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Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins (EVLTAP)

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ClinicalTrials.gov Identifier: NCT02017106
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : December 23, 2013
Sponsor:
Information provided by (Responsible Party):
Daniel Carradice, University of Hull

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.

Condition or disease Intervention/treatment Phase
Varicose Veins Endovenous Laser Ablation Phlebectomies Procedure: Endovenous Laser ablation and concomitant phlebectomies Procedure: Endovenous Laser ablation and sequential phlebectomies Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
Study Start Date : April 2006
Actual Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Disease specific QoL (AVVQ) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of secondary procedures [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017106


Locations
United Kingdom
Hull Royal Infirmary
Hull, Humberside, United Kingdom, HU32JZ
Sponsors and Collaborators
University of Hull

Publications of Results:
Responsible Party: Daniel Carradice, ACL, University of Hull
ClinicalTrials.gov Identifier: NCT02017106     History of Changes
Other Study ID Numbers: EVLTAP
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013

Keywords provided by Daniel Carradice, University of Hull:
Varicose Veins

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases