Prevention of severe infectious complications after colorectal surgery using preoperative orally administered antibiotic prophylaxis (PreCaution): study protocol for a randomized controlled trial

Table 3 Study flow

	Study period
	Screening^b	Enrollment^b	Intervention			Follow-up and postoperative procedures^c
	Screening^b	Enrollment^b	day			Follow-up and postoperative procedures^c
Time point^a	~ − 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

HRE highly resistant Enterobacteriaceae, ICU intensive care unit, SAR serious adverse reaction, SSI surgical site infection, SUSAR serious unexpected adverse reaction
^aThe day of surgery is referred to as day 0. The exact time points of the first and second preoperative visits to the outpatient clinic will depend on the local schedules and procedures
^bScreening and enrollment are performed during visits to the outpatient clinic. These visits are not study-specific and are planned according to the local logistics
^cThe postoperative data collection is performed by assessment of the patient registers. A phone call will be made at around day 30 and month 6 to assess the status of the patient and to remind the patient to perform the rectal swab (day 30) and fill in the questionnaire (month 6)

ISSN: 1745-6215