Table 1.
Baseline characteristics and treatment of intention-to-treat population
|
Randomised patients |
Non-randomised patients |
||||
|---|---|---|---|---|---|
| Organ preservation (n=27) | Radical surgery (n=28) | Organ preservation (n=61) | Radical surgery (n=7) | ||
| Age, years | 65 (52–79) | 65 (49–83) | 74 (53–89) | 69 (53–73) | |
| Sex | |||||
| Male | 19 (70%) | 17 (61%) | 39 (64%) | 4 (57%) | |
| Female | 8 (30%) | 11 (39%) | 22 (36%) | 3 (43%) | |
| ASA physical status classification | |||||
| I | 11 (41%) | 13 (47%) | 24 (39%) | 4 (57%) | |
| II | 14 (52%) | 11 (39%) | 23 (38%) | 2 (29%) | |
| III | 2 (7%) | 4 (14%) | 13 (21%) | 0 | |
| Missing | ·· | ·· | 1 (2%) | 1 (4%) | |
| Distance from lower border of tumour to anal verge, mm | 60 (40–80) | 60 (50–70) | 60 (40–70) | 55 (35–75) | |
| Tumour position | |||||
| Anterior | 7 (27%) | 10 (35%) | 8 (15%) | 1 (14%) | |
| Lateral | 14 (54%) | 5 (18%) | 20 (36%) | 3 (43%) | |
| Posterior | 5 (19%) | 12 (43%) | 23 42%) | 3 (43%) | |
| Not known | 0 | 1 (4%) | 4 (7%) | 0 | |
| MRI T stage | |||||
| Tx | 1 (4%) | 2 (7%) | 6 (10%) | 0 | |
| T1 | 10 (37%) | 5 (18%) | 10 (16%) | 0 | |
| T2 | 16 (59%) | 21 (75%) | 45 (74%) | 7 (100%) | |
| Ultrasound stage | |||||
| Tx | 0 | 0 | 1 (2%) | 0 | |
| T1 | 9 (33%) | 10 (36%) | 16 (26%) | 1 (14%) | |
| T2 | 10 (37%) | 9 (32%) | 31 (51%) | 4 (57%) | |
| Not done | 8 (30%) | 9 (32%) | 13 (21%) | 2 (29%) | |
| Sphincter preservation considered feasible | |||||
| Yes | 23 (85%) | 25 (89%) | ·· | ·· | |
| No | 4 (15%) | 3 (11%) | ·· | ·· | |
| Compliance with treatment allocation | 23 (85%) | 25 (89%) | 55 (90%) | 7 (100%) | |
| SCRT commenced | 27 (100%) | 3 (11%) | 60 (98%) | ·· | |
| SCRT completed | 27 (100%) | 3 (11%) | 60 (98%) | ·· | |
| Primary surgery | |||||
| TEM | 23 (85%) | 3 (11%) | 55 (92%) | 0 | |
| Low anterior resection | 3 (11%) | 23 (82%) | 0 | 7 (100%) | |
| Abdominoperineal excision | 0 | 2 (7%) | 0 | 0 | |
| No surgery* | 1 (4%) | 0 | 5 (8%) | 0 | |
| Temporary stoma | 2 (7%) | 20 (71%) | 0 | 5 (71%) | |
| Stoma for complications | 1 (4%) | 3 (11%) | 2 | 1 (14%) | |
| Planned early conversion to TME following organ preservation | 5 (19%) | 2 (7%) | 4 (7%) | ·· | |
| Second surgery (planned early conversion following TEM) | |||||
| Low anterior resection | 3 | 0 | 1 | ·· | |
| Abdominoperineal excision | 1 | 2 | 3 | ·· | |
| Hartmann's | 1 | 0 | 0 | ·· | |
| Temporary stoma | 3 | 0 | 1 | ·· | |
| Overall stoma rate | |||||
| Permanent | 2 (7%) | 4 (14%) | 3 (5%) | 0 | |
| Temporary | 6 (22%) | 23 (82%) | 3 (5%) | 6 (86%) | |
| Organ preservation rate | 19 (70%) | 1 (3%) | 56 (92%) | 0 (0%) | |
ASA=American Society of Anesthesiologists. SCRT=short-course radiotherapy. TEM=transanal endoscopic microsurgery. TME=total mesorectal excision.
*
No TEM done following complete clinical response of the primary tumour.