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

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05342779
• Other study ID #: Soh-Med-22-04-16
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Sohag University
• Contact: kareem d Ahmed, resident
• Phone: 01069492745
• Email: kareem011128[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Varicose Veins

Intervention

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.

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Allegra C, Antignani PL, Bergan JJ, Carpentier PH, Coleridge-Smith P, Cornu-Thénard 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	complication	recurrence and recanalization of the treated vein.; hyperpigmentation; recurrence and recanalization of the treated vein.; ecchymosis, paresthesia, hematoma, erythema and phlebitis.	one year