Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101585411 Publication Model: Electronic Cited Medium: Internet ISSN: 2047-2994 (Electronic) Linking ISSN: 20472994 NLM ISO Abbreviation: Antimicrob Resist Infect Control Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central
    • Subject Terms:
      Colistin/*administration & dosage ; Colorectal Surgery/*adverse effects ; Surgical Wound Infection/*prevention & control ; Tobramycin/*administration & dosage; Administration, Oral ; Aged ; Antibiotic Prophylaxis ; Colistin/pharmacology ; Double-Blind Method ; Female ; Humans ; Incidence ; Male ; Middle Aged ; Netherlands/epidemiology ; Surgical Wound Infection/epidemiology ; Therapeutic Equipoise ; Tobramycin/pharmacology
    • Abstract:
      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.
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    • Contributed Indexing:
      Keywords: Colorectal surgery; Infection control; Preoperative oral antibiotic prophylaxis; Surgical site infection
    • Accession Number:
      VZ8RRZ51VK (Tobramycin)
      Z67X93HJG1 (Colistin)
    • Publication Date:
      Date Created: 20200617 Date Completed: 20210401 Latest Revision: 20240329
    • Publication Date:
      20240329
    • Accession Number:
      PMC7294517
    • Accession Number:
      10.1186/s13756-020-00745-2
    • Accession Number:
      32539786