Department of General Surgery and Surgical Oncology, Uzsoki Hospital, Budapest, Hungary.
Department of Surgery, University of Pécs Clinical Centre, Pécs, Hungary.
Br J Surg. 2021 Apr 5;108(3):271-276. doi: 10.1093/bjs/znaa131.
There is no consensus regarding the role of mechanical bowel preparation (MBP) and oral antibiotic prophylaxis (OABP) in reducing postoperative complications in colorectal surgery. The aim of this study was to examine the effect of OABP given in addition to MBP in the setting of a prospective randomized trial.
Patients awaiting elective colorectal surgery in four Hungarian colorectal centres were included in this multicentre, prospective, randomized, assessor-blinded study. Patients were randomized to receive MBP with or without OABP (OABP+ and OABP- groups respectively). The primary endpoints were surgical-site infection (SSI) and postoperative ileus. Secondary endpoints were anastomotic leak, mortality, and hospital readmission within 30 days.
Of 839 patients assessed for eligibility between November 2016 and June 2018, 600 were randomized and 529 were analysed. Trial participation was discontinued owing to adverse events in seven patients in the OABP+ group (2.3 per cent). SSI occurred in eight patients (3.2 per cent) in the OABP+ and 27 (9.8 per cent) in the OABP- group (P = 0.001). The incidence of postoperative ileus did not differ between groups. Anastomotic leakage occurred in four patients (1.6 per cent) in the OABP+ and 13 (4.7 per cent) in the OABP- (P = 0.02) group. There were no differences in hospital readmission (12 (4.7 per cent) versus 10 (3.6 per cent); P = 0.25) or mortality (3 (1.2 per cent) versus 4 (1.4 per cent); P = 0.39).
OABP given with MBP reduced the rate of SSI and AL after colorectal surgery with anastomosis, therefore routine use of OABP is recommended.
机械肠道准备（MBP）和口服抗生素预防（OABP）在降低结直肠手术术后并发症方面的作用尚无共识。本研究的目的是在一项前瞻性随机试验中检查 OABP 加 MBP 的效果。
本多中心、前瞻性、随机、评估者盲法研究纳入了 4 家匈牙利结直肠中心的择期结直肠手术患者。患者被随机分为接受 MBP 加或不加 OABP（OABP+和 OABP-组）。主要终点是手术部位感染（SSI）和术后肠梗阻。次要终点是吻合口漏、死亡率和 30 天内再次住院。
2016 年 11 月至 2018 年 6 月，共评估了 839 例符合条件的患者，其中 600 例随机分组，529 例进行了分析。由于 OABP+组的 7 例患者发生不良事件，试验参与被终止（2.3%）。OABP+组发生 SSI 8 例（3.2%），OABP-组发生 SSI 27 例（9.8%）（P=0.001）。两组术后肠梗阻的发生率无差异。吻合口漏发生于 OABP+组 4 例（1.6%），OABP-组 13 例（4.7%）（P=0.02）。两组的再次住院率（12 例[4.7%]与 10 例[3.6%]；P=0.25）或死亡率（3 例[1.2%]与 4 例[1.4%]；P=0.39）无差异。
MBP 加 OABP 降低了结直肠吻合术后 SSI 和 AL 的发生率，因此推荐常规使用 OABP。
