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Randomised clinical trial comparing endovenous laser ablation with cryostripping for varicose veins: two-year results

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33832691
Enrollment
120
Registered
2008-03-31
Start date
2003-06-01
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

Endovenous laser versus cryostripping.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with primary symptomatic varicose veins 2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease 3. Informed written consent 4. Age 19 - 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 ultrasound imaging

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
The following were assessed at 6, 12 and 24 months: 1. Operative time 2. Complications 3. Activity impairment 4. Quality-adjusted life years (QALY) 4. Patient satisfaction

Primary

MeasureTime frame
The following were assessed at 6, 12 and 24 months: 1. Freedom from recurrence 2. Improvement in Venous Clinical Severity Score (VCSS) 3. Improvement in Aberdeen Varicose Vein Severity Score (AVVSS) 4. Improvement in the short form 6D (SF-6D), a single preference based measure of health, representing overall quality of life derived from the 36-item short form 36 (SF-36) questionnaires

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026