Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

Study Overview
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Brief Summary
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Varicose veins of the leg often have superficial tributaries, which are often symptomatic and a major reason for coming to the doctor. When treating the main varicose vein inside the leg, some doctors prefer to remove these tributaries while others prefer to leave them. This trial aims to see if it is better to remove these veins at the time of the first laser procedure or better to leave them and only remove them when asked.

Detailed Description
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Endovenous laser therapy (EVLT) for varicose veins is associated with high initial occlusion rates, minimal complications and low recurrence rates at 5 years. Randomized trials and meta-analyses have confirmed the efficacy of EVLT in comparison with surgery and other endovenous techniques. There is also evidence that it may be associated with early quality of life (QoL) benefits compared with surgery. The general efficacy of EVLT has therefore been demonstrated and current research focuses on refinement of the procedure. A fundamental question concerns the management of residual varicosities following truncal laser ablation. One approach is to leave these varicosities to regress untouched, minimizing the procedure time and surgical trauma6. This approach, however, is associated with a significant number of secondary and tertiary interventions (sclerotherapy and/or ambulatory phlebectomy). Another option is to combine in a single procedure ambulatory phlebectomy with initial truncal laser ablation (EVLTAP). The aim of this randomized controlled trial was to assess the advantages of performing ambulatory phlebectomy as a concomitant procedure to truncal laser ablation.

Official Title
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Randomized Clinical Trial of Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

Conditions
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Varicose Veins, Endovenous Laser Ablation, Phlebectomies

Intervention / Treatment
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* Procedure: Endovenous Laser ablation and concomitant phlebectomies
* Procedure: Endovenous Laser ablation and sequential phlebectomies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary, symptomatic, unilateral varicose great saphenous veins (GSV), with isolated saphenofemoral junction (SFJ) incompetence and GSV reflux on venous duplex imaging, perigenicular vein diameter exceeding 4 mm, acceptance by the patient of a local anaesthetic procedure. Exclusion Criteria: saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging did not give consent to trial participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concomitant phlebectomies<br>Removal of varicose tributaries during Endovenous laser ablation | Procedure: Endovenous Laser ablation and concomitant phlebectomies<br> <br> Procedure: Endovenous Laser ablation and sequential phlebectomies<br> <br> |
| Active Comparator: Sequential Phlebectomies<br>Endovenous laser ablation only | Procedure: Endovenous Laser ablation and concomitant phlebectomies<br> <br> Procedure: Endovenous Laser ablation and sequential phlebectomies<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific QoL (AVVQ) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of secondary procedures |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose Veins