Table 1.
Baseline patient, tumour and process-of-care characteristics, by trial arm
| Characteristic | Trial arm; no. (%) of patients* | |
|---|---|---|
| Intervention n = 558 | Control n = 457 | |
| Hospitals, no. (%) | 8 (50.0) | 8 (50.0) |
| Surgeons, no. (%) | 56 (53.3) | 49 (46.7) |
| Patient | ||
| Age, yr, median (IQR) | 69.0 (60.0–77.0) | 68.0 (60.0–76.0) |
| Sex, male | 339 (60.8) | 293 (64.1) |
| Comorbidities | ||
| 0 | 410 (73.5) | 346 (75.7) |
| 1 | 114 (20.4) | 91 (19.9) |
| ≥ 2 | 34 (6.1) | 20 (4.4) |
| Tumour | ||
| Size, cm, median (IQR) | 4.0 (3.0–5.0) | 4.0 (3.0–5.0) |
| TNM stage | ||
| 1 | 134 (24.0) | 121 (26.5) |
| 2 | 128 (22.9) | 121 (26.5) |
| 3 | 205 (36.7) | 125 (27.4) |
| 4 | 59 (10.6) | 53 (11.6) |
| Unable to stage | 32 (5.7) | 37 (8.1) |
| Histologic grade | ||
| Well differentiated | 50 (9.0) | 37 (8.1) |
| Moderately differentiated | 432 (77.4) | 318 (69.6) |
| Poorly differentiated | 32 (5.7) | 50 (10.9) |
| Missing | 44 (7.9) | 52 (11.0) |
| Vascular, lymphatic or neural invasion | 146 (26.2) | 134 (29.3) |
| Distance of tumour from anal verge, cm, median (IQR) | 10.0 (5.0–13.0) | 10.0 (5.0–15.0) |
| Process of care | ||
| No. of lymph nodes examined, median (IQR) | 10 (7.0–14.0) | 10 (6.5–16.0) |
| Positive circumferential radial margin† | 41 (7.3) | 44 (9.6) |
| Preoperative radiation | 87 (15.6) | 43 (9.4) |
| Postoperative radiation | 107 (19.2) | 89 (19.5) |
| Preoperative chemotherapy | 64 (11.5) | 40 (8.8) |
| Postoperative chemotherapy | 201 (36.0) | 159 (34.8) |
Note: IQR = interquartile range, TNM = tumour–nodes–metastasis.
*
Unless stated otherwise.
†
Positive circumferential radial margin = distance ≤ 1mm