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CompletedNCT02017106EVLTAPUpdated Jul 26, 2019

Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

An interventional study of Endovenous Laser ablation and concomitant phlebectomies and Endovenous Laser ablation and sequential phlebectomies in Varicose Veins, Endovenous Laser Ablation and Phlebectomies, sponsored by Hull University Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-26.

Sponsored by Hull University Teaching Hospitals NHS Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Varicose Veins
  • Endovenous Laser Ablation
  • Phlebectomies

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Keywords

  • Varicose Veins
03

In context

Varicose Veins

253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.

This study's enrollment of 50 is below the median of 104 across 162 interventional studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

Hull University Teaching Hospitals NHS Trust is the lead sponsor of 93 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging
  • did not give consent to trial participation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Concomitant phlebectomies

    Removal of varicose tributaries during Endovenous laser ablation

    Procedure: Endovenous Laser ablation and concomitant phlebectomies · Procedure: Endovenous Laser ablation and sequential phlebectomies

  • Active comparator
    Sequential Phlebectomies

    Endovenous laser ablation only

    Procedure: Endovenous Laser ablation and concomitant phlebectomies · Procedure: Endovenous Laser ablation and sequential phlebectomies

Interventions

  • ProcedureEndovenous Laser ablation and concomitant phlebectomies
  • ProcedureEndovenous Laser ablation and sequential phlebectomies
06

What researchers measure

Primary outcomes

  1. Disease specific QoL (AVVQ)

    Time frame: 5 years

Secondary outcomes

  1. Number of secondary procedures

    Time frame: 5 years

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Study locations

1 site
  • Hull Royal Infirmary
    Hull, Humberside HU32JZ, United Kingdom
08

References and documents

Publications

  • Carradice D, Mekako AI, Hatfield J, Chetter IC. Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins. Br J Surg. 2009 Apr;96(4):369-75. doi: 10.1002/bjs.6556. PubMed 19283745 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02017106
Lead sponsor
Hull University Teaching Hospitals NHS Trust
Responsible party
Sponsor
First posted
Dec 20, 2013
Start date
Apr 2006
Primary completion
Apr 2009
Completion
Apr 2010
Last update
Jul 26, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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