Oral neomycin and bacitracin are effective in preventing surgical site infections in elective colorectal surgery: a multicentre, randomized, parallel, single-blinded trial (COLORAL-1)

Alberto Arezzo,Edoardo Forcignanò,Nicola Cillara,Roberto Passera,Roberto Ottonello,Silvia Corcione,Nereo Vettoretto,Francesco Giuseppe De Rosa,Emanuele Botteri,Massimiliano Mistrangelo,Marco Augusto Bonino,Paola Salusso,Valentina Testa,Mario Morino

doi:10.1007/s13304-021-01112-5

Alberto Arezzo, Edoardo Forcignanò + Show 12 more

Open Access

https://doi.org/10.1007/s13304-021-01112-5

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Abstract

Several regimens of oral and intravenous antibiotics (OIVA) have been proposed with contradicting results, and the role of mechanical bowel preparation (MBP) is still controversial. This study aims to assess the effectiveness of oral antibiotic prophylaxis in preventing Surgical Site Infections (SSI) in elective colorectal surgery. In a multicentre trial, we randomized patients undergoing elective colorectal resection surgery, comparing the effectiveness of OIVA versus intravenous antibiotics (IVA) regimens to prevent SSI as the primary outcome (NCT04438655). In addition to intravenous Amoxicillin/Clavulanic, patients in the OIVA group received Oral Neomycin and Bacitracin 24 h before surgery. MBP was administered according to local habits which were not changed for the study. The trial was terminated during the COVID-19 pandemic, as many centers failed to participate as well as the pandemic changed the rules for engaging patients. Two-hundred and four patients were enrolled (100 in the OIVA and 104 in the IVA group); 3 SSIs (3.4%) were registered in the OIVA and 14 (14.4%) in the IVA group (p = 0.010). No difference was observed in terms of anastomotic leak. Multivariable analysis indicated that OIVA reduced the rate of SSI (OR 0.21 / 95% CI 0.06–0.78 / p = 0.019), while BMI is a risk factor of SSI (OR 1.15 / 95% CI 1.01–1.30 p = 0.039). Subgroup analysis indicated that 0/22 patients who underwent OIVA/MBP + vs 13/77 IVA/MBP- experienced an SSI (p = 0.037). The early termination of the study prevents any conclusion regarding the interpretation of the data. Nonetheless, Oral Neomycin/Bacitracin and intravenous beta-lactam/beta-lactamases inhibitors seem to reduce SSI after colorectal resections, although not affecting the anastomotic leak in this trial. The role of MBP requires more investigation.

Highlights

Elective colorectal surgery is considered a clean-contaminated procedure, with a surgical site infection (SSI) rate of about 10% or above [1,2,3]
Arguments against the use of oral antibiotic prophylaxis associated with mechanical intestinal preparation are the heterogeneity of the proposed protocols that did not make clear the results
In addition to an undoubted greater difficulty in organizing the preoperative workflow, there is a resistance from patients to the intake, especially of intestinal preparation

Summary

Introduction

Elective colorectal surgery is considered a clean-contaminated procedure, with a surgical site infection (SSI) rate of about 10% or above [1,2,3]. The role of Mechanical Bowel Preparation (MBP) has been universally recognized as an effective measure to reduce the colorectal bacterial load and SSI rate, mostly in European Countries [4]. In the early 1970s, Nichols et al showed a further SSI risk reduction in colorectal surgery if oral non-absorbable antibiotics were added to MBP [5], and for the 30 years, this was suggested as the standard of care prior to elective colorectal surgery, especially in the US. At least in Italy, the adoption of oral antibiotic prophylaxis to reduce SSIs is still not common, and where it is adopted, it is performed with a variety of schemes

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