Table 1 Demographic and clinicopathological characteristics of patients in the modified intention-to-treat population

From: Preservation versus resection of Denonvilliers’ fascia in total mesorectal excision for male rectal cancer: follow-up analysis of the randomized PUF-01 trial

Characteristic

Exp-group (n = 122)

Con-group (n = 120)

Age (years)

57.8 ± 8.4

58.2 ± 8.7

BMI (kg/m2)

22.3 ± 3.0

22.7 ± 3.4

ECOG performance status

  

  0

84 (68.9%)

85 (70.8%)

  1

38 (31.1%)

35 (29.2%)

ASA grading

  

  I

78 (63.9%)

74 (61.7%)

  II

37 (30.3%)

38 (31.7%)

  III

7 (5.7%)

8 (6.7%)

Comorbidities

  

  None

81 (66.4%)

74 (61.7%)

  ≥1

41 (33.6%)

46 (38.3%)

Neoadjuvant chemotherapy

  

  Yes

33 (27.0%)

35 (29.2%)

  No

89 (73.0%)

85 (70.8%)

Postoperative adjuvant therapy

  

  Capecitabine

10 (8.2%)

8 (6.7%)

  CapeOX

51 (41.8%)

49 (40.8%)

  mFOLFOX6

11 (9.0%)

9 (7.5%)

  None

50 (41.0%)

54 (45.0%)

Tumor size (cm)

3.5 ± 1.3

3.3 ± 1.5

Tumor location

  

   Anterior

28 (23.0%)

33 (27.5%)

   Lateral

57 (46.7%)

50 (41.7%)

   Posterior

37 (30.3%)

37 (30.8%)

Tumor height (cm)

7.4 ± 2.3

7.5 ± 2.4

Proximal margin (cm)

10.1 ± 2.1

10.1 ± 1.6

Distal margin (cm)

3.1 ± 1.2

3.0 ± 1.3

Retrieved lymph nodes (No.)

19.0 ± 9.7

17.2 ± 8.4

Metastatic lymph nodes (No.)

1.3 ± 4.0

1.7 + 3.9

Histology

  

   Differentiated

109 (89.3%)

105 (87.5%)

   Poorly differentiated

13 (10.7%)

15 (12.5%)

TME grading classification

  

   I

118 (96.7%)

116 (96.7%)

   II

4 (3.3%)

4 (3.3%)

   III

0

0

Pathologic T stage

  

   1

14 (11.5%)

16 (13.3%)

   2

24 (19.7%)

27 (22.5%)

   3

40 (32.8%)

32 (26.7%)

   4

44 (36.1%)

45 (37.5%)

Pathologic N stage

  

   0

78 (63.9%)

68 (56.7%)

   1

30 (24.6%)

30 (25.0%)

   2

14 (11.5%)

22 (18.3%)

Pathologic TNM stage

  

   I

33 (27.0%)

35 (29.2%)

   II

45 (36.9%)

33 (27.5%)

   III

44 (36.1%)

52 (43.3%)

  1. BMI body mass index, ECOG Eastern Cooperative Oncology Group, ASA American Society of Anesthesiologists.