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比较双极电凝术与标准大隐静脉剥脱术治疗有症状静脉曲张的随机临床试验。

Randomized clinical trial comparing bipolar coagulating and standard great saphenous stripping for symptomatic varicose veins.

作者信息

Lorenz D, Gäbel W, Redtenbacher M, Weissenhofer W, Minzlaff M, Stengel D

机构信息

DLM Medizin Projectmanagement, Fachbach, Germany.

出版信息

Br J Surg. 2007 Apr;94(4):434-40. doi: 10.1002/bjs.5727.

DOI:10.1002/bjs.5727
PMID:17385181
Abstract

BACKGROUND

Typical side-effects of saphenous stripping for symptomatic varicose veins include painful thigh haematomas, which a new bipolar coagulating electric vein stripper (EVS) may reduce.

METHODS

In a randomized, single-blind trial at three vascular centres, 99 patients were assigned to EVS and 101 to conventional stripping. The primary outcome was postoperative pain at rest and following physical exercise (climbing stairs). Haematomas were quantified by ultrasonography. Further endpoints were duration of postoperative compression, sick leave and quality of life (measured by the Chronic Lower Limb Venous Insufficiency Questionnaire (CIVIQ) and Short Form 36 (SF-36).

RESULTS

Mean resting visual analogue scale for pain 24 h after surgery was 1.6 in the EVS group and 3.3 in the conventional stripping group (mean difference 1.7, 95 per cent confidence interval (c.i.) 1.4 to 1.9, P < 0.001). Mean ratings following exercise were 3.3 and 5.5 (mean difference 2.3, 95 per cent c.i. 2.0 to 2.6, P < 0.001) respectively. No patient in the EVS group had a measurable thigh haematoma, compared with 74 patients after conventional stripping (P < 0.001). The EVS significantly decreased the length of compression therapy and sick leave, and produced superior CIVIQ and SF-36 ratings.

CONCLUSION

The EVS was safe and effective in avoiding painful haematomas following varicose vein surgery.

摘要

背景

有症状的静脉曲张进行大隐静脉剥脱术的典型副作用包括大腿疼痛性血肿,一种新型双极电凝静脉剥脱器(EVS)可能会减少此类情况。

方法

在三个血管中心进行的一项随机单盲试验中,99例患者被分配接受EVS治疗,101例接受传统剥脱术。主要结局指标是静息及体育锻炼(爬楼梯)后的术后疼痛。通过超声对血肿进行量化。其他终点指标包括术后加压时间、病假天数和生活质量(通过慢性下肢静脉功能不全问卷(CIVIQ)和简明健康调查问卷(SF - 36)进行测量)。

结果

EVS组术后24小时静息时疼痛的视觉模拟量表平均评分为1.6,传统剥脱术组为3.3(平均差值1.7,95%置信区间(c.i.)1.4至1.9,P < 0.001)。锻炼后的平均评分分别为3.3和5.5(平均差值2.3,95% c.i. 2.0至2.6,P < 0.001)。EVS组没有患者出现可测量的大腿血肿,而传统剥脱术后有74例患者出现(P < 0.001)。EVS显著缩短了加压治疗时间和病假天数,并产生了更好的CIVIQ和SF - 36评分。

结论

EVS在避免静脉曲张手术后疼痛性血肿方面安全有效。

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