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

NCT05342779 | Unknown

• 1 other identifier: Soh-Med-22-04-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group A will undergo stripping of great saphenous vein. .

ACTIVE COMPARATOR

Procedure: stripping of great saphenous vein

Group B will undergo treatment by radiofrequency ablation.

ACTIVE COMPARATOR

Procedure: stripping of great saphenous vein

Interventions

stripping of great saphenous vein PROCEDURE

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.

Also known as: radiofrequency ablation

Group A will undergo stripping of great saphenous vein. .; Group B will undergo treatment by radiofrequency ablation.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 12514589 BACKGROUND

• 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.

  PMID: 18068562 BACKGROUND

• Proebstle TM, Vago B, Alm J, Gockeritz 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.

  PMID: 18178468 BACKGROUND

• 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.

  PMID: 15570274 BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

kareem d Ahmed, resident

CONTACT

01069492745; kareem011128@med.sohag.edu.eg

osama a abdalrahiem, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at vascular department sohag university hospital

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 25, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

EG (1)