芬兰赫尔辛基大学医院和赫尔辛基大学Laura Koskenvuo课题组取得一项新突破。他们比较了结肠切除术前机械性和口服抗生素肠道准备（MOABP）与非肠道准备（NBP）的效果。 相关论文发表在2019年9月7日出版的《柳叶刀》上。

据悉，在结肠手术中，MOABP与NBP相比，减少了手术部位感染（SSI）和发病率。因此，一些协会推荐结肠切除术患者常规使用MOABP。

在这项多中心、平行、单盲试验中，2016年3月17日至2018年8月20日，芬兰的四家医院共招募了396名需行结肠切除术的成年患者，按1：1随机分组，其中196名进行MOABP，术前一天下午6点之前饮用2L聚乙二醇和1L清液制备肠道，并在晚上7点口服2g新霉素，11点口服2g甲硝唑；208名不进行肠道准备（NBP）。

MOABP组中有13名（7％）患者术后30天内发生SSI，NBP组中有21例（11％），优势为1.65；MOABP组中有7例（4%）患者出现吻合口裂开，NBP组中有8例（4%）；MOABP组中有16例（8%）患者需要再次手术，NBP组中有13例（7%）。术后30天内NBP组有2例患者死亡，而MOABP组无一例死亡。

总而言之，与NBP相比，MOABP并不会降低SSI或结肠手术的总发病率，应慎重考虑在结肠切除术中使用MOABP。

附：英文原文

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

Author: Laura Koskenvuo, Taru Lehtonen, Selja Koskensalo, Suvi Rasilainen, Kai Klintrup, Anu Ehrlich, Tarja Pinta, Tom Scheinin, Ville Sallinen

Issue&Volume: Volume 394 Number 10201

Abstract:

Background

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.

Methods

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.

Findings

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.

Interpretation

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. 

DOI: 10.1016/S0140-6736(19)31269-3

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31269-3/fulltext