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

Primary Purpose

Varicose Veins, Endovenous Laser Ablation, Phlebectomies

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endovenous Laser ablation and concomitant phlebectomies
Endovenous Laser ablation and sequential phlebectomies
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring Varicose Veins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hull Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concomitant phlebectomies

Sequential Phlebectomies

Arm Description

Removal of varicose tributaries during Endovenous laser ablation

Endovenous laser ablation only

Outcomes

Primary Outcome Measures

Disease specific QoL (AVVQ)

Secondary Outcome Measures

Number of secondary procedures

Full Information

First Posted
December 15, 2013
Last Updated
July 24, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02017106
Brief Title
Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
Acronym
EVLTAP
Official Title
Randomized Clinical Trial of Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Endovenous Laser Ablation, Phlebectomies
Keywords
Varicose Veins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concomitant phlebectomies
Arm Type
Experimental
Arm Description
Removal of varicose tributaries during Endovenous laser ablation
Arm Title
Sequential Phlebectomies
Arm Type
Active Comparator
Arm Description
Endovenous laser ablation only
Intervention Type
Procedure
Intervention Name(s)
Endovenous Laser ablation and concomitant phlebectomies
Intervention Type
Procedure
Intervention Name(s)
Endovenous Laser ablation and sequential phlebectomies
Primary Outcome Measure Information:
Title
Disease specific QoL (AVVQ)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of secondary procedures
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
Humberside
ZIP/Postal Code
HU32JZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19283745
Citation
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.
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Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

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