Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial

Basany, Eloy Espín; Solís-Peña, Alejandro; Pellino, Gianluca; Kreisler, Esther; Fraccalvieri, Doménico; Muinelo-Lorenzo, Manuel; Maseda-Díaz, Olga; García-González, José María; Santamaría-Olabarrieta, M.; Cazador, Antonio Codina; Biondo, Sebastiano

doi:10.1016/s2468-1253(20)30075-3

Cited by 97 publications

(68 citation statements)

References 31 publications

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“…In the experimental arm, OAB therapy consisted of a one-day oral administration of ciprofloxacin and metronidazole. SSIs were the primary outcome, and the number of SSIs was significantly reduced in the OAB arm (5% vs 11%, p = 0.013) [145]. However, this reduction was limited to superficial/deep SSIs, as the number of organ/space SSIs was similar (1.9% vs 2.6%).…”

Section: The Role Of Mbp and Oab Preparations (Tables 2 3)mentioning

confidence: 93%

The gut microbiota and colorectal surgery outcomes: facts or hype? A narrative review

et al. 2021

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Background The gut microbiota (GM) has been proposed as one of the main determinants of colorectal surgery complications and theorized as the “missing factor” that could explain still poorly understood complications. Herein, we investigate this theory and report the current evidence on the role of the GM in colorectal surgery. Methods We first present the findings associating the role of the GM with the physiological response to surgery. Second, the change in GM composition during and after surgery and its association with colorectal surgery complications (ileus, adhesions, surgical-site infections, anastomotic leak, and diversion colitis) are reviewed. Finally, we present the findings linking GM science to the application of the enhanced recovery after surgery (ERAS) protocol, for the use of oral antibiotics with mechanical bowel preparation and for the administration of probiotics/synbiotics. Results According to preclinical and translational evidence, the GM is capable of influencing colorectal surgery outcomes. Clinical evidence supports the application of an ERAS protocol and the preoperative administration of multistrain probiotics/synbiotics. GM manipulation with oral antibiotics with mechanical bowel preparation still has uncertain benefits in right-sided colic resection but is very promising for left-sided colic resection. Conclusions The GM may be a determinant of colorectal surgery outcomes. There is an emerging need to implement translational research on the topic. Future clinical studies should clarify the composition of preoperative and postoperative GM and the impact of the GM on different colorectal surgery complications and should assess the validity of GM-targeted measures in effectively reducing complications for all colorectal surgery locations.

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Section: The Role Of Mbp and Oab Preparations (Tables 2 3)mentioning

confidence: 93%

The gut microbiota and colorectal surgery outcomes: facts or hype? A narrative review

et al. 2021

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“…A similar protective effect of oral antibiotic bowel preparation (OABP) without MBP could be shown in a meta-analysis that tried to point out the importance of OABP only for bowel preparation [14]. Recently, a large randomized controlled trial from Spain promoted the use of OABP without MBP to reduce SSIs in colorectal surgery [15].…”

Section: Introductionmentioning

confidence: 76%

“…Unfortunately, those data only promote OABP but do not show any superior regimen so that colorectal surgeons cannot use those data as a proper guideline. Furthermore, OABP without MBP has to be taken into consideration, as recent evidence by the ORALEV trial exists, that the mechanical preparation maybe does not exert any additional benefits in reducing the postoperative infectious complications [14,15].…”

Section: Discussionmentioning

confidence: 99%

“…In general, different antibiotic regimens are used in accordance with local availability of drugs and possible side effects. Most of the studies report the use of either an aminoglycoside (i.e., neomycine [16][17][18], kanamycine [19], streptomycin [20], gentamicine [21]) or a fluoroquinolone (levofloxacine [1] or ciprofloxacine [15]) plus metronidazole. Additionally, in all present studies, single-shot antibiotics were used preoperatively, mostly consisting of an IV application of a secondgeneration cephalosporine plus metronidazole intravenously.…”

Section: Introductionmentioning

confidence: 99%

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Mechanical plus oral bowel preparation with paromomycin and metronidazole reduces infectious complications in elective colorectal surgery: a matched case-control study

Lübbert

Chaberny

Gockel

et al. 2021

Int J Colorectal Dis

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Purpose Infectious complications are as high as 30% in elective colorectal surgery. In recent years, several studies have discussed the topic of preoperative bowel decontamination prior to colorectal surgery in order to reduce postoperative infectious complications and have found significant effects of oral antibiotic administration with a large variety of drugs used. No study has evaluated the combination of oral paromomycin and metronidazole in this context. Methods We performed a prospective single-center study with a matched-pair retrospective cohort to evaluate postoperative infectious complications (superficial site infections, organ space abscess, anastomotic leakage) in elective colorectal surgery. Patients A total of 120 patients were available for study inclusion; 101 gave informed consent and were included. A total of 92 patients were matched and subsequently analyzed. We could show a reduction in overall infectious complications in the intervention group (15.2% vs 30.8%, p = 0.018; odds ratio 0.333, 95% CI 0.142–0.784) as well as a reduction in superficial surgical site infections (8.7 vs 19.6%, p = 0.041, OR 0.333, 95% CI 0.121–0.917). The frequency of the other infectious complications such as intraabdominal abscesses and anastomotic leakage showed a tendency towards decreased frequencies in the intervention group (OR 0.714, 95% CI 0.235–2.169 and OR 0.571; 95% CI 0.167–1.952, respectively). Finally, the oral antibiotic administration led to an almost significantly reduced length of stay (12.24 days vs 15.25 days; p = 0.057). Conclusions Oral paromomycine and metronidazole with intravenous ertapenem effectively reduce infectious complications in elective colorectal surgery. Trial registration The study was registered at Clinicaltrials.gov (NCT03759886) December 17, 2018

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“…Even though a number of preoperative measures are taken to minimise the risks of postoperative infections and complications, they do not eliminate them completely. Prophylactic antibiotics do confer some protection against infections but cause dysbiosis, and this, along with the trauma and stress that the surgery imposes, allow pathogenic bacteria to undergo bacterial translocation (BT) to distant locations and organs, hence causing infections [ 4 , 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

The Effect of Perioperative Administration of Probiotics on Colorectal Cancer Surgery Outcomes

et al. 2021

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The perioperative care of colorectal cancer (CRC) patients includes antibiotics. Although antibiotics do provide a certain protection against infections, they do not eliminate them completely, and they do carry risks of microbial resistance and disruption of the microbiome. Probiotics can maintain the microbiome’s balance postoperatively by maintaining intestinal mucosal integrity and reducing bacterial translocation (BT). This review aims to assess the role of probiotics in the perioperative management of CRC patients. The outcomes were categorised into: postoperative infectious and non-infectious complications, BT rate analysis, and intestinal permeability assessment. Fifteen randomised controlled trials (RCTs) were included. There was a trend towards lower rates of postoperative infectious and non-infectious complications with probiotics versus placebo. Probiotics reduced BT, maintained intestinal mucosal permeability, and provided a better balance of beneficial to pathogenic microorganisms. Heterogeneity among RCTs was high. Factors that influence the effect of probiotics include the species used, using a combination vs. single species, the duration of administration, and the location of the bowel resection. Although this review provided evidence for how probiotics possibly operate and reported notable evidence that probiotics can lower rates of infections, heterogeneity was observed. In order to corroborate the findings, future RCTs should keep the aforementioned factors constant.

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Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial

Cited by 97 publications

References 31 publications

The gut microbiota and colorectal surgery outcomes: facts or hype? A narrative review

The gut microbiota and colorectal surgery outcomes: facts or hype? A narrative review

Mechanical plus oral bowel preparation with paromomycin and metronidazole reduces infectious complications in elective colorectal surgery: a matched case-control study

The Effect of Perioperative Administration of Probiotics on Colorectal Cancer Surgery Outcomes

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