Objective: This multicenter randomized clinical trial compared cryo stripping of the great saphenous vein (GSV) with conventional stripping.
Methods: The study randomized 494 patients with symptomatic (CEAP) clinical severity class 2 to 4 to cryo stripping (n = 249) or conventional stripping (n = 245). The primary outcome was residual GSV 6 months after surgery measured by venous duplex ultrasound imaging. Secondary outcomes were quality of life, operation time, and postoperative neural damage. Duration of follow-up was 6 months. Quality of life was measured at 6 and 26 weeks postoperatively with the Aberdeen Varicose Vein Questionnaire (AVVQ) and Medical Outcomes Study Short-Form 36 (SF-36) Health Survey.
Results: The two groups were well matched at baseline. The percentage of patients with residual GSV at 6 months (primary outcome) was 44% (102 of 230) in the cryo group and 15% (33 of 215) in the conventional group (difference 29%; 95% confidence interval [CI], 21%-37%, P < .001). Median operation time was significantly shorter in the cryo group (30 minutes) compared with the conventional group (39 minutes). Neural damage was 12% in both groups, and thus not significantly different. Scores on the subdomains of the SF-36 showed no significant change between the groups. The AVVQ after conventional stripping was 8.0, which was a better result than the 11.7 result after cryo stripping (difference 2.6 points; 95% CI, 1.0-4.2; P = .001, repeated measurements analysis of variance with adjustment for baseline scores).
Conclusions: Cryo stripping accounts for numerous procedural failures and hence residual GSV in patients. The AVVQ showed small but significantly better results for patients after a conventional stripping. Cryo stripping has no benefits over conventional stripping.