Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
EVLTAP
Randomized Clinical Trial of Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedJuly 26, 2019
July 1, 2019
3 years
December 15, 2013
July 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease specific QoL (AVVQ)
5 years
Secondary Outcomes (1)
Number of secondary procedures
5 years
Study Arms (2)
Concomitant phlebectomies
EXPERIMENTALRemoval of varicose tributaries during Endovenous laser ablation
Sequential Phlebectomies
ACTIVE COMPARATOREndovenous laser ablation only
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging
- did not give consent to trial participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hull Royal Infirmary
Hull, Humberside, HU32JZ, United Kingdom
Related Publications (1)
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.
PMID: 19283745RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2013
First Posted
December 20, 2013
Study Start
April 1, 2006
Primary Completion
April 1, 2009
Study Completion
April 1, 2010
Last Updated
July 26, 2019
Record last verified: 2019-07