Department of General, Visceral, Thorax and Vascular Surgery, University Hospital Bonn, Bonn, Germany.
Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
The success of elective colorectal surgery is mainly influenced by the surgical procedure and postoperative complications. The most serious complications include anastomotic leakages and surgical site infections (SSI)s, which can lead to prolonged recovery with impaired long-term health. Compared with other abdominal procedures, colorectal resections have an increased risk of adverse events due to the physiological bacterial colonisation of the large bowel. Preoperative bowel preparation is used to remove faeces from the bowel lumen and reduce bacterial colonisation. This bowel preparation can be performed mechanically and/or with oral antibiotics. While mechanical bowel preparation alone is not beneficial, the benefits and harms of combined mechanical and oral antibiotic bowel preparation is still unclear.
To assess the evidence for the use of combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery.
We searched MEDLINE, Embase, CENTRAL and trial registries on 15 December 2021. In addition, we searched reference lists and contacted colorectal surgery organisations.
We included randomised controlled trials (RCTs) of adult participants undergoing elective colorectal surgery comparing combined mechanical and oral antibiotic bowel preparation (MBP+oAB) with either MBP alone, oAB alone, or no bowel preparation (nBP). We excluded studies in which no perioperative intravenous antibiotic prophylaxis was given.
We used standard methodological procedures as recommended by Cochrane. Pooled results were reported as mean difference (MD) or risk ratio (RR) and 95 % confidence intervals (CIs) using the Mantel-Haenszel method. The certainty of the evidence was assessed with GRADE.
We included 21 RCTs analysing 5264 participants who underwent elective colorectal surgery. None of the included studies had a high risk of bias, but two-thirds of the included studies raised some concerns. This was mainly due to the lack of a predefined analysis plan or missing information about the randomisation process. Most included studies investigated both colon and rectal resections due to malignant and benign surgical indications. For MBP as well as oAB, the included studies used different regimens in terms of agent(s), dosage and timing. Data for all predefined outcomes could be extracted from the included studies. However, only four studies reported on side effects of bowel preparation, and none recorded the occurrence of adverse effects such as dehydration, electrolyte imbalances or the need to discontinue the intervention due to side effects. Seventeen trials compared MBP+oAB with sole MBP. The incidence of SSI could be reduced through MBP+oAB by 44% (RR 0.56, 95% CI 0.42 to 0.74; 3917 participants from 16 studies; moderate-certainty evidence) and the risk of anastomotic leakage could be reduced by 40% (RR 0.60, 95% CI 0.36 to 0.99; 2356 participants from 10 studies; moderate-certainty evidence). No difference between the two comparison groups was found with regard to mortality (RR 0.87, 95% CI 0.27 to 2.82; 639 participants from 3 studies; moderate-certainty evidence), the incidence of postoperative ileus (RR 0.89, 95% CI 0.59 to 1.32; 2013 participants from 6 studies, low-certainty of evidence) and length of hospital stay (MD -0.19, 95% CI -1.81 to 1.44; 621 participants from 3 studies; moderate-certainty evidence). Three trials compared MBP+oAB with sole oAB. No difference was demonstrated between the two treatment alternatives in terms of SSI (RR 0.87, 95% CI 0.34 to 2.21; 960 participants from 3 studies; very low-certainty evidence), anastomotic leakage (RR 0.84, 95% CI 0.21 to 3.45; 960 participants from 3 studies; low-certainty evidence), mortality (RR 1.02, 95% CI 0.30 to 3.50; 709 participants from 2 studies; low-certainty evidence), incidence of postoperative ileus (RR 1.25, 95% CI 0.68 to 2.33; 709 participants from 2 studies; low-certainty evidence) or length of hospital stay (MD 0.1 respectively 0.2, 95% CI -0.68 to 1.08; data from 2 studies; moderate-certainty evidence). One trial (396 participants) compared MBP+oAB versus nBP. The evidence is uncertain about the effect of MBP+oAB on the incidence of SSI as well as mortality (RR 0.63, 95% CI 0.33 to 1.23 respectively RR 0.20, 95% CI 0.01 to 4.22; low-certainty evidence), while no effect on the risk of anastomotic leakages (RR 0.89, 95% CI 0.33 to 2.42; low-certainty evidence), the incidence of postoperative ileus (RR 1.18, 95% CI 0.77 to 1.81; low-certainty evidence) or the length of hospital stay (MD 0.1, 95% CI -0.8 to 1; low-certainty evidence) could be demonstrated.
AUTHORS' CONCLUSIONS: Based on moderate-certainty evidence, our results suggest that MBP+oAB is probably more effective than MBP alone in preventing postoperative complications. In particular, with respect to our primary outcomes, SSI and anastomotic leakage, a lower incidence was demonstrated using MBP+oAB. Whether oAB alone is actually equivalent to MBP+oAB, or leads to a reduction or increase in the risk of postoperative complications, cannot be clarified in light of the low- to very low-certainty evidence. Similarly, it remains unclear whether omitting preoperative bowel preparation leads to an increase in the risk of postoperative complications due to limited evidence. Additional RCTs, particularly on the comparisons of MBP+oAB versus oAB alone or nBP, are needed to assess the impact of oAB alone or nBP compared with MBP+oAB on postoperative complications and to improve confidence in the estimated effect. In addition, RCTs focusing on subgroups (e.g. in relation to type and location of colon resections) or reporting side effects of the intervention are needed to determine the most effective approach of preoperative bowel preparation.
择期结直肠手术的成功主要受手术过程和术后并发症的影响。最严重的并发症包括吻合口漏和手术部位感染(SSI),这可能导致恢复时间延长,长期健康状况受损。与其他腹部手术相比,结直肠切除术由于大肠的生理性细菌定植而增加了发生不良事件的风险。术前肠道准备用于从肠道管腔中清除粪便并减少细菌定植。这种肠道准备可以通过机械和/或口服抗生素来完成。虽然单独进行机械肠道准备没有益处,但联合机械和口服抗生素肠道准备的益处和危害仍不清楚。
评估联合机械和口服抗生素肠道准备在预防择期结直肠手术并发症中的作用。
我们于 2021 年 12 月 15 日在 MEDLINE、Embase、CENTRAL 和试验注册中心进行了检索。此外,我们还检索了参考文献列表并联系了结直肠手术组织。
我们纳入了比较联合机械和口服抗生素肠道准备(MBP+oAB)与单独 MBP、单独 oAB 或无肠道准备(nBP)的成年参与者接受择期结直肠手术的随机对照试验(RCT)。我们排除了未给予围手术期静脉内抗生素预防的研究。
我们使用 Cochrane 推荐的标准方法学程序。使用 Mantel-Haenszel 方法报告汇总结果为均数差(MD)或风险比(RR)和 95%置信区间(CI)。使用 GRADE 评估证据的确定性。
我们纳入了 21 项 RCT,分析了 5264 名接受择期结直肠手术的参与者。纳入的研究均无高偏倚风险,但三分之二的研究存在一些担忧。这主要是由于缺乏预设的分析计划或关于随机化过程的信息缺失。纳入的大多数研究因恶性和良性手术指征而同时调查了结肠和直肠切除术。对于 MBP 和 oAB,纳入的研究在药物、剂量和时间方面使用了不同的方案。可以从纳入的研究中提取所有预设结局的数据。然而,只有四项研究报告了肠道准备的副作用,并且没有一项研究记录了不良反应,如脱水、电解质失衡或因不良反应而需要停止干预。17 项试验比较了 MBP+oAB 与单独 MBP。MBP+oAB 可使 SSI 的发生率降低 44%(RR 0.56,95%CI 0.42 至 0.74;来自 16 项研究的 3917 名参与者;中等确定性证据),吻合口漏的风险降低 40%(RR 0.60,95%CI 0.36 至 0.99;来自 10 项研究的 2356 名参与者;中等确定性证据)。两组之间在死亡率(RR 0.87,95%CI 0.27 至 2.82;来自 3 项研究的 639 名参与者;中等确定性证据)、术后肠梗阻(RR 0.89,95%CI 0.59 至 1.32;来自 6 项研究的 2013 名参与者,低确定性证据)和住院时间(MD-0.19,95%CI-1.81 至 1.44;来自 3 项研究的 621 名参与者;中等确定性证据)方面无差异。三项试验比较了 MBP+oAB 与单独 oAB。两种治疗方案在 SSI(RR 0.87,95%CI 0.34 至 2.21;来自 3 项研究的 960 名参与者;非常低确定性证据)、吻合口漏(RR 0.84,95%CI 0.21 至 3.45;来自 3 项研究的 960 名参与者;低确定性证据)、死亡率(RR 1.02,95%CI 0.30 至 3.50;来自 2 项研究的 709 名参与者;低确定性证据)、术后肠梗阻(RR 1.25,95%CI 0.68 至 2.33;来自 2 项研究的 709 名参与者;低确定性证据)或住院时间(MD 0.1,0.2,95%CI-0.68 至 1.08;来自 2 项研究的中等确定性证据)方面无差异。一项试验(396 名参与者)比较了 MBP+oAB 与 nBP。MBP+oAB 对 SSI 和死亡率(RR 0.63,95%CI 0.33 至 1.23 分别 RR 0.20,95%CI 0.01 至 4.22;低确定性证据)的效果以及吻合口漏(RR 0.89,95%CI 0.33 至 2.42;低确定性证据)、术后肠梗阻(RR 1.18,95%CI 0.77 至 1.81;低确定性证据)或住院时间(MD 0.1,95%CI-0.8 至 1;低确定性证据)的风险无影响,证据不确定。
基于中等确定性证据,我们的结果表明,与单独使用 MBP 相比,MBP+oAB 可能更有效地预防术后并发症。特别是,就我们的主要结局 SSI 和吻合口漏而言,使用 MBP+oAB 可降低发生率。是否单独使用 oAB 实际上等同于 MBP+oAB,或者导致术后并发症的风险降低或增加,由于低至非常低确定性证据,尚无法澄清。同样,由于证据有限,目前尚不清楚省略术前肠道准备是否会因术后并发症风险增加而导致。需要更多的 RCT,特别是关于 MBP+oAB 与 oAB 单独或 nBP 的比较,以评估 oAB 单独或 nBP 与 MBP+oAB 相比对术后并发症的影响,并提高对估计效果的信心。此外,需要 RCT 重点关注亚组(例如与结直肠切除术的类型和位置有关)或报告干预的副作用,以确定术前肠道准备的最佳方法。