Table 2 Primary endpoint and secondary endpoints
Characteristic | Groups | P value | Group1 (FTMDT) | P value | ||
|---|---|---|---|---|---|---|
1(FTMDT) | 2(Conventional) | Subgroup 1a | Subgroup 1b | |||
Total in-hospital days, M (IQR) | 13 (11–17) | 23.5 (15–42) | 0.0001 | 13 (11–16) | 14 (12–17) | 0.1951 |
Surgery | ||||||
 Surgery duration, min, M (IQR) | 155 (129–180) | 150 (122–183) | 0.8005 | 155 (140–180) | 150 (120–180) | 0.1028 |
 Blood loss, mL, M (IQR)) | 100 (50–200) | 150 (100–200) | 0.0014 | 100 (50–150) | 100 (100–200) | 0.0150 |
 Intraoperative complications, n (%) | 2 (1.2) | 1 (0.6) | 1.0000 | 0 (0.0) | 2 (2.4) | 0.1480 |
 Postoperative in-hospital complications, n (%) | 11 (6.4) | 25 (14.7) | 0.0140 | 5 (5.7) | 6 (7.1) | 0.7700 |
  Wound infection | 1 (1) | 0 (0) | 1.0000 | 1 (1) | 0 (0) | 1.0000 |
  Anastomotic leakage | 0 (0) | 1 (1) | 1.0000 | 0 (0) | 1 (1) | 1.0000 |
 Readmission < 30 days, n (%) | 10 (5.8) | 9 (5.3) | 0.8340 | 6 (6.9) | 4 (4.7) | 0.5390 |
 Ambulation onset, h, M, (IQR) | 24 (24–48) | 48 (48–72) | 0.0001 | 24 (24–48) | 48 (24–48) | 0.1064 |
 Days to flatus, M ± SD | 56 ± 26 | 71 ± 27 | < 0.0001 | 51 ± 25 | 62 ± 26 | 0.0121 |
 Days to defecation, M (IQR) | 85 (55–97) | 96 (69–129) | 0.0010 | 76 (48–96) | 90 (72–103) | 0.0345 |
 Days to fluid diet resumption, M (IQR) | 24 (24–48) | 96 (72–120) | 0.0001 | 24 (24–24) | 24 (24–48) | 0.1624 |
 Postoperative days, M (IQR) | 6 (5–7) | 9 (7–11) | 0.0001 | 6 (4–8) | 6 (5–7) | 0.2160 |
 Surgical protocol compliance, M (IQR) | 9 (8–10) | 12 (12–12) | 0.0001 | 9 (8–10) | 9 (8–10) | 0.2235 |
 Surgical costs, RMB, M (IQR) | 29,678 (25868–35,045) | 33,559 (29627–41,452) | 0.0001 | 32,811(28062–37,117) | 27,156(24490–32,684) | 0.0001 |
Chemotherapy | ||||||
 Patients received chemotherapy, n (%) | 105 (62.5) | 103 (63.2) | 0.9100 | 55 (63.2) | 50 (61.7) | 0.8740 |
 Patients with any grade AEs, n (%) | 94 (94.0) | 92 (96.8) | 0.4990 | 48 (92.3) | 46 (95.8) | 0.6790 |
 Patients with grade 3–4 AEs, n (%) | 28 (28.0) | 28 (29.5) | 0.875 | 14 (26.9) | 14 (29.2) | 0.8270 |
 Cost for chemotherapy, RMB, M (IQR) | 100,999 (59021–115,102) | 104,256 (59954–128,233) | 0.1410 | 100,414 (38221–117,460) | 102,353 (64528–113,722) | 0.7274 |
Survival | ||||||
 5-year DFS (%, 95CI) | 82.6 (75.6–87.8) | 80.0 (73.0–85.4) | 0.2780 | 81.2 (70.8–88.3) | 83.7 (72.8–90.5) | 0.7560 |
 5-year OS (%, 95CI) | 87.1 (80.7–91.5) | 87.1 (80.8–91.4) | 0.7420 | 83.7 (73.6–90.2) | 90.7% (81.5–95.5) | 0.2540 |