Table 2.
Rates and odds of permanent colostomy and local recurrence of cancer among patients, by trial arm
| Outcome | Trial arm; no. (%) of patients | OR* (95%CI) | Intra-class correlation coefficient | |
|---|---|---|---|---|
| Intervention n = 558 | Control n = 457 | |||
| Permanent colostomy | ||||
| Procedure at initial surgery | ||||
| Permanent colostomy | 146 (26.2) | 132 (28.9) | ||
| Hartmann’s resection | 20 (3.6) | 27 (5.9) | ||
| Low anterior resection with ileostomy | 101 (18.1) | 46 (10.1) | ||
| Low anterior resection | 291 (52.2) | 252 (55.1) | ||
| Final procedure— permanent colostomy | 218 (39.1) | 185 (40.5) | 0.97 (0.63–1.48) | 0.029 |
| Local recurrence | ||||
| Definite† | 20 (3.6) | 20 (4.4) | ||
| Probable‡ | 16 (2.9) | 7 (1.5) | ||
| Possible§ | 0 (0.0) | 2 (0.4) | ||
| Any | 36 (6.5) | 29 (6.4) | 1.06 (0.68–1.64) | −0.003 |
Note: CI = confidence interval, OR = odds ratio.
*
Generalized estimating equation (GEE) models considered clustering of data at hospital level.
†
Positive histologic result from pelvic mass.
‡
Pelvic mass with any sign (hydronephrosis, invasion of pelvic structures or bleeding) or symptom (deteriorating sexual, bladder or bowel function; or persistent or worsening lower back, perineal or sciatic pain).
§
Any symptom of probable recurrence, as described above.