Kalteis Manfred, Berger Irmgard, Messie-Werndl Susanne, Pistrich Renate, Schimetta Wolfgang, Pölz Werner, Hieller Franz
Department of Surgery, St Franziskus Hospital, Grieskirchen, Austria.
J Vasc Surg. 2008 Apr;47(4):822-9; discussion 829. doi: 10.1016/j.jvs.2007.10.060. Epub 2008 Mar 4.
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.
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.
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).
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.
本研究比较了大隐静脉腔内激光消融术(EVLA)或剥脱术联合高位结扎术后患者的舒适度和手术效果。
该研究将100例大隐静脉原发性主干静脉曲张患者(CEAP临床分级II至IV级)随机分为接受EVLA或剥脱术治疗。术后1周、4周和16周通过双功超声成像随访手术成功率。主要终点为术后1周血肿大小以及术前特定疾病的慢性静脉功能不全问卷(CIVIQ)生活质量评分,并与术后4周进行比较。次要终点为术后症状(疼痛、使用镇痛药情况、踝关节感觉异常、残余血肿)、并发症、恢复工作所需时间、患者对美容效果的满意度以及术后16周的CIVIQ生活质量评分。
两组在基线时匹配良好。总共95例患者能够按照方案进行随访。所有患者治疗均成功。腔内激光消融术的闭塞率为100%。EVLA术后血肿明显较小(中位数[四分位数]),为125(55 - 180)cm²,而剥脱术为200(123 - 269)cm²(P = 0.001)。两组间CIVIQ生活质量评分无差异,EVLA为 - 1.25(-7.5 - 11.25),剥脱术为4.38(-5.94 - 14.38;P = 0.34)。多项术后症状显示EVLA更具优势,但仅在术后1周和4周手术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方面存在显著差异。EVLA与恢复工作的时间更长相关(中位数[四分位数]),为20(14 - 25.5)天,而剥脱术为14(12.8 - 25)天(P = 0.054)。
腔内激光消融术联合高位结扎术安全有效。术后血肿明显小于剥脱术后。短期生活质量至少与剥脱术后一样好。长期结果有待进一步研究。