Five-year results of a randomized controlled trial comparing high ligation combined with endovenous laser ablation and stripping of the great saphenous vein.

PURPOSE: To report 5-year follow-up data of a randomized study comparing high ligation and stripping (HL + S) with high ligation and endovenous laser ablation (HL + EVLA) of the great saphenous vein (GSV). METHODS: One hundred patients were randomized. After 5 years, patient satisfaction with the overall result, CEAP-C class, VCSS, CIVIQ2 quality of life score, and recurrence rate were assessed (clinical examination and duplex ultrasound). RESULTS: Five-year follow-up rates were 83% HL + S and 68% HL + EVLA. Patient satisfaction with the overall result was rated good or very good by 88% after HL + S and 87% after HL + EVLA. There were significant improvements for both groups in CEAP-C class (HL + S 2.28 vs. 1.19; HL + EVLA 2.3 vs. 1.17), VCSS (HL + S 4.79 vs. 1.81; HL + EVLA 4.13 vs. 1.87), and CIVIQ2 score (HL + S 82 vs. 94; HL + EVLA 75 vs. 93) (p < .001). There was no difference in recurrence rates on clinical examination and duplex ultrasound (HL + S 55% vs. HL + EVLA 40%; p = .217). A reopened or residual incompetent GSV-partial or complete-was found in 24% (HL + S) and 40% (HL + EVLA), respectively (p = .141). CONCLUSION: Varicose vein surgery is followed by favorable clinical results and high patient satisfaction, with no difference between HL + S and HL + EVLA.

High ligation combined with stripping and endovenous laser ablation of the great saphenous vein: early results of a randomized controlled study.

OBJECTIVE: This study compared postoperative patient comfort and the surgical outcome of endovenous laser ablation (EVLA) or stripping of the great saphenous vein, both performed in conjunction with high ligation. METHODS: The study randomized 100 patients with primary trunk varicosities of the great saphenous vein (CEAP clinical class II to IV) to EVLA or stripping. The success of surgery was followed-up by duplex ultrasound imaging at 1, 4, and 16 weeks. Primary end points were the size of the hematoma 1 week after the operation and the preoperative disease-specific Chronic Venous Insufficiency Questionnaire (CIVIQ) quality of life score compared with 4 weeks postoperatively. Secondary end points were postoperative symptoms (pain, use of analgesics, paresthesia at the ankle, residual hematoma), complications, time taken to resume work, the patient's satisfaction with the cosmetic outcome, and the CIVIQ quality of life score at 16 weeks. RESULTS: The groups were well matched at baseline. In all, 95 patients could be followed up in accordance with the protocol. The treatment was successful in all patients. Endovenous laser ablation was associated with an occlusion rate of 100%. Hematomas were significantly smaller after EVLA (median [quartiles]) at 125 (55-180) cm(2) vs stripping 200 (123-269) cm(2) (P = .001). No difference was registered between groups for the CIVIQ quality of life score, with EVLA at -1.25 (-7.5-11.25) vs stripping at 4.38 (-5.94-14.38; P = .34). Several postoperative symptoms favored EVLA, but the only significant differences were seen in the minor side effects of surgery at 1 and 4 weeks and discomfort due to paresthesia at the ankle in the first postoperative week. EVLA was associated with a longer period of time until return to work (median [quartiles]) of 20 (14-25.5) days vs 14 (12.8-25) days (P = .054). CONCLUSION: Endovenous laser ablation combined with high ligation is safe and effective. Postoperative hematomas are significantly smaller than those after stripping. Short-term quality of life is at least as good as that after stripping. The long-term results warrant further investigation.