Table 10. Major Adverse Events in RCT of RFA vs. Surgery.
Author, Study Size (RFA, Surgery) | Follow-Up | RFA Major Adverse Events* | Surgery Major Adverse Events |
---|---|---|---|
Hinchliffe et al., 2006 | 6 week F-UP | 0 | 1 superficial post-operative wound infection |
N = 16 pairs, recurrent VV | 1 persistent thrombophlebitis | ||
Lurie et al., 2003, 2005 N = 43, 36 |
3 week F-Up | 3 surgical wound thrombosis | 4 infections 4 surgical wound thrombosis |
Rautio et al., 2002 N = 15, 13 |
2 month F-Up | 3 clinical thrombophlebitis 1 thermal skin injury | 0 |
Perala et al., , 2005 of Rautio’s trial | 3 Yr F-Up | 1 saphenous nerve injury 1 extended period superficial thrombophlebitis | 5 saphenous nerve injuries |
Stotter et al., 2006 N = 20, 40 |
6 Week F-Up | 0 | 0 |
Subramonia et al., 2009 N = 48, 45 |
5 week F-Up | 0 | 0 |
Total = 292 (142,150) | 9 (6.3%) 95% CI; 3.4% - 11.6% |
17 (11.3 %) 95% CI; 7.2% - 17.4% |
*Major adverse events include deep venous thrombosis,, pulmonary embolism,, thermal injury, or saphenous vein injury