Varicose disease, endovenous laser treatment. Circulatory System Varicose veins of lower extremities
Conditions
Interventions
Patients with an incompetent great saphenous vein will be treated with endolaser ablation. In this treatment a laser fibre is introduced intraluminal and the emitted light energy is absorbed by blood,
Sponsors
Sint-Andriesziekenhuis vzw (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with insufficiency of the great saphenous vein with functional and/or aesthetical inconvenience 2. 1470/1500 nm endovenous laser treatment 3. Aged between 18 - 80 years 4. Male or female
Exclusion criteria
Exclusion criteria: 1. Deep venous insufficiency 2. Cross-dilatation with more than two incompetent side-branches 3. Maximal diameter of the saphenous vein greater than 15 mm 4. Therapeutical anticoagumlation or hypocoagulopathy 5. Hypercoagulopathy/thrombophilia 6. Peripheral arterial occlusive disease: Ankle-Brachial Index (ABI) less than 0.85 or history of claudication or ischaemia 7. Pregnancy 8. Patients younger than 18 years and older than 80 years 9. Bilateral treatment 10. Insufficiency of the small and/or anterior saphenous vein
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion rate of the treated veins at one month and six months post-operatively: A duplex scan is scheduled at one month and six months. We use the Groupe d' Évaluation des Lasers et de l'Échographie Vasculaire (GELEV, part of the "Société Française d'Angéiologie") score to interpret the occlusion rate. This duplex score makes it possible to evaluate the morphological development of the treated veins. For this purpose we used the proximal measured diameter of the treated vein, which is located 2 cm distal to the saphenofemoral junction. This diameter was compared in the various outpatient reviews, and the veins were classified using the GELEV score. Morphological change after treatment: Level 0: no occlusion, refluxing vein, unchanged vein Level 1a: partial occlusion with proximal reflux Level 1b: partial occlusion without reflux Level 2a: complete occlusion with unchanged or larger diameter Level 2b: complete occlusion with diameter reduction greater than 30% Level 3: complete occlusion with diameter reduction greater than 50% Level 4: fibrotic cord, vein not visible | — |
Secondary
| Measure | Time frame |
|---|---|
| Possible side-effects of the treatment: 1. Ecchymosis (measured 5 days post-operatively): we developed a scale in which the post-operative ecchymosis around the ablated vein is measured in square centimetres, and this measured surface is divided by the length of the treated vein. 2. Pain score: visual analogue scale (0 - 10) measured 5th post-operative day and one month post-operatively 3. Intake of analgetics: how many days? how many tablets? 4. Incapacity to work: expressed in days 5. Quality of life score: CIVIQ2 auto-questionaire. The construction and validation of a quality of life questionnaire (CIVIQ), originally designed to analyse changes in quality of life (QoL) caused by venous insufficiency, was used to analyse the two-week post-operative morbidity caused by the treatment. This 20-item questionnaire (CIVIQ2) provides a profile on four QoL dimensions (psychological, pain, physical and social) specific to venous derangement of the lower limb. The CIVIQ2 has been demonstrated to be a valid, reliable, stable and sensitive scale. The quality of life questionnaire had to be completed on the 14th post-operative day and to be returned at the one month post-operative control. 6. Patient satisfaction rate: visual analogue score (0 - 10) | — |
Countries
Belgium
Outcome results
None listed