Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery.
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
Elective colon surgery is considered a clean-contaminated procedure, with a Surgical Site
Infection (SSI) rate not inferior to 10%. For many years the role of Mechanical Bowel
Preparation (MBP) has been universally recognized as an effective measure to reduce colonic
bacterial load and consequently SSI rate, mostly in European Countries. However, in the early
1970s has been demonstrated a further SSI risk reduction in colon surgery if oral
non-absorbable antibiotics were added to MBP and for the next 30 years this became the
standard of care prior to elective colon surgery, especially in the US. Nowadays,
Meta-analyses have demonstrated that MBP does not impact upon postoperative morbidity or
mortality, and as such it should not be prescribed routinely. Conversely, recent evidence has
suggested that there may be a role for combined MBP and oral antibiotics, or oral antibiotics
alone in the prevention of surgical site infection (SSI).
The aim of this trial is to evaluate the efficacy of preoperative oral antibiotics
prophylaxis for preventing surgical site infections in elective colorectal surgery.