Table 1.
Primary and secondary success rates after FiLaC™
| Patient characteristics | n | Primary healing | Secondary healing# | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Yes (%) | No (%) | HRR (95% CI) | p $ | Yes (%) | No (%) | HRR (95% CI) | p $ | ||
| n | 117 | 75 (64.1) | 42 (35.9) | 103 (88.0) | 14 (12.0) | ||||
| Age& | 47 (19) | 45.5 (19) | 0.278 | 46 (17) | 42.5 (20) | 0.980 | |||
| Sex | |||||||||
| Male | 82 | 51 (62.2) | 31 (37.8) | *** | 71 (86.6) | 11 (13.4) | *** | ||
| Female | 35 | 24 (68.5) | 11 (31.5) | 1.10 (0.83,1.50) | 0.537 | 32 (91.4) | 3 (8.6) | 1.06 (0.92,1.21) | 0.550 |
| Aetiology | |||||||||
| Cryptoglandular | 104 | 66 (63.5) | 38 (36.5) | *** | 91 (87.5) | 13 (12.5) | *** | ||
| Crohn | 13 | 9 (69.2) | 4 (30.8) | 1.09 (0.74,1.61) | 0.768 | 12 (92.3) | 1 (7.7) | 1.05 (0.89,1.25) | 1.000 |
| Park classification | |||||||||
| I | 8 | 8 (100.0) | 0 (0.0) | 1.63 (1.39,1.93) | 0.048 | 8 (100.0) | 0 (0.0) | 1.12 (1.05,1.21) | 1.000 |
| II | 90 | 55 (61.1) | 35 (38.9) | *** | 80 (88.9) | 10 (11.1) | *** | ||
| III | 13 | 8 (61.5) | 5 (38.5) | 1.01 (0.64,1.60) | 1.000 | 10 (76.9) | 3 (23.1) | 0.87 (0.64,1.18) | 0.211 |
| IV | 6 | 4 (66.7) | 2 (33.3) | 1.09 (0.61,1.97) | 1.000 | 5 (83.3) | 1 (16.7) | 0.94 (0.65,1.35) | 0.528 |
| Closure technique | |||||||||
| MSAF | 51 | 34 (66.7) | 17 (33.3) | 1.02 (0.77,1.35) | 1.000 | 46 (90.2) | 5 (9.8) | 1.04 (0.91,1.20) | 0.760 |
| Anodermal flap | 52 | 34 (65.4) | 18 (34.6) | *** | 45 (86.5) | 7 (13.5) | *** | ||
| Mucosal flap | 2 | 1 (50.0) | 1 (50.0) | 0.76 (0.19,3.10) | 1.000 | 1 (50.0) | 1 (50.0) | 0.58 (0.14,2.32) | 0.277 |
| Suture closure | 12 | 6 (50.0) | 6 (50.0) | 0.76 (0.42,1.39) | 0.341 | 11 (91.7) | 1 (8.3) | 1.06 (0.87,1.30) | 1.000 |
| Prior fistula repair§ | |||||||||
| Yes | 16 | 9 (56.3) | 7 (43.7) | 0.86 (0.55,1.36) | 0.577 | 13 (81.3) | 3 (18.7) | 0.91 (0.71,1.16) | 0.405 |
| No | 101 | 66 (65.3) | 35 (34.7) | *** | 90 (89.1) | 11 (10.9) | *** | ||
HRR healing rate ratio, MSAF mucosal–submucosal advancement flap
$ p value from Fisher’s exact test except for age, where the p value is from a Kruskal–Wallis test
*** Indicates reference group; 9% CI 95% confidence interval
# Defined as healing at the end of study
§ Defined as any surgery except I/D of abscess and seton replacement
& Median (interquartile range)