Table 2. Study Outcomes by Treatment Group (Primary and Secondary).
| Study end point | 5-d Regimen (n = 293) | 1-d Regimen (n = 311) | HR (95% CI) | P value |
|---|---|---|---|---|
| Primary outcome | ||||
| Any surgical site infection | 44 (15.0) | 52 (16.7) | 0.93 (0.62-1.40) | .73 |
| Superficial incisional | 13 (4.4) | 12 (3.9) | NR | NR |
| Deep incisional | 3 (1.0) | 8 (2.6) | NR | NR |
| Organ or space | 28 (9.6) | 34 (10.9) | 0.97 (0.59-1.62) | .92 |
| Secondary outcomes | ||||
| Any antibiotic-related complications | 15 (5.1) | 5 (1.6) | 3.24 (1.17-8.98) | .02 |
| Clostridioides difficile–associated colitis | 11 (3.8) | 4 (1.3) | NR | NR |
| Opportunistic fungal infection | 0 | 1 (0.3) | NR | NR |
| Oral candidiasis | 1 (0.3) | 0 | NR | NR |
| Diarrhea (unrelated to C difficile) that required intervention | 3 (1.0) | 0 | NR | NR |
| Any unplanned additional operation | 75 (25.6) | 80 (25.7) | 1.06 (0.77-1.46) | .72 |
| Any oncologic events | 85 (29.0) | 89 (28.6) | 1.02 (0.75-1.39) | .90 |
| Local recurrence | 15 (5.1) | 22 (7.1) | 0.78 (0.40-1.51) | .46 |
| Distant metastases | 69 (23.5) | 79 (25.4) | 0.90 (0.65-1.25) | .53 |
| Other oncologic event | 7 (2.4) | 8 (2.6) | NR | NR |
| All-cause mortality | 37 (12.6) | 40 (12.9) | 1.01 (0.64-1.58) | .98 |
| Death from disease progression | 29 (9.9) | 29 (9.3) | 1.08 (0.64-1.81) | .78 |
Abbreviations: HR, hazard ratio; NR, not reported (these study end points did not meet the threshold set in the Statistical Analysis Plan for the minimum number of events required to conduct a statistical comparison).