Table 3.
ITT population | Patients experiencing pre-operative PND (at least one VAS >30 mm) | |||||
---|---|---|---|---|---|---|
Tisseel/Tissucol N = 149 | Sutures N = 150 | p value | Tisseel/Tissucol N = 60 | Sutures N = 62 | p value | |
Pain | ||||||
Mean ± SD | 3.9 ± 11.5 | 5.9 ± 14.8 | 0.113 | 6.6 ± 14.6 | 10.7 ± 19.3 | 0.195 |
Median (range) | 0 (0–76) | 0 (0–90) | 0 (0–76) | 0 (0–90) | ||
Interquartile range | 0–0 | 0–0 | 0–5 | 0–15 | ||
Numbness | ||||||
Mean ± SD | 4.1 ± 10.6 | 7.4 ± 14.6 | 0.019* | 3.4 ± 8.6 | 11.0 ± 19.7 | 0.008* |
Median (range) | 0 (0–91) | 0 (0–100) | 0 (0–50) | 0 (0–100) | ||
Interquartile range | 0–0 | 0–10 | 0–0 | 0–19 | ||
Groin discomfort | ||||||
Mean ± SD | 7.1 ± 14.6 | 10.2 ± 16.8 | 0.049* | 9.0 ± 14.6 | 17.3 ± 21.5 | 0.018* |
Median (range) | 0 (0–75) | 0 (0–80) | 0 (0–50) | 7.5 (0–80) | ||
Interquartile range | 0–10 | 0–20 | 0–18 | 0–25 |
ITT intention-to-treat, PND pain, numbness and pain discomfort, SD standard deviation, VAS visual analogue scale
* p < 0.05 for Tisseel versus suture subgroup, non-parametric mixed covariance analysis