Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2010-04-30

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.

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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.

Conditions

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Varicose Veins Endovenous Laser Ablation Phlebectomies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concomitant phlebectomies

Removal of varicose tributaries during Endovenous laser ablation

Group Type EXPERIMENTAL

Endovenous Laser ablation and concomitant phlebectomies

Intervention Type PROCEDURE

Endovenous Laser ablation and sequential phlebectomies

Intervention Type PROCEDURE

Sequential Phlebectomies

Endovenous laser ablation only

Group Type ACTIVE_COMPARATOR

Endovenous Laser ablation and concomitant phlebectomies

Intervention Type PROCEDURE

Endovenous Laser ablation and sequential phlebectomies

Intervention Type PROCEDURE

Interventions

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Endovenous Laser ablation and concomitant phlebectomies

Intervention Type PROCEDURE

Endovenous Laser ablation and sequential phlebectomies

Intervention Type PROCEDURE

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.