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1Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea
2Biostatistics Collaboration Team, Research Institute and Hospital, National Cancer Center, Goyang, Korea
© 2024 The Korean Society of Coloproctology
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Conflict of interest
No potential conflict of interest relevant to this article was reported.
Funding
This study was supported by a grant from the National Cancer Center of Korea (No. 2110201-3).
Author contributions
Conceptualization: JHO; Data curation: JHO, MWL; Formal analysis: MWL, DEL; Funding acquisition: SCP; Investigation: MWL; Methodology: JHO, MWL; Project administration: JHO, MWL; Resources: JHO, SCP, DWL, HJC, DYK; Software: KY, DEL; Supervision: JHO, SCP, DWL, SSP, KY, KSH, DKS, CWH, BK, BCK, HJC, DYK; Validation: JHO, MWL; Visualization: MWL, DEL; Writing–original draft: MWL; Writing–review & editing: JHO, SCP, DWL, SSP, KY, KSH, DKS, CWH, BK, BCK, HJC, DYK, DWL. All authors read and approved the final manuscript.
Values are presented as mean±standard deviation or number (%). P-values of continuous variables were calculated using 2 sample t-test or Wilcoxon rank sum test, whereas those of categorical variables were calculated using chi-square test or Fisher exact test.
HL, high ligation; LL, low ligation; RT, radiotherapy; AV, anal verge; LN, lymph node; PRM, proximal resection margin; DRM, distal resection margin.
Variable | HL group (n=244) | LL group (n=301) | P-value* |
---|---|---|---|
Complication | 47 (19.3) | 57 (18.9) | >0.999 |
Superficial or deep incisional SSI | 3 (1.2) | 2 (0.7) | 0.661 |
Postoperative bleeding | 1 (0.4) | 5 (1.7) | 0.448 |
Anastomosis site bleeding | 0 (0) | 3 (1.0) | |
Intra-abdominal bleeding | 1 (0.4) | 2 (0.7) | |
Ileus | 12 (4.9) | 20 (6.6) | 0.503 |
Anastomotic leakage | 11 (4.5) | 13 (4.3) | >0.999 |
Urinary retention | 9 (3.7) | 9 (3.0) | 0.832 |
Ischemic colitis | 3 (1.3) | 1 (0.3) | 0.329 |
Other | 0.863 | ||
Acute pyelonephritis | 0 (0) | 1 (0.3) | |
Cellulitis | 1 (0.4) | 0 (0) | |
Cystitis | 1 (0.4) | 1 (0.3) | |
Delirium | 1 (0.4) | 1 (0.3) | |
Necrotizing fasciitis | 0 (0) | 1 (0.3) | |
Perianal abscess | 0 (0) | 1 (0.3) | |
Rectovaginal fistula | 0 (0) | 2 (0.7) |
Variable | HL group (n=244) | LL group (n=301) | P-valuea* |
---|---|---|---|
Recurrence | 35 (14.3) | 48 (15.9) | 0.691 |
Recurrence site | 0.195 | ||
Local | 0 (0) | 4 (1.3) | |
Systemic | 30 (12.3) | 29 (9.6) | |
Local and systemic | 3 (1.2) | 7 (2.3) | |
Local recurrence site | 0.334 | ||
Anterior | 1 (0.4) | 1 (0.3) | |
Posterior | 0 (0) | 3 (1.0) | |
Lateral | 2 (0.8) | 6 (2.0) | |
Anastomosis | 0 (0) | 1 (0.3) | |
Systemic recurrence site | |||
Liver | 10 (4.1) | 14 (4.7) | 0.918 |
Lung | 24 (9.8) | 24 (8.0) | 0.541 |
Peritoneal seeding | 4 (1.6) | 5 (1.7) | >0.999 |
Bone | 2 (0.8) | 2 (0.7) | >0.999 |
Para-aortic LNs | 5 (2.0) | 2 (0.7) | 0.252 |
Difference |
HL group (n=244) |
LL group (n=301) |
P-value* | |||
---|---|---|---|---|---|---|
No. of patients | Median (range) | No. of patients | Median (range) | |||
Fecal Incontinence Severity Index | ||||||
Postoperation 3 mo − Preoperation | 124 | 0 (–31 to −49) | 135 | 0 (–16 to 49) | 0.359 | |
Postoperation 12 mo − Preoperation | 120 | 0 (–31 to 45) | 167 | 0 (–16 to 45) | 0.023 | |
Postoperation 36 mo − Preoperation | 91 | 0 (–31 to 32) | 124 | 0 (–13 to 20) | 0.071 | |
International Prostate Symptom Score | ||||||
Postoperation 3 mo − Preoperation | 129 | 0 (–22 to 17) | 174 | 0 (–14 to 25) | 0.296 | |
Postoperation 12 mo − Preoperation | 120 | 0 (–22 to 29) | 166 | 0 (–26 to 26) | 0.602 | |
Postoperation 36 mo − Preoperation | 93 | 0 (–20 to 23) | 124 | 0 (–14 to 25) | 0.368 | |
International Index of Erectile Function | ||||||
Postoperation 3 mo − Preoperation | 8 | –0.5 (–11 to 13) | 18 | 0 (–13 to 8) | 0.537 | |
Postoperation 12 mo − Preoperation | 17 | 0 (–13 to 9) | 18 | 0 (–9 to 8) | 0.879 | |
Postoperation 36 mo − Preoperation | 9 | 0 (–1 to 5) | 13 | 0 (–6 to 4) | 0.260 |
Characteristic | HL group (n=244) | LL group (n=301) | P-value |
---|---|---|---|
Age (yr) | 60.7±10.9 | 61.0±11.3 | 0.800 |
Male sex | 165 (67.6) | 194 (64.5) | 0.493 |
Body mass index (kg/m2) | 23.6±3.2 | 24.0±3.1 | 0.187 |
Comorbidity | 147 (60.2) | 164 (54.5) | 0.206 |
Preoperative chemotherapy and/or RT | 77 (31.6) | 83 (27.6) | 0.357 |
Tumor level from AV (cm) | 9.1±3.9 | 9.6±3.7 | 0.092 |
≤5 | 53 (21.7) | 45 (15.0) | 0.053 |
>5 | 191 (78.3) | 256 (85.0) | |
Tumor level | 0.122 | ||
Low (AV, >0–5 cm) | 53 (21.7) | 45 (15.0) | |
Mid (AV, >5–10 cm) | 110 (45.1) | 146 (48.5) | |
High (AV, >10–15 cm) | 81 (33.2) | 110 (36.5) | |
Tumor size (maximum diameter) (cm) | 3.9±2.1 | 3.4±2.0 | 0.006 |
ypT cateogory | 0.122 | ||
0/is | 11 (4.5) | 15 (5.0) | |
1 | 29 (11.9) | 57 (18.9) | |
2 | 58 (23.8) | 71 (23.6) | |
3 | 132 (54.1) | 149 (49.5) | |
4 | 14 (5.7) | 9 (3.0) | |
ypN category | 0.732 | ||
N+ | 96 (39.3) | 113 (37.5) | |
N– | 148 (60.7) | 188 (62.5) | |
ypStage | 0.330 | ||
0 | 11 (4.5) | 14 (4.7) | |
I | 64 (26.2) | 99 (32.9) | |
II | 68 (27.9) | 69 (22.9) | |
III | 101 (41.4) | 119 (39.5) | |
No. of harvested LNs | 23.0±10.1 | 20.4±9.1 | 0.002 |
≥12 | 230 (94.3) | 275 (91.4) | 0.260 |
Length of PRM (cm) | 12.6±6.0 | 10.9±4.1 | <0.001 |
Length of DRM (cm) | 2.2±1.4 | 2.8±1.6 | <0.001 |
Inadequate DRM (<2 cm) | 111 (45.9) | 92 (30.6) | <0.001 |
Intraoperative bleeding (mL) | 73.9±101.2 | 60.1±58.1 | 0.079 |
Operative time (min) | 185.7±58.8 | 180.8±52.5 | 0.308 |
Diverting ileostomy | 97 (39.8) | 137 (45.5) | 0.206 |
Splenic flexure mobilization | 31 (12.7) | 16 (5.3) | 0.004 |
Postoperative stay (day) | 10.3±5.6 | 9.9±17.1 | 0.740 |
Postoperative chemotherapy and/or RT | 152 (62.3) | 160 (53.2) | 0.040 |
Variable | Overall survival | Relapse-free survival | ||||||
---|---|---|---|---|---|---|---|---|
Univariable analysis | Multivariable analysis | Univariable analysis | Multivariable analysis | |||||
HR (95% CI) | P-value | HR (95% CI) | P-value | HR (95% CI) | P-value | HR (95% CI) | P-value | |
Group | - | - | - | - | ||||
High ligation | Reference | - | Reference | - | ||||
Low ligation | 0.716 (0.429–1.194) | 0.200 | 1.078 (0.697–1.668) | 0.734 | ||||
Sex | - | - | ||||||
Female | Reference | - | - | - | Reference | - | ||
Male | 2.485 (1.257–4.912) | 0.009 | 2.154 (1.085–4.275) | 0.028 | 1.806 (1.082–3.013) | 0.024 | ||
Age (yr) | - | - | - | - | ||||
≥60 | Reference | - | Reference | - | ||||
<60 | 0.717 (0.429–1.199) | 0.205 | 0.916 (0.595–1.411) | 0.692 | ||||
BMI (kg/m2) | - | - | - | - | ||||
<25 | Reference | - | Reference | - | ||||
≥25 | 1.026 (0.593–1.773) | 0.928 | 1.525 (0.985–2.363) | 0.059 | ||||
Comorbidity | - | - | ||||||
No | Reference | - | - | - | Reference | - | ||
Yes | 1.905 (1.094–3.318) | 0.023 | 1.948 (1.118–3.395) | 0.019 | 0.958 (0.622–1.476) | 0.846 | ||
Neoadjuvanta | - | - | - | - | ||||
No | Reference | - | Reference | - | ||||
Yes | 0.988 (0.573–1.702) | 0.964 | 1.216 (0.773–1.911) | 0.397 | ||||
Tumor level | 0.255 | - | - | 0.506 | - | - | ||
Low | Reference | - | - | |||||
Mid | 1.194 (0.629–2.268) | 0.587 | 1.025 (0.584–1.798) | 0.932 | ||||
High | 0.684 (0.310–1.511) | 0.348 | 0.765 (0.408–1.433) | 0.403 | ||||
T category | ||||||||
0–2 | Reference | - | - | - | Reference | - | - | - |
3–4 | 3.145 (1.698–5.825) | <0.001 | 2.326 (1.217–4.446) | 0.011 | 2.815 (1.702–4.657) | <0.001 | 2.323 (1.322–4.083) | 0.003 |
N category | ||||||||
N0 | Reference | - | - | - | Reference | - | - | - |
N+ | 2.474 (1.472–4.159) | 0.001 | 1.945 (1.128–3.353) | 0.017 | 3.921 (2.472–6.218) | <0.001 | 4.891 (2.825–8.469) | <0.001 |
No. of harvest LNs | - | - | - | - | ||||
<12 | Reference | - | Reference | - | ||||
≥12 | 2.114 (0.66–6.775) | 0.208 | 1.050 (0.483–2.280) | 0.903 | ||||
DRM (cm) | - | - | - | - | ||||
<2 | Reference | - | Reference | - | ||||
≥2 | 1.205 (0.707–2.056) | 0.493 | 1.337 (0.846–2.114) | 0.213 | ||||
Operation time (min) | 1.312 (1.019–1.688) | 0.035 | 1.281 (1.035–1.586) | 0.023 | 1.313 (1.063–1.621) | 0.011 | ||
Adjuvantb | - | - | ||||||
No | Reference | - | Reference | - | - | - | ||
Yes | 1.139 (0.675–1.922) | 0.627 | 1.380 (0.880–2.164) | 0.161 | 0.396 (0.228–0.686) | 0.001 |
Variable | HL group (n=244) | LL group (n=301) | P-value |
---|---|---|---|
Complication | 47 (19.3) | 57 (18.9) | >0.999 |
Superficial or deep incisional SSI | 3 (1.2) | 2 (0.7) | 0.661 |
Postoperative bleeding | 1 (0.4) | 5 (1.7) | 0.448 |
Anastomosis site bleeding | 0 (0) | 3 (1.0) | |
Intra-abdominal bleeding | 1 (0.4) | 2 (0.7) | |
Ileus | 12 (4.9) | 20 (6.6) | 0.503 |
Anastomotic leakage | 11 (4.5) | 13 (4.3) | >0.999 |
Urinary retention | 9 (3.7) | 9 (3.0) | 0.832 |
Ischemic colitis | 3 (1.3) | 1 (0.3) | 0.329 |
Other | 0.863 | ||
Acute pyelonephritis | 0 (0) | 1 (0.3) | |
Cellulitis | 1 (0.4) | 0 (0) | |
Cystitis | 1 (0.4) | 1 (0.3) | |
Delirium | 1 (0.4) | 1 (0.3) | |
Necrotizing fasciitis | 0 (0) | 1 (0.3) | |
Perianal abscess | 0 (0) | 1 (0.3) | |
Rectovaginal fistula | 0 (0) | 2 (0.7) |
Variable | HL group (n=244) | LL group (n=301) | P-valuea |
---|---|---|---|
Recurrence | 35 (14.3) | 48 (15.9) | 0.691 |
Recurrence site | 0.195 | ||
Local | 0 (0) | 4 (1.3) | |
Systemic | 30 (12.3) | 29 (9.6) | |
Local and systemic | 3 (1.2) | 7 (2.3) | |
Local recurrence site | 0.334 | ||
Anterior | 1 (0.4) | 1 (0.3) | |
Posterior | 0 (0) | 3 (1.0) | |
Lateral | 2 (0.8) | 6 (2.0) | |
Anastomosis | 0 (0) | 1 (0.3) | |
Systemic recurrence site | |||
Liver | 10 (4.1) | 14 (4.7) | 0.918 |
Lung | 24 (9.8) | 24 (8.0) | 0.541 |
Peritoneal seeding | 4 (1.6) | 5 (1.7) | >0.999 |
Bone | 2 (0.8) | 2 (0.7) | >0.999 |
Para-aortic LNs | 5 (2.0) | 2 (0.7) | 0.252 |
Difference | HL group (n=244) |
LL group (n=301) |
P-value |
|||
---|---|---|---|---|---|---|
No. of patients | Median (range) | No. of patients | Median (range) | |||
Fecal Incontinence Severity Index | ||||||
Postoperation 3 mo − Preoperation | 124 | 0 (–31 to −49) | 135 | 0 (–16 to 49) | 0.359 | |
Postoperation 12 mo − Preoperation | 120 | 0 (–31 to 45) | 167 | 0 (–16 to 45) | 0.023 | |
Postoperation 36 mo − Preoperation | 91 | 0 (–31 to 32) | 124 | 0 (–13 to 20) | 0.071 | |
International Prostate Symptom Score | ||||||
Postoperation 3 mo − Preoperation | 129 | 0 (–22 to 17) | 174 | 0 (–14 to 25) | 0.296 | |
Postoperation 12 mo − Preoperation | 120 | 0 (–22 to 29) | 166 | 0 (–26 to 26) | 0.602 | |
Postoperation 36 mo − Preoperation | 93 | 0 (–20 to 23) | 124 | 0 (–14 to 25) | 0.368 | |
International Index of Erectile Function | ||||||
Postoperation 3 mo − Preoperation | 8 | –0.5 (–11 to 13) | 18 | 0 (–13 to 8) | 0.537 | |
Postoperation 12 mo − Preoperation | 17 | 0 (–13 to 9) | 18 | 0 (–9 to 8) | 0.879 | |
Postoperation 36 mo − Preoperation | 9 | 0 (–1 to 5) | 13 | 0 (–6 to 4) | 0.260 |
Values are presented as mean±standard deviation or number (%). P-values of continuous variables were calculated using 2 sample t-test or Wilcoxon rank sum test, whereas those of categorical variables were calculated using chi-square test or Fisher exact test. HL, high ligation; LL, low ligation; RT, radiotherapy; AV, anal verge; LN, lymph node; PRM, proximal resection margin; DRM, distal resection margin.
HR, hazard ratio; CI, confidence interval; BMI, body mass index; LN, lymph node; DRM, distal resection margin. Neoadjuvant chemotherapy and/or radiotherapy. bAdjuvant chemotherapy and/or radiotherapy.
Values are presented as number (%). HL, high ligation; LL, low ligation; SSI, surgical site infection. P<0.05 (P-values were calculated using the chi-square test or Fisher exact test).
Values are presented as number (%). HL, high ligation; LL, low ligation; LN, lymph node. P<0.05 (P-values were calculated using the chi-squared or Fisher exact test).
HL, high ligation; LL, low ligation. P<0.05 (P-values were calculated using the Wilcoxon rank sum test).