Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Screeningb | Enrollmentb | Intervention | Follow-up and postoperative proceduresc | |||||
day | ||||||||
Time pointa | ~ − 2 weeks | ~ − 2 weeks to day − 4 | −3 | −2 | −1 | Day 0 | Day 30 | Month 6 |
Patient recruitment | X | |||||||
Eligibility screening | X | |||||||
Informed consent | X | |||||||
Allocation | X | |||||||
Rectal swab | X | X | ||||||
Intake study medication | X | X | X | |||||
Surgery | X | |||||||
Estimation of compliance | X | X | X | |||||
Patient characteristics | X | X | ||||||
Surgical characteristics | X | |||||||
Primary endpoint Deep SSI and/or mortality | X | |||||||
Secondary endpoints | ||||||||
Superficial SSI | X | |||||||
Anastomotic leakage | X | |||||||
Re-laparotomy | X | |||||||
Bacteremia | X | |||||||
Rectal colonization with HRE or colistin resistant species | X | |||||||
Infection with HRE | X | |||||||
Infection with Clostridium difficile | X | |||||||
In-hospital antibiotic use | X | |||||||
Length of hospital stay | X | |||||||
Length of ICU stay | X | |||||||
All-cause mortality | X | X | ||||||
In-hospital costs | X | |||||||
Quality of life | X | X | ||||||
Adverse events | X | X | X | X | X | X | X | |
Serious adverse events | X | X | X | X | X | X | X | |
SUSARs/SARs | X | X | X | X |