High ligation combined with stripping and endovenous laser ablation of the great saphenous vein:: Early results of a randomized controlled study
High ligation combined with stripping and endovenous laser ablation of the great saphenous vein:: Early results of a randomized controlled study
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DOI：
10.1016/j.jvs.2007.10.060
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发表时间：
2008-04-01
影响因子：
4.3
通讯作者：
Hieller, Franz
中科院分区：
文献类型：
--
作者：
Kalteis, Manfred;Berger, Irrngard;Hieller, Franz
目的：本研究比较了术后患者的舒适度和手术结果的静脉腔内激光消融术（EVLA）或剥离的大隐静脉，都与highligation.Methods：研究随机100例原发性主干静脉曲张的大隐静脉（CEAP临床II级至IV级）EVLA或剥离。在第1、4和16周通过多普勒超声成像对手术成功进行随访。主要终点为术后1周血肿大小和术前、疾病特异性慢性静脉功能不全问卷（CIVIQ）生活质量评分与术后4周相比。次要终点是术后症状（疼痛，使用止痛药，感觉异常的脚踝，残留血肿），并发症，恢复工作所需的时间，病人的满意度与美容效果，和CIVIQ生活质量评分在16 wweeks.Results：组在基线匹配良好。总共有95名患者可以按照方案进行随访。所有患者的治疗均获得成功。静脉腔内激光消融术的闭塞率为100%。EVLA后血肿（中位数[四分位数]）明显小于剥脱术后200（123-269）cm（2）（p = 0.001）。两组的CIVIQ生活质量评分无差异，EVLA评分为-1.25（-7.5-11.25），剥脱评分为4.38（-5.94-14.38; P = 0.34）。几种术后症状有利于EVLA，但唯一的显著差异是手术1周和4周时的轻微副作用以及术后第一周踝关节感觉异常引起的不适。EVLA与恢复工作时间（中位数[四分位数]）相关，分别为20（14-25.5）天和14（12.8-25）天（P = 0.054）。结论：静脉内激光消融联合高位结扎安全有效。术后血肿明显小于剥脱术后。短期生活质量至少与剥离后一样好。长期结果值得进一步研究。
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.