OBJECTIVE: The aim of this study was to evaluate whether great saphenous vein (GSV) surgery without high ligation of the saphenofemoral junction (SFJ) is beneficial in terms of varicose vein recurrence. METHODS: This was a prospective randomized trial set in a private practice. From December 2000 to May 2004, 120 patients were enrolled. Patients were randomly allocated preoperatively to two groups undergoing GSV surgery with (group A, n = 60) or without (group B, n = 60) high ligation of the SFJ. In four patients (two in each group), both limbs were operated on. Inclusion criteria were primary varicose veins with SFJ incompetence resulting in GSV reflux. Exclusion criteria were age <18 years, inability to give informed consent, associated small saphenous vein incompetence, and prior GSV surgery. Mean follow-up was 8 years and was complete in all but one patient (99.2%). The primary end point was varicose vein recurrence, defined as treated lower limbs with new thigh varices at clinical evaluation (CEAP ≥ 2) or venous reflux at the thigh or groin level, as assessed by duplex ultrasound imaging. RESULTS: The follow-up included 123 limbs. The combined clinical and ultrasound-determined recurrence rate was 24.4% (30 of 123): 32.2% (20 of 62) in group A vs 16.4% (10 of 61) in group B (P = .045). Postoperatively, recurrence of even minimal varices was observed in 24 limbs (19.5%): 18 of 62 (29.0%) in group A vs six of 61 (9.8%) in group B (P = .014). The ultrasound-detected recurrence rate was 22% (27 of 123): 32.2% (20 of 62) in group A vs 11.4% (7 of 61) in group B (P = .010). The average time to recurrence was 3.5 ± 1.2 years in group A and 4.1 ± 1.6 years in group B (P = .258). CONCLUSIONS:GSV surgery without high ligation of the SFJ is associated with low rates of clinical and ultrasound-determined recurrence of varicose veins.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate whether great saphenous vein (GSV) surgery without high ligation of the saphenofemoral junction (SFJ) is beneficial in terms of varicose vein recurrence. METHODS: This was a prospective randomized trial set in a private practice. From December 2000 to May 2004, 120 patients were enrolled. Patients were randomly allocated preoperatively to two groups undergoing GSV surgery with (group A, n = 60) or without (group B, n = 60) high ligation of the SFJ. In four patients (two in each group), both limbs were operated on. Inclusion criteria were primary varicose veins with SFJ incompetence resulting in GSV reflux. Exclusion criteria were age <18 years, inability to give informed consent, associated small saphenous vein incompetence, and prior GSV surgery. Mean follow-up was 8 years and was complete in all but one patient (99.2%). The primary end point was varicose vein recurrence, defined as treated lower limbs with new thigh varices at clinical evaluation (CEAP ≥ 2) or venous reflux at the thigh or groin level, as assessed by duplex ultrasound imaging. RESULTS: The follow-up included 123 limbs. The combined clinical and ultrasound-determined recurrence rate was 24.4% (30 of 123): 32.2% (20 of 62) in group A vs 16.4% (10 of 61) in group B (P = .045). Postoperatively, recurrence of even minimal varices was observed in 24 limbs (19.5%): 18 of 62 (29.0%) in group A vs six of 61 (9.8%) in group B (P = .014). The ultrasound-detected recurrence rate was 22% (27 of 123): 32.2% (20 of 62) in group A vs 11.4% (7 of 61) in group B (P = .010). The average time to recurrence was 3.5 ± 1.2 years in group A and 4.1 ± 1.6 years in group B (P = .258). CONCLUSIONS: GSV surgery without high ligation of the SFJ is associated with low rates of clinical and ultrasound-determined recurrence of varicose veins.