OBJECTIVES: To assess the improvement in quality of life and complication rates in patients undergoing great saphenous vein (GSV) stripping using two different techniques. DESIGN: A single centre prospective randomised trial. PATIENTS AND METHODS: 160 patients with primary varicose veins and GSV incompetence were randomised to either conventional stripping or cryostripping combined with phlebectomy of varices. Quality of life was assessed as the primary outcome measure prior to surgery and 6 months later, using the SF-36 questionnaire. Operative data, pain score and procedure related complications were evaluated as secondary outcome measures. We assessed the area of bruising and symptoms attributable to saphenous nerve injury. RESULTS: The number of completely analysed patients was 77 in the conventional stripping group and 69 in the cryostripping group. When comparing the preoperative SF-36 scores to the results after 6 months, there was an improvement in all eight domains, which reached statistical significance in six domains in both groups. The mean area of bruising measured in the thigh was significantly greater in the conventional stripping group (161 S.D. 63cm(2) versus 123 S.D. 52cm(2), p=0.010, Student's t test). The number of patients with paraesthesia due to saphenous nerve injury was numerically lower in the cryostripping group at one week [15 (22%), versus 28 (34%), N.S.] but no difference was observed at 6 months. Postoperative pain score evaluation in the evening and 24 hours after the operation revealed no significant difference. CONCLUSIONS: The study confirmed significant improvement in quality of life measured by SF-36 questionnaire after both conventional and cryostripping with no difference between the two stripping techniques. Cryostripping results in less bruising than conventional stripping.
RCT Entities:
OBJECTIVES: To assess the improvement in quality of life and complication rates in patients undergoing great saphenous vein (GSV) stripping using two different techniques. DESIGN: A single centre prospective randomised trial. PATIENTS AND METHODS: 160 patients with primary varicose veins and GSV incompetence were randomised to either conventional stripping or cryostripping combined with phlebectomy of varices. Quality of life was assessed as the primary outcome measure prior to surgery and 6 months later, using the SF-36 questionnaire. Operative data, pain score and procedure related complications were evaluated as secondary outcome measures. We assessed the area of bruising and symptoms attributable to saphenous nerve injury. RESULTS: The number of completely analysed patients was 77 in the conventional stripping group and 69 in the cryostripping group. When comparing the preoperative SF-36 scores to the results after 6 months, there was an improvement in all eight domains, which reached statistical significance in six domains in both groups. The mean area of bruising measured in the thigh was significantly greater in the conventional stripping group (161 S.D. 63cm(2) versus 123 S.D. 52cm(2), p=0.010, Student's t test). The number of patients with paraesthesia due to saphenous nerve injury was numerically lower in the cryostripping group at one week [15 (22%), versus 28 (34%), N.S.] but no difference was observed at 6 months. Postoperative pain score evaluation in the evening and 24 hours after the operation revealed no significant difference. CONCLUSIONS: The study confirmed significant improvement in quality of life measured by SF-36 questionnaire after both conventional and cryostripping with no difference between the two stripping techniques. Cryostripping results in less bruising than conventional stripping.