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Table 2 Intention-to-treat analysis of OAP on the risk on primary and secondary outcomes

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

 OAPPlacebo 
n/N (%)RR (95% CI)
Deep SSI and/or mortality4/39 (10.3)5/39 (12.8)0.80 (0.23–2.78)
 Deep SSI4/39 (10.3)5/39 (12.8)0.80 (0.23–2.78)
 30-day mortality0/39 (0.0)0/39 (0.0)N/A
Superficial SSI1/39 (2.6)1/39 (2.6)1.00 (0.06–15.40)
Anastomotic leakage1/39 (2.6)2/39 (5.2)0.50 (0.05–5.29)
Re-operation3/39 (7.9)2/39 (5.3)1.50 (0.27–8.49)
Bacteremia0/39 (0.0)0/39 (0.0)N/A
Infection with HRE0/39 (0.0)0/39 (0.0)N/A
Infection with Clostridium difficile0/39 (0.0)0/39 (0.0)N/A
6-month mortality0/39 (0.0)0/39 (0.0)N/A
 Median (IQR)P value
In-hospital use of antibiotics, DOTa0.0 (0.0–0.0)0.0 (0.0–4.0)1.000
Length of stay, daysb7.0 (5.0–13.0)6.0 (5.0–12.0)0.497
Length of ICU stay, daysb4.0 c0N/A
 Median delta (IQR)Pvalue
Quality of lifed
 Physical functioning−5.0 (−15.0–5.0)−10.0 (−20.0–5.0)0.124
 Social role functioning0.0 (0.0–12.5)−12.5 (−25.0–0.0)0.007
 Physical role functioning0.0 (0.0–25.0)−12.5 (−93.7–0.0)0.007
 Emotional role functioning0.0 (0.0–0.0)0.0 (−25.0–0.0)0.237
 Mental health4.0 (−1.0–13.0)0.0 (−7.0–8.0)0.072
 Vitality5.0 (−5.0–10.0)−10.0 (−20.0–0.0)0.002
 Pain0.0(−10.2–10.7)−11.2 (−23.0–6.1)0.002
 General health perception7.5 (0.0–15.0)−5.0 (− 15.0–3.75)0.014
 Change in health0.0 (0.0–50.0)0.0 (−25.0–0.0)0.092
  1. Length of (ICU) stay, quality of life and 6-month mortality were assessed 6 months after surgery, all other outcomes were evaluated 30 days after surgery. DOT, days on therapy; HRE, highly resistant Enterobacteriaceae; ICU, intensive care unit; IQR, interquartile range; N/A, not available; OAP, oral antibiotic prophylaxis; RR, risk ratio; sd, standard deviation; SSI, surgical site infections
  2. a9 patients in the OAP arm and 10 patients in the placebo arm were treated with antibiotics
  3. bIncluding all readmissions within 6 months
  4. cOnly 1 patient was admitted to the ICU
  5. dDelta was calculated by subtracting baseline scores from scores at 6-month follow-up. Negative delta’s reflect worse perception of quality of life on compared to baseline. Number of completed follow-up questionnaires: 27 (69.2%) OAP, 32 (82.1%) placebo