Flessenkämper I, Hartmann M, Stenger D, Roll S
Center for Vascular Diseases, Helios Klinikum Emil von Behring, Berlin, Germany.
Phlebology. 2013 Feb;28(1):16-23. doi: 10.1258/phleb.2011.011147. Epub 2012 Mar 26.
To compare reflux recurrences at the saphenofemoral junction after endovenous laser ablation (EVLA) with or without high ligation with high ligation and stripping (HL/ST) of the great saphenous vein (GSV) in patients with varicosity of the GSV. Design Multicentre, randomized, three-arm, parallel trial. Material and Methods Patients with varicosity of the GSV were randomized to one of three groups: HL/ST, laser ablation (980 nm) or a combination of laser ablation with high ligation (EVLA/HL). Patients were examined clinically and by ultrasound pre- and postoperatively and after two months. The primary endpoint of this ongoing study is the inguinal venous reflux (IVR) in the proximal section of the GSV after two years. We present data after two months. Secondary endpoints include postoperative ecchymosis, pain or discomfort, saphenous syndrome. Groups were compared by chi-squared test.
A total of 449 patients were randomized; mean age 48 years and 71.2% were women. Postoperative ecchymosis developed among 69.2% in the HL/ST group, in 50.4% of the EVLA group and in 50.3% of the EVLA/HL group (P = 0.0007). Postoperative pain after one day occurred in 32.7% in the HL/ST group. Discomfort occurred after surgery in 37.3% in the EVLA group, and in 50.0% in the EVLA/HL group (P = 0.0069). Early postoperative nervus saphenous syndrome developed in 0.6% in the HL/ST group, in 3.7% in the EVLA group and in 6.1% in the EVLA/HL group (P = 0.0341). After two months, IVR persisted in 38 cases (8.5%) in the laser group, in 10 (2.2%) in the EVLA/HL group and none in the HL/ST group (P = 0.6800).
After two months IVR was more often seen in both EVLA groups compared with the HL/ST group. There were significantly more postoperative ecchymosis in the HL/ST. Postoperative pain occurred significantly more often in the EVLA/HL group. Peri- and postoperative data showed significant differences between the three groups. For definitive results concerning the primary endpoint of IVR the later follow-up has to be waited for.
比较大隐静脉曲张患者在接受大隐静脉高位结扎剥脱术（HL/ST）、单纯静脉腔内激光消融术（EVLA）或激光消融联合高位结扎术（EVLA/HL）后，隐股静脉交界处反流复发情况。设计：多中心、随机、三臂、平行试验。材料与方法：大隐静脉曲张患者被随机分为三组之一：HL/ST组、激光消融组（980nm）或激光消融联合高位结扎组（EVLA/HL）。在术前、术后及术后两个月对患者进行临床检查和超声检查。这项正在进行的研究的主要终点是两年后大隐静脉近端的腹股沟静脉反流（IVR）。我们展示了两个月后的数据。次要终点包括术后瘀斑、疼痛或不适、隐神经综合征。采用卡方检验对各组进行比较。
共449例患者被随机分组；平均年龄48岁，女性占71.2%。HL/ST组术后瘀斑发生率为69.2%，EVLA组为50.4%，EVLA/HL组为50.3%（P = 0.0007）。HL/ST组术后1天疼痛发生率为32.7%。EVLA组术后不适发生率为37.3%，EVLA/HL组为50.0%（P = 0.0069）。HL/ST组术后早期隐神经综合征发生率为0.6%，EVLA组为3.7%，EVLA/HL组为6.1%（P = 0.0341）。两个月后，激光组有38例（8.5%）存在IVR，EVLA/HL组有10例（2.2%），HL/ST组无（P = 0.6800）。
与HL/ST组相比，术后两个月时两个EVLA组中IVR更为常见。HL/ST组术后瘀斑明显更多。EVLA/HL组术后疼痛发生明显更频繁。围手术期和术后数据显示三组之间存在显著差异。关于IVR主要终点的确切结果，还需等待后续随访。
