Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the incompetent greater saphenous vein. Reduction of leg wound infections following coronary artery bypass surgery. Superficial thrombophlebitis of the legs: a randomized, controlled, follow-up study. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). [Experiences with adjuvant prostaglandin therapy in vascular surgery interventions]. Varicose vein surgery: stripping versus the CHIVA method: a randomized controlled trial.
This randomized clinical trial compared early outcomes after radiofrequency ablation (RFA) and conventional surgery for varicose veins.
                Consecutive patients with symptomatic varicose veins due to isolated great saphenous vein (GSV) incompetence and suitable for RFA were randomized to either RFA or conventional surgery (saphenofemoral disconnection and stripping). Clinical, radiological and patient-based outcomes were recorded at 1 and 5 weeks after intervention.
                RFA resulted in successful obliteration of the GSV in all 47 patients. Complete above-knee stripping was unsuccessful in seven of 41 patients. RFA took longer than conventional surgery: median interquartile range 76 (67-84) versus 48 (39-54) min; P < 0.001. Patients returned to their normal activities significantly earlier after RFA (median 3 (2-5) versus 12.5 (4-21) days; P < 0.001). Postoperative pain was significantly less after RFA (median score on visual analogue scale 1.70 (0.50-4.30) versus 4.0 (2.35-6.05); P = 0.001). Patient satisfaction, quality of life improvement and analgesic requirements significantly favoured RFA.
                RFA took longer to perform but resulted in a significantly better early outcome than conventional surgery in suitable patients with great saphenous varicose veins.
                (c) 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. Endovenous laser ablation (EVLA) is a minimally invasive technique for treating varicose veins due to truncal vein incompetence. This randomized trial compared EVLA with conventional surgery in patients with primary saphenofemoral and great saphenous vein (GSV) reflux.
                Consecutive consenting patients with symptomatic varicose veins were randomized to EVLA 1 (stepwise laser withdrawal), EVLA 2 (continuous laser withdrawal) or surgery (saphenofemoral ligation, GSV stripping, multiple phlebectomies). Principal outcome measures were abolition of GSV reflux and improvement in Aberdeen Varicose Vein Symptom Score (AVVSS) 3 months after treatment.
                GSV reflux was abolished in 41 of 42 legs treated with EVLA 1, 26 of 29 following EVLA 2 and 28 of 32 after surgery (P = 0.227). The median (interquartile range, i.q.r.) AVVSS improvement was similar: 9.38 (4.54-14.93) with EVLA 1, 10.26 (5.03-15.03) after EVLA 2 and 8.36 (4.54-13.21) following surgery (P = 0.694). Return to normal activity (median (i.q.r.) 2 (0-7) versus 7 (2-26) days; P = 0.001) and work (4 (2-7) versus 17 (7.25-33.25) days; P = 0.005) was quicker after EVLA by either method.
                Abolition of reflux and improvement in disease-specific quality of life was comparable following both EVLA and surgery. The earlier return to normal activity following EVLA may confer important socioeconomic advantages. Registration number: ISRCTN99270116 (http://www.controlled-trials.com).
                2008 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. Endovenous laser (EVL) ablation of the great saphenous vein (GSV) is thought to minimize postoperative morbidity and reduce work loss compared with high ligation and stripping (HL/S). However, the procedures have not previously been compared in a randomized trial with parallel groups where both treatments were performed in tumescent anesthesia on an out-patient basis.
                Patients with varicose veins due to GSV insufficiency were randomized to either EVL (980 nm) or HL/S in tumescent anesthesia. Miniphlebectomies were also performed. Patients were examined preoperatively and at 12 days, and 1, 3, and 6 months postoperatively. Sick leave, time to normal physical activity, pain score, use of analgesics, Aberdeen score, Medical Outcomes Study Short Form-36 quality-of-life score, Venous Clinical Severity Score (VCSS), and complication rates were investigated. The total cost of the procedures, including lost wages and equipment, was calculated. Cost calculations were based on the standard fee for HL/S with the addition of laser equipment and the standard salary and productivity level in Denmark.
                A follow-up of 6 months was achieved in 121 patients (137 legs). The groups were well matched for patient and GSV characteristics. Two HL/S procedures failed, and three GSVs recanalized in the EVL group. The groups experienced similar improvement in quality-of-life scores and VCSS score at 3 months. Only one patient in the HL/S group had a major complication, a wound infection that was treated successfully with antibiotics. The HL/S and EVL groups did not differ in mean time to resume normal physical activity (7.7 vs 6.9 calendar days) and work (7.6 vs 7.0 calendar days). Postoperative pain and bruising was higher in the HL/S group, but no difference in the use of analgesics was recorded. The total cost of the procedures, including lost wages, was euro 3084 ($3948 US) in the HL/S and euro 3396 ($4347 US) in the EVL group.
                This study suggests that the short-term efficacy and safety of EVL and HL/S are similar. Except for slightly increased postoperative pain and bruising in the HL/S group, no differences were found between the two treatment modalities. The treatments were equally safe and efficient in eliminating GSV reflux, alleviating symptoms and signs of GSV varicosities, and improving quality of life. Long-term outcomes, particularly with respect to recurrence rates, shall be investigated in future studies, including the continuation of the present. This prospective randomized study compared the treatment of greater saphenous vein insufficiency by stripping and local avulsions of varicose veins with high ligation of the saphenofemoral junction (crossectomy) combined with sclerocompression therapy. Of 156 consecutive patients, 89 legs were randomly allocated to stripping and 92 to high ligation. At follow-up of 3 months and 1, 2, and 3 years after treatment, clinical and Doppler ultrasound results, and complaints and cosmetic results, as judged by the patient and the surgeon, were scored. At 3 years, 69 limbs in the stripping group (78%) and 73 limbs in the ligation group (79%) were available to follow-up. The cosmetic results, both judged by the patient and the surgeon, were significantly better (P < 0.05) in the stripped limbs than in the limbs with high ligation and sclerotherapy. Clinical and Doppler ultrasound evidence of reverse flow in the saphenous vein was significantly less (P < 0.001) after the stripping operation. The results of treatment of isolated saphenous vein insufficiency by stripping operation, therefore, were superior to those obtained by high ligation combined with sclerotherapy. To reduce the rate of infection at the saphenous vein harvest site after coronary artery bypass surgery, to identify predictors of infection and to determine the best method for leg wound closure.
                A randomized clinical trial was undertaken to determine the best technique for reducing the postoperative leg wound infection rate. Patients were allocated to one of four leg wound closure methods: staples, close immediately; staples, close after protamine administration; subcuticular sutures, close immediately; and subcuticular sutures, close after protamine. Risk factors evaluated were age, sex, diabetes, obesity, peripheral vascular disease, reoperation, time in surgery, wound length, wound depth, time that the wound was open, wound quality and harvest site.
                The Walter C Mackenzie Health Sciences Centre, University of Alberta, Edmonton, Alberta.
                All consenting patients undergoing elective coronary artery bypass surgery involving saphenous vein harvesting were considered for the study. Exclusion criteria were insertion of a drain, insertion of an intra-aortic balloon pump in the index limb and inability to complete follow-up at the authors' centre. Eighty patients were initially enrolled, with 77 completing the study.
                Patients underwent standard saphenous vein harvesting followed by wound closure as indicated by the study group.
                The major infection rate was reduced from 13% to 3% (P = 0.02). Each closure method was equally effective, and wound depth was the only factor related to infection.
                Leg wound infections continue to be a major source of morbidity after coronary bypass surgery. The aim of the present study was to evaluate the effects of different treatment plans (compression only, early surgery, low-dose subcutaneous heparin [LDSH], low-molecular-weight heparin [LMWH], and oral anticoagulant [OC] treatment) in the management of superficial thrombophlebitis (STP), by considering efficacy and costs in a 6-month, randomized, follow-up trial. Patients with STP, with large varicose veins without any suspected/documented systemic disorder, were included. Criteria for inclusion were as follows: presence of varicose veins; venous incompetence (by duplex); a tender, indurated cord along a superficial vein; and redness and heat in the affected area. All patients were ambulatory. Exclusion criteria were obesity, cardiovascular or neoplastic diseases, bone/joint disease, problems requiring immobilization, and age > 70 years. Patients with superficial thrombophlebitis without varicose veins and patients under treatment with drugs at referral were also excluded. Color duplex (CD) was used to detect concomitant deep vein thrombosis (DVT) and to evaluate the extension or reduction of STP at 3 and 6 months. Venography was not used. Of 562 patients included, 3.5% had had a recent DVT in the same limb affected by SVT and 2.1% in the contralateral limb. In six patients DVT was present in both limbs. These patients were treated with anticoagulants and excluded from the follow-up. After 3 and 6 months the incidence of STP extension was higher in the elastic compression and in the saphenous ligation groups (p < 0.05). There was no significant difference in DVT incidence at 3 months among the treatment groups. Stripping of the affected veins was associated with the lowest incidence of thrombus extension. The cost for compression alone was the lowest and the cost including LMWH was the highest. The average cost was 1,383 US$. However the highest social cost (lost working days, inactivity) was observed in subjects treated only with stockings. This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with temperature-controlled radiofrequency ablation without adjunctive high ligation (Closure procedure).
                Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit.
                Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12; P =.02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (P <.01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (P <.05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months.
                In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping. Two prospective randomized trials were referred. In the first study 50 patients with femorotibial greater saphenous vein in situ bypasses were treated intraarterially with 0.2 ng PGE 1/kg body weight/min and 15,000 i.U. of heparine continuously. The control group of 50 patients also got 15,000 i.U. of heparine and 3 x 0.5 g of Aspirin. We observed 2 (4%) immediate occlusions in the PGE 1 group and 7 (14%) immediate occlusions in the control group. This difference proved to be statistically significant. In the second study 83 patients with three level occlusions (ilio-femoro-tibial) in stage III and IV were treated with a profundaplasty. 42 patients received 60 micrograms PGE 1 in 250 ml saline twice daily. The control group of 41 patients only got twice 250 ml saline over a period of three weeks. In the PGE 1 group 26 patients (61%) showed disappearance of rest pain and healing of necrotic lesions, whereas in the control group this could only be achieved in 15 patients (35%). The difference proved to be statistically significant. The objective of this randomized study was to compare the efficacy of the CHIVA method for the treatment of varicose veins with respect to the standard treatment of stripping.
                Varicose veins are a sign of chronic venous disorder. For over a century, varicose veins have been treated with surgical ablative techniques, with stripping being the standard treatment. Currently, postsurgical varicose veins recurrence (20%-80%) is a common, complex, and costly problem. Ambulatory Conservative Hemodynamic Management of Varicose Veins (CHIVA) is a new option for treating chronic venous disorder.
                In this open-label, randomized controlled trial, 501 adult patients with primary varicose veins were treated in a single center. They were assigned to an experimental group, the CHIVA method (n = 167) and 2 control groups: stripping with clinic marking (n = 167) and stripping with duplex marking (n = 167). The outcome measure was clinical recurrence within 5 years, assessed clinically by previously trained independent observers. Duplex ultrasonography was also used to assess recurrences and causes.
                In an intention-to-treat analysis, clinical outcomes in the CHIVA group were better (44.3% cure, 24.6% improvement, 31.1% failure) than in both the stripping with clinic marking (21.0% cure, 26.3% improvement, 52.7% failure) and stripping with duplex marking (29.3% cure, 22.8% improvement, 47.9% failure) groups. The ordinal odds ratio between the stripping with clinic marking and CHIVA groups, of recurrence at 5 years of follow-up, was 2.64, (95% confidence interval [CI]: 1.76-3.97, P < 0.001). The ordinal odds ratio of recurrence at 5-years of follow-up, between the stripping with duplex marking and CHIVA group, was 2.01 (95% CI: 1.34-3.00, P < 0.001). This trial is registered at ISRCTN and carries the following ID number: ISRCTN52861672, available at: http://isrctn.org.
                The present results indicate that, thanks to specific venous hemodynamic evaluation, the CHIVA method is more effective than stripping with clinical marking or stripping with duplex marking to treat varicose veins. When carrying out a stripping intervention, Duplex marking does not improve the clinical results of this ablative technique.
Currently available clinical trial evidence suggests RFA and EVLT are at least as effective as surgery in the treatment of great saphenous varicose veins. There are insufficient data to comment on USGFS. Further randomised trials are needed. We should aim to report and analyse results in a congruent manner to facilitate future meta-analysis.