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Randomised clinical trial comparing endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction, with a two-year follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60300873
Enrollment
43
Registered
2008-03-31
Start date
2003-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose veins Circulatory System Varicose veins

Interventions

Forty-three symptomatic patients with bilateral varicose veins were studied in which one side was randomly assigned to receive endovenous laser without saphenofemoral junction (SFJ) ligation, whereas

Sponsors

The Mesos Medical Centre (Mesos Medisch Centrum) (The Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with primary symptomatic bilateral varicose veins 2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease 3. Informed written consent 4. Aged 20 - 75 years 5. Great saphenous vein (GSV) incompetence from the groin to below the knee, defined as retrograde flow lasting longer than 0.5 seconds on duplex scanning

Exclusion criteria

Exclusion criteria: 1. Previous venous surgery 2. History of deep vein thrombosis (DVT) 3. C3-6 CEAP venous disease 4. Deep vein relux 5. Reflux in below knee perforator veins

Design outcomes

Primary

MeasureTime frame
Freedom from recurrent varicose veins in the groin, as confirmed by duplex ultrasound, two years after treatment.

Secondary

MeasureTime frame
The following were assessed at 6, 12 and 24 months: 1. Abolition of reflux in the GSV 2. Venous Clinical Severity Score (VCSS) 3. Freedom from overall recurrent varicose veins 4. Procedural complications, including pain, bruising, saphenous nerve paraesthesia, tightness, superficial thrombophlebitis, skin burns, thrombotic events, and wounds

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026