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Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02017106
Acronym
EVLTAP
Enrollment
50
Registered
2013-12-20
Start date
2006-04-30
Completion date
2010-04-30
Last updated
2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endovenous Laser Ablation, Phlebectomies, Varicose Veins

Keywords

Varicose Veins

Brief summary

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

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.

Interventions

PROCEDUREEndovenous Laser ablation and concomitant phlebectomies
PROCEDUREEndovenous Laser ablation and sequential phlebectomies

Sponsors

Hull University Teaching Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Disease specific QoL (AVVQ)5 years

Secondary

MeasureTime frame
Number of secondary procedures5 years

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026