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

Primary Purpose

Varicose Veins

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
stripping of great saphenous vein
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A will undergo stripping of great saphenous vein. .

Group B will undergo treatment by radiofrequency ablation.

Arm Description

Outcomes

Primary Outcome Measures

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
complication
recurrence and recanalization of the treated vein. hyperpigmentation recurrence and recanalization of the treated vein. ecchymosis, paresthesia, hematoma, erythema and phlebitis.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2022
Last Updated
April 17, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05342779
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A will undergo stripping of great saphenous vein. .
Arm Type
Active Comparator
Arm Title
Group B will undergo treatment by radiofrequency ablation.
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
stripping of great saphenous vein
Other Intervention Name(s)
radiofrequency ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
success rate
Description
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
Time Frame
one year
Title
complication
Description
recurrence and recanalization of the treated vein. hyperpigmentation recurrence and recanalization of the treated vein. ecchymosis, paresthesia, hematoma, erythema and phlebitis.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kareem d Ahmed, resident
Phone
01069492745
Email
kareem011128@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
osama a abdalrahiem, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R ElSherif, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12514589
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.
Results Reference
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PubMed Identifier
18068562
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.
Results Reference
background
PubMed Identifier
18178468
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.
Results Reference
background
PubMed Identifier
15570274
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.
Results Reference
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Radio Frequency Ablation Versus Stripping of Great Saphenous Vein in Management of Primary Varicose Veins , Comparative Study

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