Varicose vein surgery: stripping versus the CHIVA method: a randomized controlled trial. Varicose vein stripping vs haemodynamic correction (CHIVA): a long term randomised trial. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the incompetent greater saphenous vein. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. Varicose veins: optimum compression following sclerotherapy. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. Varicose vein surgery using a pneumatic tourniquet: reduced blood loss and improved cosmesis.
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. To compare the long-term results of stripping vs. haemodynamic correction (Ambulatory Conservative Haemodynamic Management of Varicose Veins, CHIVA) in the treatment of superficial venous incompetence resulting in chronic venous disease (CVD).
                Randomised comparative trial.
                150 patients affected by CVD, CEAP clinical class 2-6, were randomised to saphenous stripping or to CHIVA.
                The clinical outcome was assessed by an independent observer who recorded the Hobbs clinical score for treated limbs. A subjective report of the outcome was provided by the patients. Recurrence of varices was assessed by both clinical examination and duplex ultrasonography.
                The mean follow-up was 10 years, 26 patients were lost to follow-up. The Hobbs score similar in the stripping and CHIVA groups. However recurrence of varicose veins was significantly higher in the stripping group (CHIVA 18%; stripping 35%, P<0.04 Fisher's exact test), without significant differences in the rate of recurrences from the sapheno-femoral junction. The associated risk of recurrence at ten years was doubled in the stripping group (OR 2.2, 95% CI 1-5, P=0.04).
                Recurrent varices occurred more frequently following saphenous stripping than after CHIVA treatment. The deliberate preservation of the saphenous trunk as a route of venous drainage in the CHIVA group may have been a factor reducing the recurrence rate. 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. 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. 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. 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. There is uncertainty regarding the most satisfactory technique of lower limb compression following sclerotherapy for varicose veins. We have compared a standard bandaging technique with a high pressure compression stocking in a randomised trial. Efficacy was judged on the success of injections, complications of the treatment and patient satisfaction. In the stockinged legs 144 of 156 injections were successful, compared with 117 of 147 in the bandaged group (P less than 0.001) (Chi squared). The incidence of superficial thrombophlebitis was also reduced in the stocking group. In addition, the stocking technique costs less in materials than conventional bandaging. We would recommend compression stockings for evaluation in sclerotherapy of varicose veins. The aim of this randomized study was to compare a new method of endovenous saphenous vein obliteration (Closure System, VNUS Medical Technologies, Inc, Sunnyvale, Calif) with the conventional stripping operation in terms of short-term recovery and costs.
                Twenty-eight selected patients for operative treatment of primary greater saphenous vein tributary varicose veins were randomly assigned to endovenous obliteration (n = 15) or stripping operation (n = 13). Postoperative pain was daily assessed during the 1st week and on the 14th postoperative day. The length of sick leave was determined. The RAND-36 health survey was used to assess the patient health-related quality of life. The patient conditions were controlled 7 to 8 weeks after surgery, and patients underwent examination with duplex ultrasonography. The comparison of costs included both direct medical costs and costs resulting from lost of productivity of the patients. Costs that were similar in the study groups were not considered in the analysis.
                All operations were successful, and the complication rates were similar in the two groups. Postoperative average pain was significantly less severe in the endovenous obliteration group as compared with the stripping group (at rest: 0.7, standard deviation [SD] 0.5, versus 1.7, SD 1.3, P =.017; on standing: 1.3, SD 0.7, versus 2.6, SD 1.9, P =.026; on walking: 1.8, SD 0.8, versus 3.0, SD 1.8, P =.036; with t test). The sick leaves were significantly shorter in the endovenous obliteration group (6.5 days, SD 3.3 days, versus 15.6 days, SD 6.0 days; 95% CI, 5.4 to 12.9; P <.001, with t test). Physical function was also restored faster in the endovenous obliteration group. The estimated annual investment costs of the closure operation were US $3360. The other direct medical costs of the Closure operation were about $850, and those of the conventional treatment were $360. With inclusion of the value of the lost working days, the Closure treatment was cost-saving for society, and when 40% of the patients are retired (or 60% of the productivity loss was included), the Closure procedure became cost-saving at a level of 43 operations per year.
                Endovenous obliteration may offer advantages over the conventional stripping operation in terms of reduced postoperative pain, shorter sick leaves, and faster return to normal activities, and it appears to be cost-saving for society, especially among employed patients. Because the procedure is also associated with shorter convalescence, this new method may potentially replace conventional varicose vein surgery. A prospective controlled randomised study has been performed of 100 consecutive patients undergoing varicose vein surgery. One group underwent saphenofemoral flush ligation and multiple lower leg avulsions with the leg exsanguinated with a Rhys-Davies cuff, and ischaemia maintained with a pneumatic tourniquet. The other group underwent identical surgery but with a 30 degree head down tilt only. Blood loss was significantly less (13.5 +/- 12 ml vs 133 +/- 78 ml; P less than 0.01) and postoperative cosmesis was significantly improved in patients in the tourniquet group. Operating time was similar (27 +/- 11 min vs 30 +/- 13 min) in the two groups.
The CHIVA method reduces recurrence of varicose veins and produces fewer side effects than vein stripping. However, we based these conclusions on a small number of trials with a high risk of bias as the effects of surgery could not be concealed. New RCTs are needed to confirm these results and to compare CHIVA with approaches other than open surgery.