Table 1.
Phase III randomized controlled trials showing oncological outcomes
| Study and design |
Recurrence
lap vs open |
Survival
lap vs open |
Tumor location (cm from AV) |
Patient enrollment (n) |
LN harvested (n) lap vs open | CRM positivity lap vs open | |||
| DR | LR | DFS | OS | Open | Lap | ||||
| Liang et al[17] Single center | N/A | N/A | N/A | 76% vs 82.8% P = 0.46, (44 mo) | N/A | 174 | 169 | 7.1 vs 7.4 P = 0.47 | N/A |
| Kang et al[18] "COREAN" Multicenter | N/A | N/A | N/A | N/A | Lap-5.6 Open-5.3 | 170 | 170 | 17 vs 18 P = 0.08 | 5% vs 7% P = 0.77 |
| Jayne et al[19] "CLASSIC" update Multicenter | 21.9% vs 21.9% P = 0.86, (5 yr) | 9.4% vs 7.6% P = 0.74, (5 yr) | 53.2% vs 52.1% P = 0.95, (5 yr) | 60.3% vs 52.9% P = 0.13, (5 yr) | N/A | 128 | 253 | N/A | N/A |
| Lujan et al[20] Single center | N/A | 4.8% vs 5.3% P = 0.78, (5 yr) | 84.8% vs 81% P = 0.9, (5 yr) | 72.1% vs 75.3% P = 0.98, (5 yr) | Lap-5.5 Open-6.2 | 103 | 101 | 13.6 vs 11.6 P = 0.02 | 4% vs 3% P = 0.4 |
| Ng et al[21] Single center | 12.3% vs 18.1% P = 0.37, (10 yr) | 7.1% vs 4.9% P = 0.68, (10 yr) | 82.9% vs 80.4% P = 0.69, (10 yr) | 83.5% vs 78% P = 0.59, (10 yr) | 12-15 | 77 | 76 | 11.5 vs 12 P = 0.7 | 2.6% vs 1.3% P = 0.62 |
| Ng et al[22] Single center | 15% vs 25% P = 0.6, (5 yr) | 5% vs 11% = 0.6, (5 yr) | 78.1% vs 73.6% P = 0.55, (5 yr) | 75.2% vs 76.5% P = 0.2, (5 yr) | ≤ 5 | 48 | 51 | 12.4 vs 13 P = 0.72 | 5.8% vs 4.1% P = NS |
| Pechlivanides et al[23] Multicenter | N/A | N/A | N/A | N/A | Lap-6 Open-8 | 39 | 34 | 19.2 vs 19.2 P = 0.2 | N/A |
| Braga et al[24] Single center | N/A | 4% vs 5.3% P = 0.97 (5 yr) | N/A | No difference (5 yr) | Lap-9.1 Open-8.6 | 85 | 83 | 12.7 vs 13.6 P = NA | 1.3% vs 2.4% P = NA |
AV: Anal verge; N/A: Not applicable; OS: Overall survival; DFS: Disease free survival; LR: Local recurrence; DR: Distant recurrence; LN: Lymph nodes; CRM: Circumferential margins; NS: Non-significant; NA: Not available.