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Mechanical and oral antibiotic bowel preparation versus no bowel preparation for elective colectomy (MOBILE): a multicentre, randomised, parallel, single-blinded trial

Laura Koskenvuo, Taru Lehtonen, Selja Koskensalo, et al

Lancet epub August 08, 2019 DOI:https://doi.org/10.1016/S0140-6736(19)31269-3

Summary

Background 背景

Decreased surgical site infections (SSIs) and morbidity have been reported with mechanical and oral antibiotic bowel preparation (MOABP) compared with no bowel preparation (NBP) in colonic surgery. Several societies have recommended routine use of MOABP in patients undergoing colon resection on the basis of these data. Our aim was to investigate this recommendation in a prospective randomised context.

与不进行肠道准备(NBP)相比，结肠手术前机械性和口服抗生素肠道准备(MOABP)能够降低手术部位感染(SSIs)及罹患率。基于这些资料，一些学会推荐接受结肠切除术的患者常规使用MOABP。我们旨在通过前瞻随机试验对这一推荐意见进行研究。

Methods 方法学

In this multicentre, parallel, single-blinded trial, patients undergoing colon resection were randomly assigned (1:1) to either MOABP or NBP in four hospitals in Finland, using a web-based randomisation technique. Randomly varying block sizes (four, six, and eight) were used for randomisation, and stratification was done according to centre. The recruiters, treating physicians, operating surgeons, data collectors, and analysts were masked to the allocated treatment. Key exclusion criteria were need for emergency surgery; bowel obstruction; colonoscopy planned during surgery; allergy to polyethylene glycol, neomycin, or metronidazole; and age younger than 18 years or older than 95 years. Study nurses opened numbered opaque envelopes containing the patient allocated group, and instructed the patients according to the allocation group to either prepare the bowel, or not prepare the bowel. Patients allocated to MOABP prepared their bowel by drinking 2 L of polyethylene glycol and 1 L of clear fluid before 6 pm on the day before surgery and took 2 g of neomycin orally at 7 pm and 2 g of metronidazole orally at 11 pm the day before surgery. The primary outcome was SSI within 30 days after surgery, analysed in the modified intention-to-treat population (all patients who were randomly allocated to and underwent elective colon resection with an anastomosis) along with safety analyses. The trial is registered with ClinicalTrials.gov, NCT02652637, and EudraCT, 2015–004559–38, and is closed to new participants.

在这项多中心，平行对照，单盲试验中，在芬兰4所医院接受结肠切除术的患者根据基于网络的随机分组技术，按照1:1的比例分别接受MOABP 或 NBP。分组时采用随机区组大小（4，6和8），并根据中心进行分层。负责患者入选人员，主治医生，手术医生，数据收集人员及分析师对治疗分配隐藏。主要的排除标准包括需要急诊手术；肠梗阻；术中计划行结肠镜；对聚乙二醇、新霉素或甲硝唑过敏；年龄不足18岁或超过95岁。研究护士负责打开不透明信封获取患者分组情况，并根据分组对患者进行指导（肠道准备或不进行肠道准备）。MOABP组患者术前一天6 pm前饮用 2 L 聚乙二醇及 1 L 清水，7 pm口服 2 g 新霉素，11 pm口服 2 g 甲硝唑。主要终点为术后30天内 SSI及安全性分析，采用修订后意向治疗分析（接受随机分组且接受择期结肠切除并有吻合口的所有患者）。试验在 ClinicalTrials.gov (NCT02652637) 及EudraCT (2015–004559–38) 注册。

Findings 结果

Between March 17, 2016, and Aug 20, 2018, 738 patients were assessed for eligibility. Of the 417 patients who were randomised (209 to MOABP and 208 to NBP), 13 in the MOABP group and eight in the NBP were excluded before undergoing colonic resection; therefore, the modified intention-to-treat analysis included 396 patients (196 for MOABP and 200 for NBP). SSI was detected in 13 (7%) of 196 patients randomised to MOABP, and in 21 (11%) of 200 patients randomised to NBP (odds ratio 1·65, 95% CI 0·80–3·40; p=0·17). Anastomotic dehiscence was reported in 7 (4%) of 196 patients in the MOABP group and in 8 (4%) of 200 in the NBP group, and reoperations were necessary in 16 (8%) of 196 compared with 13 (7%) of 200 patients. Two patients died in the NBP group and none in the MOABP group within 30 days.

2016年3月17日至2018年8月20日间，共对738名患者进行筛查。最终417名患者接受随机分组（MOABP组209名，NBP组208名），进行结肠切除前MOABP组13名患者及NBP组8名患者被排除；因此，修订后意向治疗分析共纳入396名患者（MOABP组196名，NBP组200名）。MOABP组196名患者中13名(7%)及NBP组200名患者中21名(11%)发生SSI（比数比 1·65, 95% CI 0·80–3·40; p=0·17）。MOABP组196名患者中7名(4%)及NBP组200名患者中8名(4%)发生吻合口瘘，且分别有 16 名 (8%) 和 13 名 (7%) 患者需要二次手术。30天内NBP组患者2名死亡，MOABP组患者没有死亡。

Interpretation 结论

MOABP does not reduce SSIs or the overall morbidity of colon surgery compared with NBP. We therefore propose that the current recommendations of using MOABP for colectomies to reduce SSIs or morbidity should be reconsidered.

与NBP相比，MOABP不能减少结肠手术后的SSIs或总罹患率。因此，我们建议重新考虑当前有关结肠切除术前使用MOABP以减少SSIs或罹患率的推荐意见。

Funding 资助

Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth's Foundation, and Helsinki University Hospital research funds.

评论[仅代表个人意见]

• 既是一个简单的问题，也是一个简单的答案。但是，为什么我没有想到？
• 即使我想到了，我的实验设计会有什么不同？
• 研究结果或许能够改变指南
• 捷径或许在于，从指南中找到证据级别不高的推荐意见，并进行相关研究