A randomized trial of cryo stripping versus conventional stripping of the great saphenous vein.
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.
Klem
Taco M A L
TM
Department of Vascular Surgery of Sint Franciscus Hospital, Rotterdam, The Netherlands. t.klem@wxs.nl
Schnater
J Marco
JM
Schütte
P Ronald
PR
Hop
Wim
W
van der Ham
Arie C
AC
Wittens
Cornelis H A
CH
D000328:Adult; D000368:Aged; D003452:Cryosurgery / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010523:Peripheral Nervous System Diseases / Q000209:etiology; D011788:Quality of Life; D012086:Reoperation; D012501:Saphenous Vein / Q000000981:diagnostic imaging / Q000601:surgery*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D014689:Venous Insufficiency / Q000000981:diagnostic imaging / Q000601:surgery*