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择期结肠切除术中机械肠道准备的多中心随机临床试验

Multicentre randomized clinical trial of mechanical bowel preparation in elective colonic resection.

作者信息

Jung B, Påhlman L, Nyström P-O, Nilsson E

机构信息

University of Umeå, Department of Surgery, Visby Hospital, Visby, Sweden.

出版信息

Br J Surg. 2007 Jun;94(6):689-95. doi: 10.1002/bjs.5816.

Abstract

BACKGROUND

Recent studies have suggested that MBP does not lower the risk of postoperative septic complications after elective colorectal surgery. This randomized clinical trial assessed whether preoperative MBP is beneficial in elective colonic surgery.

METHODS

A total of 1505 patients, aged 18-85 years with American Society of Anesthesiologists grades I-III, were randomized to MBP or no MBP before open elective surgery for cancer, adenoma or diverticular disease of the colon. Primary endpoints were cardiovascular, general infectious and surgical-site complications within 30 days, and secondary endpoints were death and reoperations within 30 days.

RESULTS

A total of 1343 patients were evaluated, 686 randomized to MBP and 657 to no MBP. There were no significant differences in overall complications between the two groups: cardiovascular complications occurred in 5.1 and 4.6 per cent respectively, general infectious complications in 7.9 and 6.8 per cent, and surgical-site complications in 15.1 and 16.1 per cent. At least one complication was recorded in 24.5 per cent of patients who had MBP and 23.7 per cent who did not.

CONCLUSION

MBP does not lower the complication rate and can be omitted before elective colonic resection.

REGISTRATION NUMBER

ISRCTN28535118 (http://www.controlled-trials.com).

摘要

背景

近期研究表明,围手术期使用抗生素预防择期结直肠手术后的感染并发症并无益处。本随机临床试验旨在评估术前使用抗生素预防择期结肠手术感染并发症的有效性。

方法

本研究共纳入1505例年龄在18-85岁之间、美国麻醉医师协会(ASA)分级为I-III级的患者,随机分为抗生素预防组(MBP)和非抗生素预防组,接受开放性择期结肠癌、腺瘤或结肠憩室手术。主要观察指标为术后30天内心血管、全身感染和手术部位并发症,次要观察指标为术后30天内的死亡率和再次手术率。

结果

共1343例患者纳入分析,其中686例接受抗生素预防,657例未接受。两组患者总体并发症发生率无显著差异:心血管并发症发生率分别为5.1%和4.6%,全身感染并发症发生率分别为7.9%和6.8%,手术部位感染并发症发生率分别为15.1%和16.1%。抗生素预防组和非抗生素预防组患者至少发生1种并发症的比例分别为24.5%和23.7%。

结论

围手术期使用抗生素预防并不能降低择期结肠切除术后的并发症发生率,术前可不使用。

注册号

ISRCTN28535118(http://www.controlled-trials.com)

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