Endpoints | Definitions |
---|---|
Primary composite endpoint | |
Cumulative incidence of deep surgical site infection and/or mortality within 30 days after surgery | Deep SSI will be diagnosed according to the CDC criteria for surgical site infections [37]. Deep SSI includes both deep incisional SSI and organ/space SSI |
Secondary endpoints | |
30 days after surgery | |
Cumulative incidence of superficial SSI | Superficial and deep SSIs will diagnosed according to the CDC criteria for surgical site infections [37] |
Cumulative incidence of deep SSI | |
All-cause mortality | |
Cumulative incidence of bacteremia | Blood cultures positive for microorganisms |
Cumulative incidence of infection with Clostridium difficile | Stool sample positive for C. difficile toxins |
Cumulative incidence of infection with HRE | Clinical cultures positive for ESBL or carbapenemase-producing Enterobacteriaceae or Enterobacteriaceae resistant to quinolones and/or aminoglycosides [38] |
Cumulative incidence of rectal colonization with HRE and colistin resistant species | Rectal swabs positive for HRE or colistin resistant species, measured at baseline and 30 days after surgery |
Cumulative incidence of anastomotic leakage | Clinical and/or radiological evidence of leakage requiring surgical or radiological reintervention |
Cumulative incidence of re-laparotomy | Reoperation in the abdominal region |
In-hospital use of antibiotics | Defined as “days on therapy” |
6 months after surgery | |
All-cause mortality | |
Quality of life | Measured with the RAND-36 questionnaire [39] |
Length of hospital stay | In days, including all readmissions |
Length of ICU stay | In days, including all readmissions |
In-hospital costs |