Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

Varicose Veins Clinical Trial

— EVLTAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017106
• Other study ID #: EVLTAP
• Status: Completed
• Phase: N/A
• Start date: April 2006
• Est. completion date: April 2010

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endovenous Laser Ablation
• Phlebectomies
• Varicose Veins

Intervention

Procedure:
• Endovenous Laser ablation and concomitant phlebectomies

• Endovenous Laser ablation and sequential phlebectomies

Locations

Country	Name	City	State
United Kingdom	Hull Royal Infirmary	Hull	Humberside

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease specific QoL (AVVQ)		5 years
Secondary	Number of secondary procedures		5 years

External Links

•   Publication Link