Table 1.
Baseline characteristics (n, % unless otherwise stated): ITT population and patients experiencing pre-operative PND
| ITT population | Patients experiencing pre-operative PND (at least one VAS >30 mm) | |||
|---|---|---|---|---|
| Tisseel/Tissucol N = 158 | Sutures N = 158 | Tisseel/Tissucol N = 64 | Sutures N = 66 | |
| Age, median (range), years | 58 (19–84) | 59 (21–80) | 58 (19–84) | 55 (21–77) |
| Employment status | ||||
| Blue collar | 37 (23.7) | 39 (25.0) | 18 (28.6) | 23 (34.8) |
| White collar | 49 (31.4) | 45 (28.8) | 17 (27.0) | 16 (24.2) |
| Self-employed | 14 (9.0) | 14 (9.0) | 4 (6.3) | 3 (4.5) |
| Not employed | 3 (1.9) | 3 (1.9) | 3 (4.8) | 0 (0.0) |
| Retired | 51 (32.7) | 55 (35.3) | 21 (33.3) | 24 (36.4) |
| If employed | ||||
| Full time | 96 (96.0) | 95 (96.9 | 36 (92.3) | 40 (95.2) |
| Part time | 4 (4.0) | 3 (3.1) | 3 (7.7) | 2 (4.8) |
| BMI, mean (SD) | 25.5 (2.9) | 25.5 (2.6) | 25.3 (3.0) | 25.5 (2.6) |
| General health | ||||
| ASA I/II n (%) | 148 (94.2) | 153 (96.9) | 59 (92.2) | 62 (93.9) |
| ASA III n (%) | 9 (5.7) | 5 (3.2) | 5 (7.8) | 4 (6.1) |
| Paina | ||||
| None (0) | 56 (35.4) | 59 (37.3) | 12 (18.8) | 11 (16.7) |
| Mild (1–30) | 65 (41.1) | 59 (37.3) | 15 (23.4) | 15 (22.7) |
| Moderate (31–60) | 28 (17.7) | 29 (18.4) | 28 (43.8) | 29 (43.9) |
| Severe (61–100) | 9 (5.7) | 11 (7.0) | 9 (14.4) | 11 (16.7) |
| Numbnessa | ||||
| None (0) | 113 (71.5) | 110 (69.6) | 46 (71.9) | 45 (68.2) |
| Mild (1–30) | 33 (20.9) | 31 (19.6) | 6 (9.4) | 4 (6.1) |
| Moderate (31–60) | 6 (3.8) | 14 (8.9) | 6 (9.4) | 14 (21.2) |
| Severe (61–100) | 6 (3.8) | 3 (1.9) | 6 (9.4) | 3 (4.5) |
| Groin discomforta | ||||
| None (0) | 51 (32.3) | 47 (29.7) | 7 (10.9) | 6 (9.1) |
| Mild (1–30) | 60 (38.0) | 63 (40.0) | 10 (15.6) | 12 (18.2) |
| Moderate (31–60) | 38 (24.1) | 38 (24.1) | 38 (59.4) | 38 (57.6) |
| Severe (61–100) | 9 (5.7) | 10 (6.3) | 9 (14.1) | 10 (15.2) |
ASA American Society of Anesthesiology categorisation, BMI body mass index, ITT intention-to-treat, PND pain, numbness and groin discomfort, SD standard deviation
aAs assessed by the visual analogue scale (VAS), ranging from 0 mm (none) to 100 mm (worst conceivable)