RCT - Does Treating Incompetent Perforators Reduce Recurrence?

The Whiteley Clinic

Status: Unknown

Conditions: Varicose Veins

Treatments: Procedure: phlebectomies; Procedure: TRansluminal Occlusion of Perforators (TRLOP); Procedure: EVLA

Study type: Interventional

Funder types: Other

Identifiers

NCT01949207

RCT20133

Details and patient eligibility

About

The aim of this randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated incompetent perforating veins.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary varicose veins caused by great saphenous vein reflux
• At least one incompetent perforating vein refluxing into the varicosities
• Over 18 years of age

Exclusion criteria

• Reflux from pelvic vein origin or small saphenous vein
• Previous varicose vein surgery,
• Incompetent perforators remote from the varicosities treated,
• Deep vein incompetence
• Deep vein obstruction or occlusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

EVLA, phlebectomies & Trlop closure of incompetent perforators

Experimental group

Description:

endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.

Treatment:

Procedure: phlebectomies

Procedure: EVLA

Procedure: TRansluminal Occlusion of Perforators (TRLOP)

EVLA & phlebectomies

Experimental group

Description:

endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies.

Treatment:

Procedure: phlebectomies

Procedure: EVLA