Radio Frequency Ablation Versus Stripping of Great Saphenous Vein in Management of Primary Varicose Veins , Comparative Study

Varicose veins are one of the most common diseases worldwide it constitutes a progressive disease which during its course it produces complications that usually prompt the patient to seek medical care.

Epidemiological studies of the incidence and prevalence of varicose veins found that the majority of adults would develop it over the course of their lifetime; women were found to be four times likely as men to develop it, the incidence of varicose vein occurrence increases with age.

Varicose veins are defined as tortuous dilated veins after or associated with incompetent valves.

Study Overview

• Status: Not yet recruiting
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: stripping of great saphenous vein

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: kareem d Ahmed, resident; Phone Number: 01069492745; Email: kareem011128@med.sohag.edu.eg
• Study Contact Backup: Name: osama a abdalrahiem, professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Inclusion criteria: -. • Adult patients with primary non complicated varicose veins which match the criteria suitable for the procedure

Exclusion Criteria:

• Patients with tortuous GSV that could not allow passage of the sheath, laser fiber, non-palpable distal pulsation.
• inability to ambulate, patients with previous history of deep venous thrombosis (DVT) and pregnant women were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A will undergo stripping of great saphenous vein. .	Procedure: stripping of great saphenous vein; I will make 2 or 3 small cuts in your leg. The cuts are near the top, middle, and bottom of your damaged vein. One is in your groin. The other will be farther down your leg, either in your calf or ankle. I will then thread a thin, flexible plastic wire into the vein through your groin and guide the wire through the vein toward the other cut farther down your leg. The wire is then tied to the vein and pulled out through the lower cut, which pulls the vein out with it. I will close the cuts with stitches. Patient will wear bandages and compression stockings on leg after the procedure.; Other Names: radiofrequency ablation
Active Comparator: Group B will undergo treatment by radiofrequency ablation.	Procedure: stripping of great saphenous vein; I will make 2 or 3 small cuts in your leg. The cuts are near the top, middle, and bottom of your damaged vein. One is in your groin. The other will be farther down your leg, either in your calf or ankle. I will then thread a thin, flexible plastic wire into the vein through your groin and guide the wire through the vein toward the other cut farther down your leg. The wire is then tied to the vein and pulled out through the lower cut, which pulls the vein out with it. I will close the cuts with stitches. Patient will wear bandages and compression stockings on leg after the procedure.; Other Names: radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	Treatment success was defined as symptomatic improvement as well as decrease in vein diameter,echogenic thickening of vein wall and no flow within the occluded lumen by duplex examination Improvement of symptoms in the treated limb	one year
complication	recurrence and recanalization of the treated vein.; hyperpigmentation; recurrence and recanalization of the treated vein.; ecchymosis, paresthesia, hematoma, erythema and phlebitis.	one year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Allegra C, Antignani PL, Bergan JJ, Carpentier PH, Coleridge-Smith P, Cornu-Thenard A, Eklof B, Partsch H, Rabe E, Uhl JF, Widmer MT; International Union of Phlebology Working Group. The "C" of CEAP: suggested definitions and refinements: an International Union of Phlebology conference of experts. J Vasc Surg. 2003 Jan;37(1):129-31. doi: 10.1067/mva.2003.47. No abstract available.
• Meissner MH, Gloviczki P, Bergan J, Kistner RL, Morrison N, Pannier F, Pappas PJ, Rabe E, Raju S, Villavicencio JL. Primary chronic venous disorders. J Vasc Surg. 2007 Dec;46 Suppl S:54S-67S. doi: 10.1016/j.jvs.2007.08.038.
• Proebstle TM, Vago B, Alm J, Göckeritz O, Lebard C, Pichot O. Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: first clinical experience. J Vasc Surg. 2008 Jan;47(1):151-156. doi: 10.1016/j.jvs.2007.08.056.
• Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, Sessa C, Schuller-Petrovic S. Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up. Eur J Vasc Endovasc Surg. 2005 Jan;29(1):67-73. doi: 10.1016/j.ejvs.2004.09.019.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 17, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: Soh-Med-22-04-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No