Table 3.
Primary and secondary outcomes of participants in modified intention-to-treat population. Values are numbers (percentages) unless stated otherwise
| Outcomes | Oral prophylaxis group (n=463) | Placebo group (n=463) | Relative risk (95% CI)* | P value |
|---|---|---|---|---|
| Primary outcome | ||||
| Any surgical site infection within 30 postoperative days | 60 (13.0) | 100 (21.6) | 0.60 (0.45 to 0.80) | 0.001 |
| Secondary outcomes† | ||||
| Superficial incisional infection | 15 (3.2) | 24 (5.2) | 0.56 (0.29 to 1.09) | 0.09 |
| Deep incisional infection | 22 (4.8) | 37 (8.0) | 0.54 (0.31 to 0.92) | 0.03 |
| Organ space infection | 23 (5.0) | 39 (8.4) | 0.53 (0.31 to 0.91) | 0.02 |
| SIRS | 96 (20.7) | 122 (26.4) | 0.79 (0.62 to 0.99) | 0.045 |
| Sepsis or septic shock | 26 (5.6) | 42 (9.1) | 0.62 (0.39 to 0.99) | 0.046 |
| Arrhythmia | 84 (18.1) | 76 (16.4) | 1.11 (0.83 to 1.47) | 0.49 |
| Acute heart failure | 1 (0.2) | 0 (0.0) | NA | 1.00 |
| Myocardial infarction | 0 (0.0) | 1 (0.2) | NA | 1.00 |
| Pneumonia | 13 (2.8) | 6 (1.3) | 2.17 (0.83 to 5. 65) | 0.11 |
| Postoperative mechanical ventilation | 9 (1.9) | 15 (3.2) | 0.60 (0.27 to 1.36) | 0.22 |
| Acute kidney injury | 61 (13.2) | 63 (13.6) | 0.97 (0.70 to 1.34) | 0.85 |
| Clavien-Dindo classification grade: | ||||
| 1 or 2 | 188 (40.6) | 181 (39.1) | 0.98 (0.74 to 1.29) | 0.86 |
| ≥3 | 42 (9.1) | 63 (13.6) | 0.63 (0.41 to 0.97) | 0.03 |
| Anastomotic leakage | 22 (4.8) | 37 (8.0) | 0.59 (0.36 to 0.99) | 0.046 |
| Reoperation | 35 (7.6) | 49 (10.6) | 0.71 (0.47 to 1.08) | 0.11 |
| Surgical or endoscopic drainage | 3 (0.7) | 7 (1.5) | 0.43 (0.11 to 1.65) | 0.20 |
| Mean (SD) time from randomisation to adjuvant chemotherapy initiation (days) | 20 (5) | 22 (6) | NA | 0.47 |
| Unplanned hospital readmission | 30 (6.5) | 30 (6.5) | 1 (0.61 to 1.63) | 1.00 |
| Unplanned admission to ICU | 1 (0.2) | 5 (1.1) | 0.20 (0.02 to 1.71) | 0.14 |
| Median (IQR) duration of hospital stay (days) | 6 (5-10) | 7 (5-11) | NA | 0.48 |
| Median (IQR) hospital-free days at 30 days (days) | 24 (20-25) | 23 (19-25) | NA | 0.48 |
| Death: | ||||
| At 30 days | 2 (0.4) | 5 (1.1) | 0.40 (0.08 to 2.05) | 0.27 |
| At 90 days | 5 (1.1) | 10 (2.2) | 0.50 (0.17 to 1.45) | 0.20 |
CI=confidence interval; ICU=intensive care unit; IQR=interquartile range; NA=not applicable; SIRS=systemic inflammatory response syndrome.
*
Relative risk is for oral prophylaxis group compared with placebo group. Confidence intervals were not adjusted for multiple comparisons of other secondary outcomes; thus these analyses are exploratory and should not be used to infer definitive treatment effects. Supplementary table S3 shows the results of adjusted outcome analyses.
†
All secondary outcomes, except 90 day mortality, were assessed up to 30 days after surgery.