Tzovaras G, Delikoukos S, Christodoulides G, Spyridakis M, Mantzos F, Tepetes K, Athanassiou E, Hatzitheofilou C
Department of Surgery, University of Thessaly School of Medicine, University Hospital of Larissa, Larissa, Greece.
Int J Clin Pract. 2007 Feb;61(2):236-9. doi: 10.1111/j.1742-1241.2006.00977.x.
Hernia repair is one of the so-called clean operations. Many surgeons, however, use antibiotics, especially in the mesh repair era, without strong evidence to support this policy. We conducted a single-centre prospective randomised trial with a view to clarify this issue on a scientific basis. From January 2000 all patients undergoing elective inguinal hernia repair using a tension-free polypropylene mesh technique, provided they fulfilled predetermined criteria, were randomised to have a single dose of amoxicillin and clavoulanic acid or placebo in a double-blind manner. The main end point was to detect any difference in infectious complication rates - with specific interest to wound infection rates - between the two groups. Between January 2000 and June 2004, 386 patients entered the study (364 men and 22 women, median age 63 years, range 15-90 years) and were randomised to have antibiotic prophylaxis (group A, n = 193) or placebo (group B, n = 193). The two groups were comparable regarding demographic data. In total, 19 (5%) cases with infectious complications were detected. Fourteen of these were wound infections (3.7%). There were five cases of wound infection in group A and nine in group B (p = 0.4, Fisher's exact test). All wound infections were treated with antibiotics. The wound was opened in some cases. Mesh removal was not required in any of the cases. From the results of this study it does not appear that antibiotic prophylaxis offers any benefits in the elective mesh inguinal hernia repair.
疝修补术是所谓的清洁手术之一。然而，许多外科医生使用抗生素，尤其是在补片修补时代，却没有有力证据支持这一做法。我们开展了一项单中心前瞻性随机试验，旨在从科学角度阐明这一问题。从2000年1月起，所有接受择期腹股沟疝无张力聚丙烯补片修补术的患者，只要符合预定标准，均以双盲方式随机接受单剂量阿莫西林克拉维酸或安慰剂治疗。主要终点是检测两组之间感染并发症发生率的差异——尤其关注伤口感染率。2000年1月至2004年6月，386例患者进入研究（364例男性和22例女性，年龄中位数63岁，范围15 - 90岁），并随机分为接受抗生素预防组（A组，n = 193）或安慰剂组（B组，n = 193）。两组在人口统计学数据方面具有可比性。总共检测到19例（5%）感染并发症病例。其中14例为伤口感染（3.7%）。A组有5例伤口感染，B组有9例（p = 0.4，Fisher精确检验）。所有伤口感染均用抗生素治疗。部分病例切开了伤口。所有病例均无需取出补片。从本研究结果来看，抗生素预防在择期补片腹股沟疝修补术中似乎并无任何益处。
