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Comparative study of duplex-guided foam sclerotherapy and duplex-guided liquid sclerotherapy for the treatment of superficial venous insufficiency.

PURPOSE: To compare the preliminary results of hemodynamic changes between duplex-guided foam sclerotherapy and duplex-guided liquid sclerotherapy. METHODS: Seventy Seven limbs in 77 patients with isolated greater saphenous vein incompetence were treated with duplex-guided sclerotherapy. Thirty Seven limbs were treated with duplex-guided foam sclerotherapy and the remaining 40 limbs were treated with duplex-guided liquid sclerotherapy. Pretreatment exam was performed using a color duplex scanner and air plethysmography. The sclerosing foam was produced by Tessari's method using 1% and 3% polidocanol. The varicose vein was injected with 2 mL of 1% polidocanol or 1% polidocanol foam, and then 1 mL of 3% polidocanol or 3% polidocanol foam was injected into the greater saphenous vein under duplex guidance. Venous obstruction and recanalization were screened by serial posttreatment duplex examination, and posttreatment air plethysmography analysis was performed 3, 6, 9, and 12 months after the sclerotherapy. RESULTS: Duplex scanning demonstrated complete occlusion in the greater saphenous vein for duplex-guided foam sclerotherapy in 25 limbs (67.6%), which was a significantly higher proportion than for the duplex-guided liquid sclerotherapy (7 limbs, 17.5%, p<0.0001). Recurrent varicose veins were found in 3 patient (8.1%) in the duplex-guided foam sclerotherapy group and 10 (25%) in the duplex-guided liquid sclerotherapy group at 1-year (p=0.048). In duplex-guided foam sclerotherapy, venous filling index values remained normal during the subsequent follow-up examinations, whereas in duplex-guided liquid sclerotherapy, venous filling index began to increase, and there was a significant difference at 6 months between duplex-guided foam sclerotherapy and the duplex-guided liquid sclerotherapy (p<0.0005). At 9 months, there was a significant difference in the residual venous fraction between the two groups, and the residual venous fraction value continued to improve in duplex-guided foam sclerotherapy (p=0.033). CONCLUSIONS: Duplex-guided foam sclerotherapy could have greater promise compared to duplex-guided liquid sclerotherapy in the treatment of superficial venous insufficiency.

Adult↗

Comparison of endoscopic variceal sclerotherapy with sequential endoscopic band ligation plus low-dose sclerotherapy for secondary prophylaxis of variceal hemorrhage: a prospective randomized study.

BACKGROUND: Endoscopic variceal sclerotherapy and band ligation both have certain limitations such as, respectively, esophageal complications and early recurrence of varices. METHODS: From February 1994 to March 1996, all consecutive patients with portal hypertension due to either cirrhosis or noncirrhotic portal fibrosis and a history of variceal bleeding were included in a prospective study and randomly assigned to receive either endoscopic variceal sclerotherapy alone or endoscopic variceal band ligation plus low-dose endoscopic variceal sclerotherapy. RESULTS: Of 69 patients, 34 were randomly assigned to receive endoscopic variceal sclerotherapy alone; 35 received endoscopic variceal band ligation plus endoscopic variceal sclerotherapy. Complete variceal eradication rates (85% vs. 80%) and the number of endoscopic sessions required for eradication (6.61 +/- 2.94 vs. 7.85 +/- 3.31) were similar in the endoscopic variceal sclerotherapy and endoscopic variceal band ligation plus endoscopic variceal sclerotherapy groups, respectively. The mean volume of sclerosant required in the combined group (54.94 +/- 33.74 mL) was significantly less than that in the endoscopic variceal sclerotherapy group (81.91 +/- 34.80 mL). The complication and recurrent bleeding rates were significantly higher in the endoscopic variceal sclerotherapy group than those in the combined group (20% and 16% vs. 3% and 3%, respectively). CONCLUSIONS: Both endoscopic variceal sclerotherapy and endoscopic variceal band ligation plus endoscopic variceal sclerotherapy were comparable in eradicating varices but the combined technique was associated with significantly lower complication and recurrent bleeding rates.

Adult↗

Sclerotherapy plus octreotide versus sclerotherapy alone in the management of gastro-oesophageal variceal hemorrhage.

BACKGROUND: There are different ways for controlling oesophageal variceal bleed which include pharmacological and endoscopic methods. In this study we compare efficacy of octreotide (50 g/hr for 48 hours) combined with sclerotherapy versus sclerotherapy alone in patients with acute bleeding from gastro-oesophageal varices (GOV). METHODS: It was a randomized clinical controlled trial conducted at Aga Khan University Hospital, Karachi, from January 1997 to December 1998. We evaluated the role of octreotide (50 g/hr for 48 hours) combined with sclerotherapy versus sclerotherapy alone in a total of 105 adult cirrhotic patients who had acute bleeding from GOV. Patients were assigned to receive octreotide plus sclerotherapy or sclerotherapy alone. Primary outcome measure was 5-day survival without rebleeding. The hospital stay in days and blood transfusion requirements were also compared in the combined treatment group versus sclerotherapy alone group. RESULTS: Initial control of bleeding was achieved in 46/51 (90.2%) patients who received combined treatment compared to 41/54 (75.9%) patients (p = 0.05) in sclerotherapy alone group. Rebleeding after the first 48 hours was less in the octreotide treated patients 2/46 vs. 8/41 patients (p = 0.003). The octreotide treated patients had a better short term (5 days) survival without rebleeding 44/51 vs. 33/54 (p = 0.003) and shorter hospital stay, 5.31 +/- 3.87 days vs. 6.63 +/- 3.86 (p = 0.008) as compared to sclerotherapy alone group. The blood transfusion requirement was also less in the combined treatment group 3.88 +/- 2.80 vs. 5.37 +/- 3.15 units (p = 0.002). CONCLUSION: 1) The combination of sclerotherapy, and octreotide infusion over 48 hours is more effective than sclerotherapy alone in the treatment of acute variceal bleeding and prevention of early rebleed in cirrhotic patients. 2) It leads to shorter hospital stay and 3) less blood transfusion requirements. 4) Although early survival without rebleeding is improved, the overall mortality at the end of hospitalization period is similar in the two groups of treated patients.

Combined Modality Therapy↗

Combined (short-term plus longterm) sclerotherapy v short-term only sclerotherapy: a randomised prospective trial.

Short term sclerotherapy (by injection(s) around the bleeding point) is used for immediate control of massive haemorrhage from oesophagogastric varices. The usefulness of longterm sclerotherapy once short term sclerotherapy has been successfully carried out was assessed. Two treatment groups were studied: 50 patients were treated by 'combined' (short term followed by longterm) sclerotherapy; 56 patients were treated by short term sclerotherapy only. Patients included in the second group were treated by short term sclerotherapy only if a variceal rebleeding was present. The overall cumulative proportion of patients rebleeding was not significantly different in either group. Combined sclerotherapy patients, however, experienced less episodes of variceal haemorrhage and the source of haemorrhage was different (p < 0.002). Combined sclerotherapy was more efficient in preventing bleeding from oesophageal bleeding points but not those arising from a junctional source (p < 0.05). A greater incidence of oesophageal rebleeding was found in those patients whose first source of bleeding was oesophageal (p < 0.05). No significant difference was detected in survival expectancy between either group. In conclusion, after short term sclerotherapy is carried out successfully, those patients with bleeding from variceal bleeding points located on oesophageal mucosa should benefit most from a longterm sclerotherapy programme.

Esophageal and Gastric Varices↗

Injection sclerotherapy preceded by esophageal tamponade versus immediate sclerotherapy in arresting active variceal bleeding: a prospective randomized trial.

To investigate whether Sengstaken-Blakemore tube tamponade is needed before emergency sclerotherapy, 60 patients with active esophageal variceal bleeding were randomized to receive either immediate injection sclerotherapy (group A) or sclerotherapy preceded by balloon tamponade (group B). Three patients in group A (10%) were completely inaccessible to sclerotherapy. Initial success in stopping bleeding at 24 hours after sclerotherapy was 76% in group A and 81% in group B (p = 0.89). Re-bleeding rate was 27% in group A versus 50% in group B (p = 0.11). Blood requirement was significantly less in group A (3.7 +/- 2.5 units vs. 6.2 +/- 3.2 units, p less than 0.01). Major complications were also significantly less frequently encountered in group A than in group B (14% vs. 39%, p less than 0.05). In-hospital mortality was 24% in group A and 42% in group B (p = 0.14). We conclude that the efficacy of immediate sclerotherapy is comparable to that of delayed sclerotherapy preceded by balloon tamponade. Additionally, significantly less blood requirement and fewer complications were noted in the immediate sclerotherapy group. Thus, emergency sclerotherapy without prior balloon tamponade is feasible and recommended in most patients with acute esophageal variceal hemorrhage.

Balloon Occlusion↗

Sclerotherapy for actively bleeding esophageal varices in male alcoholics with cirrhosis. Veterans Affairs Cooperative Variceal Sclerotherapy Group.

BACKGROUND: Male alcoholics hospitalized with actively bleeding esophageal varices were treated with sclerotherapy or sham sclerotherapy and the outcomes during the index hospitalization were compared. METHODS: The 87 patients were a subset of 253 patients enrolled in a prospective, randomized, single-blind, multicenter, controlled trial conducted in 12 VA medical centers. The patients (44 sclerotherapy, 43 sham therapy) were actively bleeding from esophageal varices at either randomization endoscopy (49) or follow-up endoscopy (38). Events and resource use during the index hospitalization were recorded. RESULTS: In 40 (91%) of the sclerotherapy and 26 (60%) of the sham therapy patients, bleeding was stopped during the endoscopy session (p < 0.001). During the hospitalization, 10 (25%) sclerotherapy and 21 (49%) sham therapy patients died (p = 0.04, relative risk 2.17, 95% CI [1.02, 4.61]); 9 sclerotherapy and 22 sham therapy patients rebled (p = 0.005). The median transfusion requirement was higher for sham therapy (8 vs 4 units, p = 0.001), the number of median ICU hours was greater (101 vs 55, p < 0.001), and more patients in this group required shunt surgery (6 vs 0, p = 0.01). CONCLUSION: Sclerotherapy, compared to no sclerotherapy, stops hemorrhage from actively bleeding esophageal varices and reduces use of resources. Sclerotherapy significantly increased hospital survival.

Alcoholism↗

Physicians' negative perception of sclerotherapy for venous disorders: review of a 7-year experience with modern sclerotherapy.

Sclerotherapy is the injection of a sclerosing substance directly into a varicosity or telangiectasia to cause damage, fibrosis, and eventual obliteration of the vessel. Although sclerotherapy has been shown to be effective with a low incidence of side effects, many physicians in the United States are unaware of the technique or view it in a negative way. To better define the extent of physician unfamiliarity or prejudice toward sclerotherapy, we surveyed a local medical community of gynecologists by anonymous written questionnaire. The results indicated that 82% of the responding physicians believed that their knowledge of sclerotherapy was insufficient to advise their patients, leaving patients to learn about sclerotherapy from mass media sources. Sclerotherapy was perceived as only slightly effective therapy for varicose veins and was thought to have a relatively high incidence of side effects. With recent improvements in the technique, our collaborative experience with 3000 patients receiving 50,000 injections over the past 5 years has shown that sclerotherapy is a safe procedure achieving outstanding cosmetic results with concomitant symptomatic relief of painful varicosities and telangiectases. Sclerotherapy, as practiced today, offers an effective, simple, and less costly alternative to surgical stripping for most varicose and telangiectatic veins. The survey data demonstrate the need to educate the American medical community about the technique and merits of modern sclerotherapy so that patients may be properly guided by their physicians to the best sources of care for their aching and unsightly leg veins.

Adolescent↗

Persistent post-sclerotherapy pigmentation due to minocycline. Three cases and a review of post-sclerotherapy pigmentation.

BACKGROUND: Post-sclerotherapy pigmentation, usually overlying the treated veins and independent of any drug ingestion, is common. This pigmentation is brown and represents haemosiderin and sometimes melanin as well. It usually slowly fades over a period of months, only uncommonly persisting for years. Cutaneous pigmentation due to minocycline ingestion is a known but rare adverse effect. It usually appears as a round or irregular shaped patch that is dark blue to black, representing minocycline moieties and iron complexes. Its persistence for years is common. Clinically and histopathologically, these two causes of pigmentation are quite distinct. In the absence of ulceration, minocycline pigmentation koebnerised by sclerotherapy has not previously been reported. AIMS: To determine the nature of the pigmentation appearing in three patients who had been taking minocycline at the time, or shortly after, they had received sclerotherapy. Clinically, although this pigmentation had the usual distribution observed after sclerotherapy, it was persistent and appeared dark blue to black. RESULTS: The persistent post-sclerotherapy linear pigmentation observed in all three patients had the characteistics of minocycline pigmentation. CONCLUSIONS: This is the first report of such minocycline-aggravated post-sclerotherapy pigmentation. Persistent post-sclerotherapy pigmentation caused by minocycline is a risk associated with ingestion of this drug. Patients need to be warned of this risk because, unlike post-sclerotherapy pigmentation that develops in the absence of drug ingestion, minocycline-aggravated post-sclerotherapy pigmentation may persist for years.

Adult↗

Endoscopic injection sclerotherapy with ligation versus endoscopic injection sclerotherapy alone in the management of esophageal varices: a prospective randomized trial.

BACKGROUND/AIMS: Endoscopic injection sclerotherapy with ligation is a technique by which endoscopic injection sclerotherapy is first carried out for a target esophageal varix using an endoscope equipped with a device for endoscopic variceal ligation, and subsequently, endoscopic variceal ligation is performed for the varix together with the injection site of the sclerosing agent. The aim of this prospective, randomized trial was to compare endoscopic injection sclerotherapy with ligation with endoscopic injection sclerotherapy techniques in utility for patients with esophageal varices. METHODOLOGY: Twenty-four patients with esophageal varices who were to undergo either an elective treatment of bleeding esophageal varices or a prophylactic treatment of non-bleeding esophageal varices underwent endoscopic injection sclerotherapy with ligation (n = 12) or without ligation (n = 12). The patients were followed for a mean of 19.9 +/- 8.1 months in the endoscopic injection sclerotherapy with ligation (EISL) group and 19.5 +/- 5.4 months in the Endoscopic injection sclerotherapy (EIS) group. RESULTS: The red color sign disappeared in 10 patients in the EISL group and 3 in the EIS group (P = 0.004) after initial treatment. The length of time required for initial treatment was 16.3 +/- 4.7 min for the EISL group and 27.2 +/- 6.2 min for the EIS group (P = 0.0003). For treatment-related complications, no significant difference was noted between the 2 groups and no serious complication were noted in the 2 groups. The total quantity of ethanolamine oleate used to attain the endpoint was 17.3 +/- 7.9 mL for the EISL group and 25.2 +/- 9.7 mL for the EIS group (P < 0.05). The cumulative non-relapse rate for 2 years following attainment of the endpoint [F1, RC(-)] was 81.5% for the EISL group and 47.5% for the EIS group, producing no significant difference between the 2 groups. The cumulative non-bleeding and survival rates were 100% in the 2 groups. CONCLUSIONS: Endoscopic injection sclerotherapy with ligation is more useful for esophageal varices than endoscopic injection sclerotherapy alone.

Aged↗

Endoscopic sclerotherapy compared with percutaneous transjugular intrahepatic portosystemic shunt after initial sclerotherapy in patients with acute variceal hemorrhage. A randomized, controlled trial.

BACKGROUND: Hemorrhage from esophageal varices remains a substantial management problem. Endoscopic sclerotherapy was preferred for more than a decade, but fluoroscopically placed intrahepatic portosystemic stents have recently been used with increasing frequency. OBJECTIVE: To compare sclerotherapy with transjugular intrahepatic portosystemic shunt (TIPS) in patients with bleeding from esophageal varices. DESIGN: Randomized, controlled clinical trial. SETTING: Three teaching hospitals. PATIENTS: 49 adults hospitalized with acute variceal hemorrhage from November 1991 to December 1995: 25 assigned to sclerotherapy and 24 assigned to TIPS. INTERVENTION: Patients assigned to repeated sclerotherapy had the procedure weekly. In those assigned to TIPS, an expandable mesh stent was fluoroscopically placed between an intrahepatic portal vein and an adjacent hepatic vein. MEASUREMENTS: Pretreatment measures included demographic and laboratory data. Postrandomization data included index hospitalization survival, duration of follow-up, successful obliteration of varices, rebleeding from varices, number of variceal rebleeding events, total days of hospitalization for variceal bleeding, blood transfusion requirements after randomization, prevalence of encephalopathy, and total health care costs. RESULTS: Mean follow-up (+/-SE) was 567 +/- 104 days in the sclerotherapy group and 575 +/- 109 days in the TIPS group. Varices were obliterated more reliably by TIPS than by sclerotherapy (P < 0.001). Patients having TIPS were significantly less likely to rebleed from esophageal varices than patients receiving sclerotherapy (3 of 24 compared with 12 of 25; P = 0.012). No other follow-up measures differed significantly between groups. A trend toward improved survival, which was not statistically significant, was noted in the TIPS group (hazard ratio, 0.53 [95% CI, 0.18 to 1.5]). CONCLUSIONS: In obliterating varices and reducing rebleeding events from esophageal varies, TIPS was more effective than sclerotherapy. However, TIPS did not decrease morbidity after randomization or improve health care costs. It seemed to produce better survival, but the increase in survival was not statistically significant.

Adult↗

Sclerotherapy for male alcoholic cirrhotic patients who have bled from esophageal varices: results of a randomized, multicenter clinical trial. The Veterans Affairs Cooperative Variceal Sclerotherapy Group.

Sclerotherapy and sham-sclerotherapy were compared in male alcoholic patients with cirrhosis and bleeding esophageal varices. The prospective, single-blind, randomized clinical trial of 5 yr duration entered 253 male alcoholic patients at 12 Veterans Affairs medical centers. Patients were either actively bleeding from esophageal varices at randomization or they had a history of such bleeding. They were treated by endoscopy with sham-sclerotherapy or endoscopy with sclerotherapy at randomization, 4 to 6 days, 9 to 11 days, 1 mo, 3 mo and every 3 mo for 2 yr and followed for the remainder of the study period. Of the patients randomized, 131 were assigned to sham-therapy and 122 were assigned to sclerotherapy. At entry the two patient groups were comparable. The upper gastrointestinal rebleeding rates during the study were 101 and 66 per 100 person years of follow-up in sham-therapy and sclerotherapy, respectively (rate ratio, 1.54; 95% confidence interval, 1.06 to 2.22; p = 0.01). A significantly higher number of episodes were attributable to esophageal varices in the sham-therapy group (112 vs. 52; p = 0.005). Seventy-four sham-therapy patients (56%) and 77 sclerotherapy patients (63%) died (p = 0.54; relative risk, 0.91; 95% confidence interval, 0.66 to 1.25). The mean transfusion requirement was higher in the sham-therapy group (16.0 units vs. 9.4 units; p = 0.002) and more patients in this group required shunt surgery (18 vs. 5; p = 0.005). We conclude that sclerotherapy reduces the rate of rebleeding from varices, the transfusion requirement, and the need for shunt surgery, but has no long-term effect on survival.

Adult↗

Who benefits from endoscopic sclerotherapy of bleeding oesophageal varices? Proposal for differential indications. The Copenhagen Esophageal Varices Sclerotherapy Project.

The value of early sclerotherapy for variceal haemorrhage remains unsettled, possibly because the treatment may be beneficial to some patients and harmful to others. On the basis of a randomized clinical trial of sclerotherapy in 187 patients presenting with their first variceal haemorrhage, we examined the relationship between clinical, endoscopic and biochemical characteristics at admission and the treatment effect on mortality. As previously published, sclerotherapy had no overall effect on the very high mortality during the first 6 weeks (47%), but thereafter the mortality and risk of rebleeding were reduced. The analysis showed that in the 48% of the patients with disturbed consciousness and/or elevated plasma creatinine, sclerotherapy considerably increased short-term mortality, and this was not compensated for by increased long-term survival. Among patients without these characteristics, sclerotherapy reduced mortality in the 25% with ascites, but did not affect short-term mortality in the 27% without. Sclerotherapy significantly improved the long-term survival of these patients. The results suggest that sclerotherapy should not be used in patients with disturbed cerebral or renal function, whereas it may be beneficial in patients without these characteristics.

Adult↗

Endoscopic management for bleeding esophageal varices: sclerotherapy versus sclerotherapy plus band ligation versus band ligation alone. One year experience at a main hospital in Saudi Arabia.

BACKGROUND/AIMS: This study was done retrospectively to compare the outcome of sclerotherapy alone, band ligation alone and band ligation alternating with sclerotherapy in treatment of esophageal varices. METHODOLOGY: During 1 year 30 patients were admitted with variceal bleeding. They received either injection sclerotherapy (8 patients) or band ligation (11 patients), and 11 patients had a combination of both either during first bleed or during follow-up therapy, which is more than 2 sessions in each group. RESULTS: The success rate for stopping first bleeding was 100% in the band ligation and sclerotherapy alone group. The rebleeding rate was 27% in the combination group, 9% in the band ligation group, and none had rebleeding in the sclerotherapy group during follow-up. Eradication of varices was observed in 33% of patients after a second set of sclerotherapy and band ligation. CONCLUSIONS: Our study showed no significant difference between sclerotherapy versus band ligation in stopping initial bleeding or eradication of varices during the follow-up period, but there was a difference in re-bleeding rates among the three groups.

Adolescent↗

[Study of complications after endoscopic sclerotherapy for esophageal varices--particularly 2 cases that changed portal circulation after sclerotherapy].

In 116 patients with esophageal varix due to liver cirrhosis who received the endoscopic sclerotherapy, the following complications were observed after the sclerotherapy: 38 ulcer formation; 19 chest pain; 16 hypotension; 15 fever; 12 pleural effusion; 6 esophageal stenosis and so on. Furthermore, two cases with marked changes of portal circulation were experienced after the sclerotherapy. The first case had severe bleeding out of duodenal varix four months after the sclerotherapy and died because of massive bleeding. The second case had hepatic encephalopathy six months after the sclerotherapy. In both cases, angiography revealed the development of collateral veins after the sclerotherapy. Because the abrupt intercept of the esophageal varix by the successful sclerotherapy causes the increase of the other collateral blood flow, the changes of portal circulation must be watched carefully afterward.

Adult↗

[Comparative study of the effectiveness of thermocoagulation, sclerotherapy and a combination of sclerotherapy and thermocoagulation in the treatment of acute peptic ulcer hemorrhage].

During the 3 years of the trial (June, 1988--December, 1990), 128 patients underwent urgent diagnostic endoscopy and hemostasis for acute peptic-ulcer bleeding. In the first group consisting of 57 patients, hemostasis was carried out by thermocoagulation (heat probe), in the second one (54 patients) by injection sclerotherapy and in the third group, hemorrhage was controlled by a combination of heater probe and sclerotherapy. The first and second groups did not differ significantly in age, sex, hemoglobin values, size, location of an ulcer, and kind of bleeding lesions classified according to Forrest. The efficacy of thermocoagulation and injection sclerotherapy in the treatment of acute peptic-ulcer bleeding was compared. In the group of patients treated with the heater probe, the initial hemostasis was achieved in 56 (98%) patients, while rebleeding occurred in 6 (10.7%) patients. In the sclerotherapy group, the initial hemostasis was accomplished in 51 (94.4%) patients, while 8 (15.6%) patients experienced rebleeding. There was no statistically significant difference in ultimate hemostasis between the patients treated with heater probe (94.7%) and the sclerotherapy patients (88.8%). The incipient results of the treatment of bleeding peptic ulcers obtained by a combination of sclerotherapy and heater probe were extremely good, but the final conclusion will be brought after the research on a larger group of patients. The only patient that died during the treatment belonged to the sclerotherapy group.

Acute Disease↗

A comparison of the simultaneous application of sclerotherapy and rubber band ligation, with sclerotherapy and rubber band ligation applied separately, for the treatment of haemorrhoids: a prospective randomized trial.

OBJECTIVE: To compare simultaneous application of sclerotherapy and rubber band ligation, with sclerotherapy and rubber band ligation applied separately for the treatment of 2nd degree haemorrhoids. PATIENTS AND METHODS: Between 1993 and 1996, 255 patients that suffered from 2nd degree haemorrhoids were divided into 3 groups of 85 patients, each to receive either simultaneous sclerotherapy for smaller and rubber band ligation for larger piles (SCL/RBL) in one session, or sclerotherapy (SCL), or rubber band ligation (RBL), respectively. After a period of 4 years all patients were examined and their symptoms were recorded. RESULTS: The patients of the SCL group developed significantly fewer complications after treatment compared to the other two methods (P < 0.001), which did not differ from each other. After the SCL/RBL treatment, significantly more patients were symptom free (46%) than after SCL (8%), P < 0.001. There was no significant difference between the SCL/RBL (46%) and the RBL (31%) groups (P = 0.217), although the combined treatment seemed to be more effective than rubber band ligation. Only 10% of the patients of the SCL/RBL group needed additional sessions 6-24 months after the initial treatment compared to 30% of the patients of the SCL group (P = 0.001). However, there was no significant difference between SCL/RBL and RBL (17%) groups (P = 0.151). CONCLUSION: The combination of sclerotherapy and rubber band ligation for treatment of 2nd degree haemorrhoids is significantly more efficient than sclerotherapy on its own.

Combined Modality Therapy↗

Endovascular sclerotherapy, surgery, and surgery plus sclerotherapy in superficial venous incompetence: a randomized, 10-year follow-up trial--final results.

The study was planned to evaluate efficacy and costs of endovascular sclerotherapy (ES) in comparison with surgery and surgery associated with sclerotherapy in a prospective (10-year follow-up), good-clinical-practice study. Patients with varicose veins and pure, superficial venous incompetence were included. Of the patients randomized into the three groups 39 (group A) were treated with ES, 40 (B) with surgery + sclerotherapy, and 42 with surgery only (C). Surgery consisted of ligation of the SFJ (saphenofemoral junction) and of incompetent veins detected with color duplex. Of the preselected 150 patients, 121 subjects entered the study; 96 completed the 10-year follow-up (mean age 52.6 +/- 6 years; 51 men, 45 women). Dropouts were due to nonmedical problems. At 10 years no incompetence was observed in subjects treated with SPJ ligation (B and C). In the ES group 18.8% of the SFJs were patent and incompetent and in 43.8% of limbs the distal (below-knee) venous system was still incompetent [16.1% in the surgery + sclerotherapy group (p < 0.05) and 36% in the group treated with surgery only (p < 0.05 vs B and 0.05 vs A)]. Color duplex of the long saphenous vein indicated atrophy or obstruction of a segment (average 6.7 cm) after SFJ ligation (4.2 cm after ES). The cost of ES was 68% of surgery while the cost of surgery and sclerotherapy was 122% of surgery only. Endovascular sclerotherapy is an effective, cheaper treatment option, but surgery after 10 years is superior.

Adult↗

Foam-sclerotherapy, surgery, sclerotherapy, and combined treatment for varicose veins: a 10-year, prospective, randomized, controlled, trial (VEDICO trial).

The study compared, by a prospective, randomized method, 6 treatment options: A: Sclerotherapy; B: High-dose sclerotherapy; C: Multiple ligations; D: Stab avulsion; E: Foam-sclerotherapy; F: Surgery (ligation) followed by sclerotherapy. Results were analyzed 10 years after inclusion and initial treatment. Endpoints of the study were variations in ambulatory venous pressure (AVP), refilling time (RT), presence of duplex-reflux, and number of recurrent or new incompetent venous sites. The number of patients, limbs, and treated venous segments were comparable in the 6 treatment groups, also comparable for age and sex distribution. The occurrence of new varicose veins at 5 years varied from 34% for group F (surgery + sclero) and ligation (C) to 44% for the foam + sclero group (E) and 48% for group A (dose 1 sclero). At 10 years the occurrence of new veins varied from 37% in F to 56% in A. At inclusion AVP was comparable in the different groups. At 10 years the decrease in AVP and the increase in RT (indicating decrease in reflux), was generally comparable in the different groups. Also at 10 years the number of new points of major incompetence was comparable in all treatment groups. These results indicate that, when correctly performed, all treatments may be similarly effective. "Standard," low-dose sclerotherapy appears to be less effective than high-dose sclero and foam-sclerotherapy which may obtain, in selected subjects, results comparable to surgery.

Adult↗