The objective of the study was to compare laser ablation with stripping (HL/S) with regards to safety and efficacy, quality of life and economy. The inclusion criteria was age 18–80 years, informed consent, varicose veins and great saphenous veins incompetence as defined by duplex, CEAP clinical classification C2–3, previous high ligation and local treatment accepted if great saphenous vein was preserved in its entire length from groin to knee. Bilateral treatment was permitted, provided both limbs were receiving the same treatment during the same operation.
Patients (121) with great saphenous vein insufficiency were randomised using sealed envelopes. Diagnostic was performed with duplex scan. The treatment consisted of high ligation and pin stripping (n=59, 68 legs) or endovascular laser 980 nm, Biolitec (n=62, 69 legs). Division of all saphenous tributaries was done beyond their secondary branches. The procedure included tumescent local anaesthesia, with lidocaine and adrenaline, 0.1%, and compression and absorbant bandage 48 hours, grade 1 stockings for two weeks. Follow-up was conducted at two weeks, four weeks, three, six, 12, and months for safety, efficacy, pain score (1–10 days), time off work and normal activity, economy, VCSS, AVVSS, SF-36 (quality of life), recurrence rate and -pattern. Follow-up at 36 months is also planned.
Two HL/S procedures failed while three great saphenous veins recanalised in the endovascular laser ablation group. The groups experienced similar improvement in quality of life scores and VCSS score. Complications were rare and minor. Postoperative morbidity, improvements in quality of life, venous clinical severity score and costs were similar in the two groups. Twenty-three (33%) and 18 (26%) of the stripping and endovascular laser ablation group respectively developed new varicose veins, a non-significant difference. The distribution of the recurrent varicose veins was not different between the groups; new incompetent femoral perforations being the most frequent finding at follow-up. A total of 11% were re-operated within two years.
The study concluded that expect for slightly increased postoperative pain and bruising in the HL/S group, no differences were found between the two treatment modalities. The treatments were equally safe and efficient in eliminating great saphenous veins reflux, alleviate symptons and signs of varicosities and improve quality of life. The recurrence rate was disappointingly high in both groups, as seen in other studies. Longer term outcomes, particularly with respect to recurrence rates must be investigated in future studies.