence of varicose veins following surgery is a common, complex and costly problem in vascular surgery. Despite improvements in preoperative evaluation and methods of treatment, recurrence following varicose vein surgery is reported to occur in between 20 and 80% of cases. Many theories have been put forward concerning the underlying mechanisms and causes. These include poor understanding of the venous anatomy and haemodynamics, inadequate preoperative assessment, inappropriate or incomplete surgery and development of new sites of venous reflux as a consequence of disease progression or neovascularisation. However, it is difficult to evaluate these suggestions since the studies from which they arise vary greatly in their definitions of recurrence, preoperative assessment, initial treatment, classification and method and duration of follow-up.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Mohamed Tarek Mostafa, Resident doctor; Phone Number: 002 01116697331; Email: mtarekmostafa96@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with previous history of intervention for varicose veins

Description

Inclusion Criteria:

• 1) Ages eligible for the study: 18-60. 2) Sexes eligible for the study: All. 3) Patients with previous intervention for varicose veins. 4) Patients with primary or secondary varicosities. 5) Patient's compliance to follow-up.

Exclusion Criteria:

1) Patients with no history of interventions for varicose veins. 2) Patients treated with injection sclerotherapy alone. 3) Pregnant women. 4) Patients with arterial disease in the same limb (ABI <0.8). 5) Patients with post-thrombotic syndrome

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Etiology of recurrence of varicose veins in patients previously treated by stripping and ligation or endovenous ablation.	Track the recurrence of varicose veins after intervention	Five years

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life was assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ)	Five years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Kostas T, Ioannou CV, Touloupakis E, Daskalaki E, Giannoukas AD, Tsetis D, Katsamouris AN. Recurrent varicose veins after surgery: a new appraisal of a common and complex problem in vascular surgery. Eur J Vasc Endovasc Surg. 2004 Mar;27(3):275-82. doi: 10.1016/j.ejvs.2003.12.006.
• Blomgren L, Johansson G, Dahlberg-AKerman A, Noren A, Brundin C, Nordstrom E, Bergqvist D. Recurrent varicose veins: incidence, risk factors and groin anatomy. Eur J Vasc Endovasc Surg. 2004 Mar;27(3):269-74. doi: 10.1016/j.ejvs.2003.12.022.
• Hamdan A. Management of varicose veins and venous insufficiency. JAMA. 2012 Dec 26;308(24):2612-21. doi: 10.1001/jama.2012.111352.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Recurrence; Varicose Veins
• Other Study ID Numbers: Recurrent Varicose Veins

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No