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

NCT ID: NCT05342779

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A will undergo stripping of great saphenous vein. .

Group Type: ACTIVE_COMPARATOR

stripping of great saphenous vein

Intervention Type: 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.

Group B will undergo treatment by radiofrequency ablation.

Group Type: ACTIVE_COMPARATOR

stripping of great saphenous vein

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

radiofrequency ablation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Kareem Diaa Eldin AHmed

resident doctor at vascular department sohag university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

kareem d Ahmed, resident

Role: CONTACT

kareem011128@med.sohag.edu.eg

01069492745

osama a abdalrahiem, professor

Role: CONTACT

Facility Contacts

Osama R ElSherif, professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 12514589 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18068562 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18178468 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15570274 (View on PubMed)

Other Identifiers

Soh-Med-22-04-16

Identifier Type: -

Identifier Source: org_study_id