External femoral vein valvuloplasty with limited anterior plication (LAP): a 10-year randomized, follow-up study. Femoral vein valve repair with limited anterior plication (LAP). Comparison of endoscopic ligation and propranolol for the primary prevention of variceal bleeding. Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: a pilot study. Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the incompetent greater saphenous vein. Does surgical correction of the superficial femoral vein valve change the course of varicose disease? Prevention and treatment of postphlebitic syndrome: results of a 3-part study. Improvement of semen and pregnancy rate after ligation and division of the internal spermatic vein: fact or fiction? Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).
The aim of this study was to evaluate the effects after 10 years of external valvuloplasty of the femoral vein (limited anterior plication or LAP). After informed consent patients with venous hypertension due to deep and superficial venous incompetence were randomized into two treatment groups. Both groups were treated with superficial vein surgery (ligation and section of the major incompetent superficial veins). Group 2 was treated with the same procedure and with LAP. External valvuloplasty of the superficial femoral vein was performed with plication of the anterior vein wall after limited dissection of the vein. Results were evaluated with color-duplex scanning and ambulatory venous pressure (AVP) measurements. Endpoints were AVP, refilling time (RT), presence/absence of reflux at the superficial femoral vein, the variation in the diameter of the vein, and quality of life score (QLS). No complications were observed. All femoral veins treated with LAP were competent after 10 years. Significantly lower AVP and longer RT were observed in the LAP group. Also the average diameter of the vein was smaller in the LAP group. Moreover, QLS was significantly better in the LAP group after 10 years. In conclusion, in selected subjects, with moderate deep venous incompetence, functional cusps, or incompetence mainly due to relative enlargement of the femoral vein, LAP may be an effective alternative to external valvuloplasty. Limited anterior plication (LAP) of the incompetent femoral vein was used in 2 groups of subjects with venous hypertension due to deep and superficial venous incompetence. Group 1 subjects were treated only with superficial veins surgery while groups 2 was treated with external valvuloplasty (LAP) at the level of the incompetent femoral vein. The plication was performed at the anterior side of the vein after limited dissection and manipulation. During a two-year follow-up the results of LAP were evaluated with color-duplex and ambulatory venous pressure (AVP) measurements. Nine of the 11 femoral veins treated with LAP were competent after 2 years (in 2 the incompetence was reduced). A lower AVP and RT was found in subjects treated with LAP in comparison with those in Group 1. Also the number of recurrent varicose veins (incompetent venous sites) and the average diameter of the femoral vein were higher in Group 2 (superficial surgery only). As no complications were observed LAP can be considered an alternative to the standard external valvuloplasty in cases of moderate incompetence when valve cusps are present and functional and incompetence is mainly due to relative enlargement of the vein diameter. We compared propranolol therapy and endoscopic ligation for the primary prevention of bleeding from esophageal varices. This prospective, controlled trial included consecutive eligible patients who had large varices (>5 mm in diameter) that were at high risk for bleeding. The patients were assigned to either propranolol therapy, at a dose sufficient to decrease the base-line heart rate by 25 percent, or variceal ligation, to be performed weekly until the varices were obliterated or so reduced in size that it was not possible to continue treatment.
                Of the 89 patients, 82 of whom had cirrhosis of the liver, 44 received propranolol and 45 underwent variceal ligation. The mean (+/-SD) duration of follow-up in each group was 14+/-9 and 13+/-10 months, respectively. The mean time required to achieve an adequate reduction in the heart rate was 2.5+/-1.7 days; the mean number of sessions needed to complete variceal ligation was 3.2+/-1.1. After 18 months, the actuarial probability of bleeding was 43 percent in the propranolol group and 15 percent in the ligation group (P=0.04). Twelve patients in the propranolol group and four in the ligation group had bleeding. Three of the four in the ligation group had bleeding before their varices had been obliterated. Nine patients in the ligation group had recurrent varices, a mean of 3.7 months after the initial treatment. Five patients in each group died; bleeding from the varices was the cause of death of four patients in the propranolol group and of three in the ligation group. There were no serious complications of variceal ligation; in the propranolol group, treatment was stopped in two patients because of side effects.
                In patients with high-risk esophageal varices, endoscopic ligation of the varices is safe and more effective than propranolol for the primary prevention of variceal bleeding. To determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a levonorgestrel-releasing intrauterine device (Lng-IUD) is inserted after operative laparoscopy compared with those treated with surgery only.
                Open-label, parallel-group, randomized, controlled trial.
                A tertiary care and referral center for patients with endometriosis.
                Parous women with moderate or severe dysmenorrhea undergoing first-line operative laparoscopy for symptomatic endometriosis.
                Randomization to immediate Lng-IUD insertion or expectant management after laparoscopic treatment of endometriotic lesions. Proportions of women with recurrence of moderate or severe dysmenorrhea in the two study groups 1 year after surgery and overall degree of satisfaction with treatment. Moderate or severe dysmenorrhea recurred in 2 of 20 (10%) subjects in the postoperative Lng-IUD group and 9/20 (45%) in the surgery-only group. Thus, a medicated device inserted postoperatively will prevent the recurrence of moderate or severe dysmenorrhea in one out of three patients 1 year after surgery. A total of 15/20 (75%) women in the Lng-IUD group and 10/20 (50%) in the expectant management group were satisfied or very satisfied with the treatment received.
                Insertion of an Lng-IUD after laparoscopic surgery for symptomatic endometriosis significantly reduced the medium-term risk of recurrence of moderate or severe dysmenorrhea. 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. We tested the hypothesis that the course of primary chronic venous insufficiency can be changed by correction of the incompetent valve in the superficial femoral vein.
                This was a prospective, randomized, controlled study. A total of 125 extremities with reflux in greater saphenous and superficial femoral veins and belonging to clinical classes C2-C4 were analyzed. During the first 5 years, the type of clinical dynamics and changes in valvular function were determined in each patient. Patients were stratified according to the type of clinical dynamics and randomly assigned to treatment groups. Phlebectomy was performed in all extremities. In each of 64 extremities (the study group), the proximal incompetent superficial femoral vein valve was corrected as a part of the primary intervention. Patients were followed up for 7 to 8 years after surgery.
                The clinical dynamics of the extremity significantly depended on reflux changes. Increase in superficial femoral vein reflux was found in 74% of the extremities with progressive clinical dynamics but in only 47% of extremities with stable clinical dynamics (chi(2) = 9.71; P <.01). After surgical treatment, 65% of the extremities in the control group showed stable improvement; in 11%, recurrent varicosity was found; in 24%, the disease was aggravated. Of the extremities in the study group, 86% had stable improvement, 5% had recurrent varicosity, and 10% were aggravated (P <.05). Extremities with the progressive type of clinical dynamics were main contributors to this difference (chi(2) = 7.86; P <.05). In 92% of the extremities with corrected valves and in 50% of the extremities with increase in reflux after valvuloplasty, clinical improvement was observed (chi(2) = 11.5; P <.01). Extremities with corrected valvular function demonstrated superior results in comparison with extremities with stable valvular function in the control group (clinical improvement in 92% and 66% of extremities, respectively; P <.005).
                In patients with chronic venous insufficiency, two types of clinical dynamics, stable and progressive, can be identified. The progressive type is associated with the presence of superficial femoral vein reflux and increasing greater saphenous vein reflux. Superficial vein surgery neither corrects superficial femoral vein reflux nor prevents it from progressing further. Correction of a single superficial femoral vein valve during primary intervention significantly improves the long-term results of superficial venous surgery. This improvement is associated with the prevention of reflux progression. Surgical correction of the incompetent superficial femoral vein valve changes the course of primary chronic venous insufficiency. The true incidence of postphlebitic syndrome (PPS) following proximal deep venous thrombosis (DVT) and the efficacy of graduated compression stockings in preventing and treating PPS are unknown.
                A 3-part study of 202 patients evaluated 1 year after proximal DVT: 2 randomized placebo-controlled trials of stockings and 1 prospective cohort of untreated patients. Patients were evaluated for PPS, using a standardized questionnaire, and for venous valvular incompetence, using photoplethysmography and venous Doppler. They were enrolled in study 1 or study 2 if they did not have symptomatic PPS and did not have or had venous valvular incompetence, respectively, and into study 3 if they had symptomatic PPS. Study 1 patients were left untreated and followed up for development of PPS every 6 months for a mean of 55 months. Study 2 patients were randomized to a below-knee stocking (20-30 mm Hg) or a matched placebo stocking, and followed up for development of PPS every 6 months for a mean of 57 months. Study 3 patients were randomized to an active stocking (30-40 mm Hg) or a matched placebo stocking and followed up every 3 months for treatment failure, defined a priori.
                In study 1, 6 (5.0%) of 120 patients were categorized as treatment failures, a rate similar to placebo-treated study 2 patients (P =.10). In study 2, 0 (0%) of 24 active and 1 (4.3%) of 23 placebo-treated patients were categorized as treatment failures (P =.49). In study 3, 11 (61.1%) of 18 active and 10 (58.8%) of 17 placebo-treated patients were categorized as treatment failures (P>.99).
                Most patients do not have PPS 1 year after proximal DVT, and do not require stockings. We failed to show a benefit of stockings in patients with PPS, but the small numbers preclude definitive conclusions. Male partners with left-sided varicoceles of 96 infertile couples were studied. Fifty-one patients were submitted to ligation of the testicular veins and 45 individuals were randomised as controls. During an observation period of 53 months (range 36 to 74 months) we found no statiscally significant improvement in the semen crude variables, the morphology or the progressive motility in the series of men submitted to surgery. The pregnancy rate was lower in those who had an excision of varicocelle. 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.
These results indicate that ligation and valvuloplasty may have produced a moderate and sustained improvement for seven to ten years after surgery in patients with mild to moderate DVI caused by primary valvular incompetence. However, there is insufficient evidence to recommend the treatment to this subgroup of patients, as the trials were small, used different methods of valvuloplasty and different methods of assessment.