Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

Not Applicable

Completed

• Conditions: Phlebectomies; Varicose Veins; Endovenous Laser Ablation
• Interventions: Procedure: Endovenous Laser ablation and concomitant phlebectomies; Procedure: Endovenous Laser ablation and sequential phlebectomies

• Registration Number: NCT02017106
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-04
• Study Completion: 2010-04
• Study First Submitted: 2013-12-15
• Study First Submitted QC: 2013-12-15
• Study First Posted: 2013-12-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential Phlebectomies	Endovenous Laser ablation and concomitant phlebectomies	Endovenous laser ablation only
Concomitant phlebectomies	Endovenous Laser ablation and concomitant phlebectomies	Removal of varicose tributaries during Endovenous laser ablation
Sequential Phlebectomies	Endovenous Laser ablation and sequential phlebectomies	Endovenous laser ablation only
Concomitant phlebectomies	Endovenous Laser ablation and sequential phlebectomies	Removal of varicose tributaries during Endovenous laser ablation

Primary Outcome Measures

Name	Time	Method
Disease specific QoL (AVVQ)	5 years

Secondary Outcome Measures

Name	Time	Method
Number of secondary procedures	5 years

Trial Locations

Locations (1)

Hull Royal Infirmary; 🇬🇧 Hull, Humberside, United Kingdom