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Background: Surgical site infections (SSIs) are common complications after colorectal surgery. Oral non-absorbable antibiotic prophylaxis (OAP) can be administered preoperatively to reduce the risk of SSIs. Its efficacy without simultaneous mechanical cleaning is unknown., Methods: The Precaution trial was a double-blind, placebo-controlled randomized clinical trial conducted in six Dutch hospitals. Adult patients who underwent elective colorectal surgery were randomized to receive either a three-day course of preoperative OAP with tobramycin and colistin or placebo. The primary composite endpoint was the incidence of deep SSI or mortality within 30 days after surgery. Secondary endpoints included both infectious and non-infectious complications at 30 days and six months after surgery., Results: The study was prematurely ended due to the loss of clinical equipoise. At that time, 39 patients had been randomized to active OAP and 39 to placebo, which reflected 8.1% of the initially pursued sample size. Nine (11.5%) patients developed the primary outcome, of whom four had been randomized to OAP (4/39; 10.3%) and five to placebo (5/39; 12.8%). This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78). In the per-protocol analysis, the relative risk was 0.64 (95% CI 0.12-3.46)., Conclusions: Observational data emerging during the study provided new evidence for the effectiveness of OAP that changed both the clinical and medical ethical landscape for infection prevention in colorectal surgery. We therefore consider it unethical to continue randomizing patients to placebo. We recommend the implementation of OAP in clinical practice and continuing monitoring of infection rates and antibiotic susceptibilities., Trial Registration: The PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.

To reduce the of risk infection after colorectal surgery, oral antibiotic preparation (OAP) and mechanical bowel preparation (MBP) can be applied. Whether OAP can be used without MBP is unclear. A meta-analysis of observational studies demonstrated comparable effectiveness of OAP with and without MBP regarding SSI risk.

Background: Surgical site infections (SSIs) are common complications after colorectal procedures and remain an important source of morbidity and costs. Preoperative oral antibiotic prophylaxis is a potential infection control strategy, but its effectiveness without simultaneous use of mechanical bowel preparation (MBP) is unclear. In this study, we aimed to determine whether preoperative oral antibiotics reduce the risk of deep SSIs in elective colorectal surgery., Methods: We performed a before-after analysis in a teaching hospital in the Netherlands. Patients who underwent surgery between January 2012 and December 2015 were included. On 1 January 2013, oral antibiotic prophylaxis with tobramycin and colistin was implemented as standard of care prior to colorectal surgery. The year before implementation was used as the control period. The primary outcome was a composite of deep SSI and/or mortality within 30 days after surgery., Results: Of the 1410 patients, 352 underwent colorectal surgery in the control period and 1058 in the period after implementation of the antibiotic prophylaxis. We observed a decrease in incidence of the primary endpoint of 6.2% after prophylaxis implementation. When adjusted for confounders, the risk ratio for development of the primary outcome was 0.58 (95% confidence interval, 0.40-0.79). Other findings included a decreased risk of anastomotic leakage and a reduction in the length of postoperative stay., Conclusions: Preoperative oral antibiotic prophylaxis prior to colorectal surgery is associated with a significant decrease in SSI and/or mortality in a setting without MBP. Preoperative oral antibiotics can therefore be considered without MBP for patients who undergo colorectal surgery., (© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Objective: Surveillance of surgical site infections (SSIs) is important for infection control and is usually performed through retrospective manual chart review. The aim of this study was to develop an algorithm for the surveillance of deep SSIs based on clinical variables to enhance efficiency of surveillance., Design: Retrospective cohort study (2012-2015)., Setting: A Dutch teaching hospital., Participants: We included all consecutive patients who underwent colorectal surgery excluding those with contaminated wounds at the time of surgery. All patients were evaluated for deep SSIs through manual chart review, using the Centers for Disease Control and Prevention (CDC) criteria as the reference standard., Analysis: We used logistic regression modeling to identify predictors that contributed to the estimation of diagnostic probability. Bootstrapping was applied to increase generalizability, followed by assessment of statistical performance and clinical implications., Results: In total, 1,606 patients were included, of whom 129 (8.0%) acquired a deep SSI. The final model included postoperative length of stay, wound class, readmission, reoperation, and 30-day mortality. The model achieved 68.7% specificity and 98.5% sensitivity and an area under the receiver operator characteristic (ROC) curve (AUC) of 0.950 (95% CI, 0.932-0.969). Positive and negative predictive values were 21.5% and 99.8%, respectively. Applying the algorithm resulted in a 63.4% reduction in the number of records requiring full manual review (from 1,606 to 590)., Conclusions: This 5-parameter model identified 98.5% of patients with a deep SSI. The model can be used to develop semiautomatic surveillance of deep SSIs after colorectal surgery, which may further improve efficiency and quality of SSI surveillance.

Background: Colorectal surgery is frequently complicated by surgical site infections (SSIs). The most important consequences of SSIs are prolonged hospitalization, an increased risk of surgical reintervention and an increase in mortality. Perioperative intravenously administered antibiotic prophylaxis is the standard of care to reduce the risk of SSIs. In the last few decades, preoperative orally administered antibiotics have been suggested as additional prophylaxis to further reduce the risk of infection, but are currently not part of routine practice in most hospitals. The objective of this study is to evaluate the efficacy of a preoperative orally administered antibiotic prophylaxis (Pre-OP) in addition to intravenously administered perioperative antibiotic prophylaxis to reduce the incidence of deep SSIs and/or mortality after elective colorectal surgery., Methods/design: The PreCaution trial is designed as a multicenter, double-blind, randomized, placebo-controlled clinical trial that will be carried out in The Netherlands. Adult patients who are scheduled for elective colorectal surgery are eligible to participate. In total, 966 patients will be randomized to receive the study medication. This will either be Pre-OP, a solution that consists of tobramycin and colistin sulphate, or a placebo solution. The study medication will be administered four times daily during the 3 days prior to surgery. Perioperative intravenously administered antibiotic prophylaxis will be administered to all patients in accordance with national infection control guidelines. The primary endpoint of the study is the cumulative incidence of deep SSIs and/or mortality within 30 days after surgery. Secondary endpoints include both infectious and non-infectious complications of colorectal surgery, and will be evaluated 30 days and/or 6 months after surgery., Discussion: To date, conclusive evidence on the added value of preoperative orally administered antibiotic prophylaxis in colorectal surgery is lacking. The PreCaution trial should determine the effects of orally administered antibiotics in preventing infectious complications in elective colorectal surgery., Trial Registration: Netherlands Trial Register, ID: NTR6113 . Registered on 11 October 2016; EudraCT 2015-005736-17.