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前瞻性随机对照试验:传统静脉切除术与动力静脉切除术对比

Prospective randomized controlled trial: conventional versus powered phlebectomy.

作者信息

Aremu M A, Mahendran B, Butcher W, Khan Z, Colgan M P, Moore D J, Madhavan P, Shanik D G

机构信息

St James's Vascular Institute, St James's Hospital, Dublin 8, Ireland.

出版信息

J Vasc Surg. 2004 Jan;39(1):88-94. doi: 10.1016/j.jvs.2003.09.044.

DOI:10.1016/j.jvs.2003.09.044
PMID:14718823
Abstract

OBJECTIVES

Transilluminated powered phlebectomy (TriVex) is a new surgical technique that uses tumescent dissection, transillumination, and powered phlebectomy. The purpose of this study was to compare TriVex with conventional varicose vein surgery in terms of pain, cosmesis, recurrence, complications, and operating time.

METHODS

One hundred eighty-eight limbs in 141 patients (33 men, 108 women; mean age, 42.5 years) with varicose veins were randomised to conventional (n = 100) or TriVex (n = 88). Exclusion criteria were venous ulceration or deep venous disease. Varicosities were graded with CEAP and clinical assessment (grades 1-3), and were similar in both groups. Randomization was single blinded. Long or short saphenous vein ligation or stripping was performed as indicated with duplex scanning. Operative time was from skin incision to leg bandaging. Phlebectomy was performed with conventional stab avulsions or TriVex. Patients completed assessment forms preoperatively and postoperatively (2, 6, 26, 52 weeks), and this was supplemented with physician clinical evaluation. Pain was assessed with visual analog score.

RESULTS

There was a significant difference in the number of incisions for phlebectomy in the two groups (conventional, n = 29; TriVex, n = 5; P <.0001). TriVex was faster in the grade 3 (extensive) group, but this did not reach statistical significance. There was no difference in mean postoperative pain score over 8 days in the two groups (P =.4624). At 2 weeks there was no significant difference between the groups with regard to bruising (P =.77), cellulitis (P =.33), and numbness (P =.33). At 6 weeks there was no significant difference between the groups with regard to nerve injury (P =.97), residual veins (P =.79), cosmetic score (P =.837), and overall satisfaction (P =.878). At 6 and 12 months, there was no significant difference in cosmesis (P =.955, P =.088, respectively) or recurrence (P =.27, P =.11, respectively).

CONCLUSIONS

TriVex is a safe and effective method for excision of varicosities and compares well, after a learning curve, with conventional surgery in regard to complications and recurrence. It has the advantage of a trend toward reduced operating time in extensive varicosities, and significantly fewer incisions, although there was no perceived difference in cosmesis during follow-up.

摘要

目的

透光动力静脉切除术(TriVex)是一种采用肿胀麻醉剥离、透光和动力静脉切除的新型手术技术。本研究的目的是在疼痛、美观度、复发率、并发症及手术时间方面,将TriVex与传统静脉曲张手术进行比较。

方法

141例(33例男性,108例女性;平均年龄42.5岁)患有静脉曲张的患者的188条肢体被随机分为传统手术组(n = 100)和TriVex组(n = 88)。排除标准为静脉溃疡或深静脉疾病。静脉曲张采用CEAP分级和临床评估(1 - 3级),两组情况相似。随机分组为单盲。根据双功扫描结果进行大隐静脉或小隐静脉结扎或剥脱术。手术时间从皮肤切开至腿部包扎。静脉切除术采用传统的点状剥脱或TriVex方法。患者在术前及术后(2周、6周、26周、52周)完成评估表,并辅以医生的临床评估。疼痛采用视觉模拟评分法进行评估。

结果

两组静脉切除的切口数量有显著差异(传统手术组,n = 29;TriVex组,n = 5;P <.0001)。在3级(广泛)组中,TriVex手术速度更快,但未达到统计学意义。两组术后8天的平均疼痛评分无差异(P =.4624)。在2周时,两组在瘀斑(P =.77)、蜂窝织炎(P =.33)和麻木(P =.33)方面无显著差异。在6周时,两组在神经损伤(P =.97)、残留静脉(P =.79)、美观评分(P =.837)和总体满意度(P =.878)方面无显著差异。在6个月和12个月时,两组在美观度(分别为P =.955、P =.088)或复发率(分别为P =.27、P =.11)方面无显著差异。

结论

TriVex是一种安全有效的静脉曲张切除术方法,在经历学习曲线后,与传统手术相比,在并发症和复发方面表现良好。它具有在广泛静脉曲张中手术时间有缩短趋势以及切口明显减少的优点,尽管在随访期间美观度方面无明显差异。

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