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局部庆大霉素-胶原蛋白对腹会阴切除术后会阴伤口并发症和癌症复发的影响:一项多中心随机对照试验。

Effect of local gentamicin-collagen on perineal wound complications and cancer recurrence after abdominoperineal resection: a multicentre randomized controlled trial.

机构信息

Department of Surgical Science, Uppsala University, Uppsala, Sweden.

出版信息

Colorectal Dis. 2013 Mar;15(3):341-6. doi: 10.1111/j.1463-1318.2012.03196.x.

Abstract

AIM

Perineal wound sepsis is a common problem after abdominoperineal resection of the rectum (APR), with a reported incidence of 10-15% in previously non-irradiated patients, 20-30% in patients given preoperative radiation and 50% among patients submitted to preoperative radiation combined with chemotherapy. The local application of gentamicin-collagen was evaluated to determine whether its use in the perineal wound reduced risk complications and had an effect on cancer recurrence.

METHOD

In this prospective multicentre (seven hospitals) randomized controlled trial, 102 patients undergoing APR due to cancer or benign disease were randomized into two groups including surgery with gentamicin-collagen (GS+, n = 52) or surgery without gentamicin-collagen (GS-, n = 50). Patients were followed at 7, 30 and 90 days and at 1 and 5 years.

RESULTS

There were no statistically significant differences between the two groups regarding perineal wound complications, infectious or non-infectious, or cancer recurrence.

CONCLUSION

There was no statistically significant effect on perineal wound complications or cancer recurrence following the local administration of gentamicin-collagen during APR.

摘要

目的

会阴伤口感染是直肠腹会阴切除术(APR)后常见的问题,未接受放疗的患者报道发生率为 10-15%,术前接受放疗的患者为 20-30%,术前接受放疗联合化疗的患者为 50%。本研究旨在评估局部应用庆大霉素-胶原是否能降低会阴伤口并发症的风险,并对癌症复发产生影响。

方法

这是一项前瞻性多中心(7 家医院)随机对照试验,共纳入 102 例因癌症或良性疾病接受 APR 的患者,随机分为两组,包括使用庆大霉素-胶原(GS+,n=52)的手术组和未使用庆大霉素-胶原(GS-,n=50)的手术组。患者分别在术后 7、30 和 90 天以及术后 1 和 5 年进行随访。

结果

两组患者的会阴伤口并发症(感染性或非感染性)或癌症复发无统计学差异。

结论

在 APR 中局部应用庆大霉素-胶原对会阴伤口并发症或癌症复发无统计学显著影响。

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