Clinical trial NCT05342779: Radio Frequency Ablation Versus Stripping of Great Saphenous Vein in Management of Primary Varicose Veins , Comparative Study
Official title: Radio Frequency Ablation Versus Stripping of Great Saphenous Vein in Management of Primary Varicose Veins , Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: success rate
timeFrame: one year
measure: complication
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
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.
citation: 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.
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. doi: 10.1016/j.ejvs.2004.09.019.