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BACKGROUND: Endoscopic rubber band ligation (ERBL) is a nonsurgical technique for the treatment of symptomatic internal hemorrhoids but is limited by recurrence and post-procedural pain. AIM: To evaluate satisfaction, long-term recurrence, and post-procedural pain in managing internal hemorrhoids using a combination of polidocanol foam sclerotherapy and ERBL. METHODS: This was a prospective, multicenter, randomized study. A total of 195 consecutive patients diagnosed with grade II-III internal hemorrhoids were enrolled from four tertiary hospitals and randomly divided into a cap-assisted endoscopic polidocanol foam sclerobanding (EFSB) or an ERBL group. All patients were followed-up for 12 months. Symptom-based severity and post-procedural pain were assessed using a hemorrhoid severity score (HSS) and a visual analog scale (VAS). Continuous variables were reported as medians and interquartile range. RESULTS: One hundred and ninety-five patients were enrolled, with 98 in the EFSB group. HSS was lower in the EFSB group than in the ERBL group at 8 weeks [4.0 (3.0-5.0) vs 5.0 (4.0-6.0), P = 0.003] and 12-month [2.0 (1.0-3.0) vs 3.0 (2.0-3.0), P < 0.001] of follow-up. The prolapse recurrence rate was lower in the EFSB group at 12 months (11.2% vs 21.6%, P = 0.038). Multiple linear regression analysis demonstrated that EFSB treatment [B = -0.915, 95% confidence interval (CI): -1.301 to -0.530, P = 0.001] and rubber band number (B = 0.843, 95%CI: 0.595-1.092, P < 0.001) were negatively and independently associated with the VAS score 24 hours post-procedure. The median VAS was lower in the EFSB group than in the ERBL [2.0 (1.0-3.0) vs 3.0 (2.0-4.0), P < 0.001]. CONCLUSION: Cap-assisted EFSB provided long-term satisfaction and effective relief from the recurrence of prolapse and pain 24 hours post-procedure.
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Hemorroidas , Polidocanol , Recidiva , Soluções Esclerosantes , Escleroterapia , Humanos , Polidocanol/administração & dosagem , Polidocanol/uso terapêutico , Hemorroidas/terapia , Hemorroidas/diagnóstico , Hemorroidas/cirurgia , Pessoa de Meia-Idade , Feminino , Masculino , Estudos Prospectivos , Escleroterapia/métodos , Resultado do Tratamento , Ligadura/métodos , Soluções Esclerosantes/administração & dosagem , Adulto , Idoso , Índice de Gravidade de Doença , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/diagnóstico , Satisfação do Paciente , Medição da Dor , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/uso terapêuticoRESUMO
Background: Although sclerotherapy is widely used to treat vascular malformations (VMs), it is associated with several challenges. One significant issue is the insufficient understanding of the influence of various factors on the stability of polidocanol (POL) foam used in sclerotherapy. Objective: This study aimed to explore the effect of the catheter needle caliber on foam stability when using POL with or without hyaluronic acid (HA) for the treatment of VMs. Methods and materials: The Tessari method generated sclerosant foam using POL both with and without HA. We used catheters and syringe needles of various calibers, and the resulting foam was transferred into new syringes to facilitate a comparison of foam stability. Foam half-life (FHT) was utilized as a metric to assess foam stability. Results: The study found that narrower needle calibers produced a more stable foam when POL was used alone; however, no significant effect was observed when HA was added. Furthermore, when the foam was expelled using catheters and syringe needles of the same size, no noticeable changes in the stability were observed. Conclusion: When choosing needles of varying calibers, their effect on foam stability should be carefully considered, particularly when the foam contains HA.
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BACKGROUND: The foam's structural longevity, linked to the effectiveness of sclerotherapy, depends on preparation conditions. The factors enhancing the treatment's effectiveness and efficacy are still under discussion. METHODS: We conducted an in vitro preclinical research, which included 144 independent trials. A total of 8 combinations involving 18 trials were designed according to settings of +4°C and room temperature (20-22°C), liquid-to-air ratios of 1/1 and 1/4, and polidocanol concentrations of 0.5% and 1% using the modified Tessari method. Our study aimed to examine the effect of air ratio, agent temperature, and polidocanol concentration on stability by assessing the foam half-time (FHT) and defining the optimal preparation conditions. RESULTS: The mean FHT was 117 ± 30.4 s. The longest FHT was in a 1:4 air-to-sclerosant ratio at +4°C, regardless of the sclerosant concentration (for %0.5 mean FHT: 146.2 ± 13.9 s, for % 1 mean FHT: 146.9 ± 18 s). There was a significant interaction among the three variables on FHT (p = 0.001). Temperature emerged as the primary factor (F(1, 136) = 124, p < 0.001, ηp2 = 0.477), with lower temperatures markedly enhancing the longevity (p < 0.001). Preparation at a temperature of 4°C resulted in an extended FHT of 32.5 s compared to 22°C (95% CI: 24.06-41.04 s). CONCLUSION: The temperature, agent concentration, and gas ratio significantly influence the stability of the physician-compounded foam. The low temperature at +4°C may offer better FHT for sclerotherapy.
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Plantar warts are common skin lesions that continue to represent a therapeutic challenge. They are still resistant to therapy and are highly recurrent, despite the diverse number of treatments available. Therapies targeting vasculature, such as pulsed dye laser, have been used successfully in the treatment of plantar warts. Polidocanol, a detergent sclerosant approved for the sclerotherapy of incompetent and dilated saphenous veins, has also been used as an off-label therapy for a wide range of skin conditions with vascular components such as hemangiomas and pyogenic granuloma. The current, open-label, prospective, pilot study aimed to evaluate the safety and efficacy of the intralesional polidocanol 3% in the treatment of plantar warts. Twenty patients (11 females and 9 males), with plantar warts, aged 12-50 years received biweekly sessions of intralesional polidocanol 3% until complete clearance or for a maximum of 6 sessions. Response to treatment was graded as complete (100% clearance), partial (50-99%), and no response (< 50%). At the end of the study, 12 (60%) patients achieved complete clearance of their warts after 1-5 sessions, 5 (25%) patients had only partial response, and 3 (15%) patients did not achieve any clearance of their warts. The procedure was largely tolerable by patients. Pain at the injection site and bruises were reported by 9 (45%) and 2 (10%) patients, respectively. Both side effects resolved spontaneously and completely within a few days. The findings of the current study suggest that intralesional injection of 3% polidocanol in biweekly sessions may be a safe, effective, and tolerable method for the treatment of plantar warts.
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Injeções Intralesionais , Polidocanol , Soluções Esclerosantes , Escleroterapia , Verrugas , Humanos , Polidocanol/administração & dosagem , Projetos Piloto , Feminino , Masculino , Adulto , Escleroterapia/métodos , Escleroterapia/efeitos adversos , Verrugas/terapia , Verrugas/tratamento farmacológico , Adolescente , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem , Soluções Esclerosantes/administração & dosagem , Soluções Esclerosantes/efeitos adversos , Estudos Prospectivos , CriançaRESUMO
OBJECTIVE: We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence via network meta-analysis of published comparative evidence. METHODS: We conducted a systematic literature review following best practices, including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized and nonrandomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis. RESULTS: We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates. CONCLUSIONS: Polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.
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The present aimed to examine the effectiveness of polidocanol-based foam sclerotherapy for oral venous malformations (OVMs). The present study performed a retrospective analysis of patients with OVMs who underwent sclerotherapy using polidocanol. Patients achieving the complete resolution of OVM were categorized as having a complete response (CR), those with a reduction in size from the initial diagnosis were categorized as having a partial response (PR), those with no change in size as stable disease (SD), and those with an increase in size as progressive disease (PD). A total of 16 patients, comprising 4 males and 12 females, underwent treatment with polidocanol foam therapy, covering 22 affected areas. The treatment administered resulted in CR in 6 cases and PR in 10 cases, with no instances of SD or PD. Apart from localized injection site pain or swelling, there were no severe side-effects reported, such as circulatory dynamic changes or skin necrosis. On the whole, these findings underscore the effectiveness of foam sclerotherapy with polidocanol as a viable treatment for venous malformations in the oral and maxillofacial regions.
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BACKGROUND AND OBJECTIVE: Lower limb varicose veins are a prevalent disease associated with several available treatment options, including conventional surgery and polidocanol foam sclerotherapy. However, few studies have analyzed therapeutic modality outcomes based on Patient-Reported Outcome Measures (PROMs). This large sample-size study was designed to evaluate the outcomes of polidocanol foam sclerotherapy compared to conventional surgery based on an analysis of PROMs. METHODS: This was a prospective, observational, and qualitative study of 205 patients who underwent varicose vein treatment with either polidocanol foam sclerotherapy (57 patients, 90 legs) or conventional surgery (148 patients, 236 legs). Patients were preoperatively assessed and re-evaluated 30 days after the procedure using the Venous Disease Severity Score (VCSS) and specific venous disease quality-of-life questionnaires (VEINES-QoL/Sym). RESULTS: Both treatments significantly improved VCSS and VEINES results 30 days after the procedure (p < 0.05). However, surgery promoted greater improvements in VCSS (on average 4.02-points improvement, p < 0.001), VEINES-QoL (average 8-points improvement, p < 0.001), and VEINES-Sym (average 11.66 points improvement, p < 0.001) than did sclerotherapy. Postoperative pain and aesthetic concerns about the legs were the domains of the questionnaires in which the results varied the most between the treatment modalities, with worse results for sclerotherapy. CONCLUSION: Both polidocanol foam sclerotherapy and conventional surgery positively impact patients' quality of life after 30 days, but the improvement is more significant for patients who undergo conventional surgery.
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Qualidade de Vida , Varizes , Humanos , Polidocanol , Polietilenoglicóis , Estudos Prospectivos , Veia Safena , Soluções Esclerosantes/uso terapêutico , Soluções Esclerosantes/efeitos adversos , Escleroterapia/efeitos adversos , Resultado do Tratamento , Varizes/cirurgia , Varizes/terapiaRESUMO
BACKGROUND: Polidocanol endovenous microfoam (PEM) has been used to treat lower extremity venous reflux for almost one decade with specific advantages for below knee (BK) truncal veins where thermal ablation poses a risk of injury to adjacent nerves. The current literature of the BK segment often examines short-term outcomes with modest sample sizes. We aim to identify factors associated with recanalization and reintervention in this subset of patients. METHODS: We performed a retrospective study of a prospectively maintained database of patients from a single institution who underwent 1% PEM ablation for BK great saphenous vein (GSV) and small saphenous vein (SSV) reflux. Patients underwent duplex ultrasound (DU) within 7 days after injection, every 3 to 6 months for 1 year, and every 6 to 12 months thereafter. Patients with symptomatic recanalization underwent reintervention. The 26 patients lost to follow-up without DU after ablation were excluded. The factors associated with recanalization and reintervention were examined by multivariate and nonparametric analyses. RESULTS: Between March 2018 and July 2023, 411 patients (166 male, 245 female) with 573 treated limbs (284 right, 289 left) met the study criteria. Of the 573 included limbs, 457 (79.8%) had undergone prior above knee saphenous ablations. A total of 554 BK GSV and 42 SSV ablations were performed. The most recent DU was performed at a mean of 231 ± 329 days. The overall recanalization rate was 10.6% (55 GSVs and 8 SSVs) at a mean follow-up of 104 ± 180 days. Comparing the closed and recanalized veins, we found no significant difference in age (P = .90), treated laterality (P = .14), patient body mass index (P = .59), preprocedural CEAP (clinical-etiology-anatomy-pathophysiology) score (P = .79), recanalization rate in GSVs vs SSVs (P = .06), or administered PEM volume (P = .24). The recanalized veins had significantly larger preprocedural diameters than the veins that remained closed (recanalized, 4.9 mm; closed, 4.3 mm; P = .001). Men had higher incidence of recanalization than women (men, 14.2%; women, 8%; P = .015). Anticoagulation use was associated with recanalization (odds ratio, 1.96; 95% confidence interval, 1.1-3.6; P = .03). Early recanalization at the first DU accounted for 31 failures (49.2%) and had a significantly lower administered PEM volume compared with later recanalization (early, 4 mL; late, 5 mL; P = .025). There were no significant differences between the 33 recanalized patients requiring reintervention (52.4%) and the 30 who did not. Twenty-four reinterventions were performed with PEM, 100% of which remained closed at a median of 160 days (interquartile range, 257 days). CONCLUSIONS: PEM is successful for the treatment of BK GSV and SSV reflux with a closure rate of 89% at a mean of 231 days and shows promise as salvage therapy. Most cases of recanalization were noted in the early postprocedure period and were associated with a lower PEM volume. A larger vein diameter, male sex, and anticoagulation use are associated with higher rates of recanalization.
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OBJECTIVE: To assess the influence of varying retention doses of ultrasound-guided polidocanol chemical ablation for benign cystic-solid thyroid nodules. METHODS: A retrospective study was conducted from December 2019 to January 2022, including 78 patients with benign cystic-solid thyroid nodules, of which 31 received polidocanol chemical ablation alone, 23 received polidocanol chemical plus thermal ablation, and 24 received open surgery. Patients who received polidocanol chemical ablation were assigned into groups based on the retention dose of polidocanol: 0 %, 10 %, 20 %, 30 %, and 50 %. Follow-ups were done at 1, 3, 6, and 12 months postoperatively. The volume of the nodules, postoperative complications, and recurrence of the nodules were examined before treatment and during follow-up visits. RESULTS: Total operation time and intraoperative bleeding volume for patients who received ablation were substantially lower than those for patients who received open surgery (P < 0.001). Among patients in the polidocanol chemical ablation group, volume shrinkage rate of thyroid nodules in the 10 % retention dose group was significantly lower than that in the 0 % retention dose group at 1, 3, and 6 months postoperatively (P < 0.05). The 30 % retention dose group had the highest nodule shrinkage rate (98.46 ± 1.55 %) at 12 months postoperatively, which was significantly higher than that in the 50 % retention dose group (P < 0.05). Among patients in the polidocanol chemical and thermal ablation group, the volume shrinkage rate of thyroid nodules in the 10 % and 30 % retention dose groups at 1 month postoperatively was significantly lower than that in the 0 % retention dose group (P < 0.05). Although volume shrinkage rate in the 20 % retention dose group after thermal ablation was higher than that in the 0 % retention dose group, the difference was not statistically significant (P > 0.05). In terms of adverse reactions, the incidence of hoarseness and coughing was higher in the open surgery group than in the polidocanol chemical ablation and polidocanol chemical and thermal ablation groups, but there was no significant difference (P > 0.05). CONCLUSION: Chemical ablation with polidocanol was safe and effective for therapy of benign cystic-solid thyroid nodules, and the optimal retention dose may be between 20 % and 30 %. Patients with poor efficacy from chemical ablation alone can receive safe and effective treatment through thermal ablation.
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Polidocanol , Soluções Esclerosantes , Nódulo da Glândula Tireoide , Ultrassonografia de Intervenção , Humanos , Polidocanol/administração & dosagem , Feminino , Masculino , Estudos Retrospectivos , Nódulo da Glândula Tireoide/diagnóstico por imagem , Nódulo da Glândula Tireoide/cirurgia , Nódulo da Glândula Tireoide/patologia , Pessoa de Meia-Idade , Adulto , Resultado do Tratamento , Soluções Esclerosantes/administração & dosagem , Técnicas de Ablação/métodos , IdosoRESUMO
OBJECTIVE: Telangiectasias, characterized by dilated venules, are frequently observed in the lower extremities. Sclerotherapy stands out as the predominant treatment of these vascular lesions. The integration of laser therapy with a mild sclerosing agent, serving as an osmotic sclerosant, presents an enhanced cosmetic treatment approach, aiming to optimize outcomes and minimize potential adverse effects. This study sought to evaluate the feasibility, efficacy, and safety of cryo-laser and cryo-sclerotherapy (CLaCS) and compare it with injection sclerotherapy for the treatment of telangiectasia and reticular veins. METHODS: In this randomized controlled trial, individuals expressing concerns about telangiectasia and reticular veins were recruited for aesthetic treatment. The enrolled patients were prospectively randomized according to the chosen treatment technique. Group A included patients undergoing CLaCS with 70% dextrose, focusing on a single area measuring 20 cm by 20 cm. Group B included patients receiving polidocanol injection sclerotherapy for a single area of the same dimensions. RESULTS: Group A comprised 195 patients and group B comprised 197 patients. The rates of complete lesion elimination after the first, second, and third treatment sessions were 64.6%, 86.2%, and 100% in group A and 50.3%, 74.1%, and 85.3% in group B, respectively. Group A exhibited a significantly higher complete elimination rate compared with group B at the conclusion of the study (P < .001). Furthermore, group A demonstrated a statistically significant lower incidence of postprocedural pigmentation and other complications compared with group B (P < .001). These findings underscore the enhanced efficacy and safety profile associated with the CLaCS technique using 70% dextrose compared with injection sclerotherapy with polidocanol. CONCLUSIONS: CLaCS, combining cryo-laser and cryo-sclerotherapy, demonstrated superior efficacy and safety compared with traditional polidocanol sclerotherapy for treating telangiectasia and reticular veins.
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Polidocanol , Soluções Esclerosantes , Escleroterapia , Telangiectasia , Humanos , Telangiectasia/terapia , Escleroterapia/efeitos adversos , Escleroterapia/métodos , Feminino , Masculino , Soluções Esclerosantes/administração & dosagem , Soluções Esclerosantes/efeitos adversos , Adulto , Polidocanol/administração & dosagem , Polidocanol/uso terapêutico , Pessoa de Meia-Idade , Resultado do Tratamento , Estudos Prospectivos , Criocirurgia/efeitos adversos , Polietilenoglicóis/administração & dosagem , Glucose/administração & dosagem , Veias/diagnóstico por imagem , Estudos de Viabilidade , Terapia a Laser/efeitos adversos , Adulto Jovem , Idoso , Fatores de TempoRESUMO
Injection sclerotherapy is an effective and safe treatment in selected cases. It might be used as the first treatment for I-III degree hemorrhoidal disease (HD), but also as a bridge therapy for more severe cases not amenable to invasive treatments. However, concerning the long-term recurrence rate, open excisional hemorrhoidectomy remains the gold standard in cases of III- and IV-degree HD. In this context, it is recommended to perform the excision of no more than three piles and to preserve the muco-cutaneous bridges to avoid post-operative anal stenosis. The aim of this study is to evaluate surgical outcomes and efficacy of the combined treatment of open excisional hemorrhoidectomy and the use of ST on the remnant muco-cutaneous bridges/residual piles. This was a single-center retrospective study and a total of 18 patients with IV-degree HD, aged between 18 and 75 years with symptomatic HD according to the Goligher classification, were enrolled between January 2023 and June 2023 and their follow-up continued until October 2023 after reaching 3 months of follow-up. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey Incontinence Score were used to assess symptoms and their impact on quality of life and continence. A total of 77.8% (14/18) of the patients were symptom-free (hemorrhoidal disease symptom score (HDSS) score = 0) after 3 months. Moreover, a statistically significant decrease in the median HDSS and short health scale for HD (SHS-HD) score was registered from 16 preoperatively (T0) to 2 at 3-month follow-up (T3). Neither post-operative bleeding nor any type of complications occurred. The use of sclerotherapy in combination with the traditional open excisional hemorrhoidectomy has shown promising results. Further structured studies are needed and greater dissemination and education of the general surgeon on the subject is necessary.
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BACKGROUND: This systematic review and meta-analysis aimed to evaluate the safety and efficacy of sclerotherapy methods for hemorrhoidal disease (HD) over the past 40 years. METHODS: The review followed the 2020 Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A comprehensive literature search was conducted, including studies reporting the use of sclerotherapy in patients with HD. Study eligibility criteria were defined, and data were extracted independently by the authors. Random-effects meta-analyses were performed to assess outcomes of interest. RESULTS: Out of 1965 records identified, 44 studies met the inclusion criteria, involving 9729 patients. The majority of studies were conducted in Japan, followed by the UK, Italy, and Portugal. The median age of participants was 52 years, and the majority were male. The Goligher grade distribution indicated varying degrees of HD severity. Sclerotherapy was predominantly administered through anoscopy, with polidocanol being the most commonly used agent. The procedure was generally performed without pre-injection analgesia. The meta-analysis of 14 randomized controlled trials (RCTs) revealed that sclerotherapy was not inferior to control interventions in terms of success rate (risk ratio [RR] 1.00, 95% CI 0.71-1.41) and recurrence rate (RR 1.11, 95% CI 0.69-1.77), while resulting in fewer complications (RR 0.46, 95% CI 0.23-0.92). CONCLUSIONS: This systematic review highlights the safety and efficacy of sclerotherapy for HD, which yields similar success rates and fewer complications compared to other conservative or surgical approaches. Further research is warranted to optimize sclerotherapy techniques and evaluate long-term outcomes. REGISTRATION: PROSPERO 2023 CRD42023396910.
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Hemorroidas , Escleroterapia , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Escleroterapia/efeitos adversos , Hemorroidas/terapia , Itália , Razão de Chances , PolidocanolRESUMO
OBJECTIVE: To evaluate the safety and efficacy of bleomycin polidocanol foam (BPF) sclerotherapy for venous malformations (VMs) and analyze the associated clinical outcomes and predictors. METHODS: We retrospectively assessed BPF sclerotherapy outcomes in 138 patients with VMs. We analyzed pain levels, lesion volume reduction, and subjective perception of response. Logistic regression analysis was performed to identify potential predictors of treatment outcome. Additionally, we carefully monitored and recorded complications. RESULTS: There was a notable average reduction in lesion volume by 78.50% ± 15.71%. The pain numerical rating scale (NRS) score decreased from 4.17 ± 2.63 prior to treatment to 1.05 ± 1.54 afterward, and 70.3% of the patients experienced effective relief after a single BPF treatment. Multivariate analysis revealed that a high baseline NRS (odds ratio [OR]: 4.026) and elevated activated partial thromboplastin time (APTT, OR: 1.200) were positive predictors of pain reduction. Additionally, a high baseline NRS score (OR: 1.992) and elevated thrombocytocrit (PCT, OR: 2.543) were positive predictors of incomplete postoperative pain relief. Minor complications occurred in 31 (22.46%) patients. CONCLUSION: BPF sclerotherapy is safe and effective for VMs, resulting in significant reduction in lesion volume, improved symptoms, and minimal complications. APTT and PCT levels are important predictors of pain outcomes following BPF treatment.
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Bleomicina , Polietilenoglicóis , Escleroterapia , Humanos , Bleomicina/uso terapêutico , Polidocanol , Estudos Retrospectivos , Dor/etiologiaRESUMO
OBJECTIVE: The objective of this study was to retrospectively evaluate the effectiveness of polidocanol in managing pain, swelling, functional limiting and cosmetic disorders in patients with venous malformations (VMs). METHODS: This retrospective study included patients who underwent sclerotherapy with polidocanol for VMs between 2020 and 2022. Patient records, imaging findings, and evaluation questionnaires used in the preprocedure and follow-up phases were reviewed. After sclerotherapy, patients were followed up at 1, 2, 3, and 6 months. During these visits, the previously used 11-point verbal numerical rating scale (from 0 [no pain] to 10 [worst pain thinkable]) was used to evaluate the severity of symptoms such as pain, swelling, cosmetic discomfort, and functional limitation, and patients were asked to report the number of days per week they experienced these symptoms owing to the VM. RESULTS: A total of 194 sclerotherapy procedures (mean, 1.6 ± 0.3 procedures) in 84 patients (55 female and 29 male patients; mean age, 22.45 ± 11.83 years) were conducted. The majority of these malformations (81%, or 68 patients) were located in the extremities. We found a significant decrease in pain, swelling, functional limitation, cosmetic appearance, and number of painful days between all time points, except for the comparison between months 3 and 6 (P < .001) CONCLUSIONS: Polidocanol sclerotherapy is a safe and effective treatment for VMs that significantly decreases patient complaints and has a very low complication rate. Particularly, following patients at short intervals and administering additional sclerotherapy sessions when necessary will significantly increase patient satisfaction.
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Polietilenoglicóis , Escleroterapia , Malformações Vasculares , Humanos , Masculino , Feminino , Criança , Adolescente , Adulto Jovem , Adulto , Polidocanol/efeitos adversos , Escleroterapia/efeitos adversos , Escleroterapia/métodos , Estudos Retrospectivos , Soluções Esclerosantes/efeitos adversos , Malformações Vasculares/diagnóstico por imagem , Malformações Vasculares/terapia , Malformações Vasculares/complicações , Resultado do Tratamento , Dor/etiologiaRESUMO
OBJECTIVE: This study aims to investigate the difference in safety and efficacy between two treatments for venous malformations (VMs), electrochemotherapy combined with polidocanol foam (ECP) and bleomycin polidocanol foam (BPF), providing alternative therapies for VMs. METHODS: We conducted a retrospective review of 152 patients with VMs treated with ECP and BPF. Pre- and post-treatment magnetic resonance images (MRIs) were collected, and clinical follow-up assessments were performed. Imaging results were used to calculate lesion volume changes. Clinical outcomes included changes in pain and improvements in perceived swelling. Patients were followed up at 1 week and 6 months after surgery. All emerging complications were documented in detail. RESULTS: Of the 152 patients, 87 (57.2%) received BPF treatment, and 65 (42.8%) received ECP treatment. The most common location of VMs was the lower extremities (92/152; 60.2%), and the most common symptom was pain (108/152; 71.1%). Forty-three patients had previously undergone therapy in the BPF group (43/87; 49.4%), whereas 30 patients had received prior treatment in the ECP group (30/65; 46.2%). The study found that the percentage of lesion volume reduction in the BPF group was not significantly different from that in the ECP group (75.00% ± 17.85% vs 74.69% ± 8.48%; P = .899). ECP was more effective when the initial lesion volume was greater than 30 mL (67.66% ± 12.34% vs 73.47% ± 8.00%; P = .048). Patients treated with BPF had significantly less posttreatment pain than those treated with ECP, in different baseline lesion size. In the overall sample, pain relief was significantly higher in the BPF group than in the ECP group (4.21 ± 1.19 vs 3.57 ± 0.76; P = .002). However, there was no difference in pain relief between the two groups for the treatment of initially large VMs (4.20 ± 0.94 vs 3.70 ± 0.87; P = .113). The ECP group was significantly more likely to develop hyperpigmentation (5/87; 5.75% vs 11/65; 16.92%; P = .026) and swelling (9/87; 10.34% vs 16/65; 24.62%; P = .019) 1 week after surgery than the BPF group. CONCLUSIONS: Our study demonstrates that both BPF and ECP are effective treatments for VMs, with BPF being a safer option. ECP is a better choice for patients with the initial lesion volume greater than 30 mL, but it is more likely to lead to early swelling and hyperpigmentation.
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Eletroquimioterapia , Hiperpigmentação , Polietilenoglicóis , Malformações Vasculares , Humanos , Polidocanol/efeitos adversos , Soluções Esclerosantes , Bleomicina/efeitos adversos , Escleroterapia/efeitos adversos , Escleroterapia/métodos , Eletroquimioterapia/efeitos adversos , Malformações Vasculares/diagnóstico por imagem , Malformações Vasculares/terapia , Malformações Vasculares/complicações , Resultado do Tratamento , Dor/etiologia , Estudos Retrospectivos , Hiperpigmentação/etiologiaRESUMO
Abstract Background and objective: Lower limb varicose veins are a prevalent disease associated with several available treatment options, including conventional surgery and polidocanol foam sclerotherapy. However, few studies have analyzed therapeutic modality outcomes based on Patient-Reported Outcome Measures (PROMs). This large sample-size study was designed to evaluate the outcomes of polidocanol foam sclerotherapy compared to conventional surgery based on an analysis of PROMs. Methods: This was a prospective, observational, and qualitative study of 205 patients who underwent varicose vein treatment with either polidocanol foam sclerotherapy (57 patients, 90 legs) or conventional surgery (148 patients, 236 legs). Patients were preoperatively assessed and re-evaluated 30 days after the procedure using the Venous Disease Severity Score (VCSS) and specific venous disease quality-of-life questionnaires (VEINES-QoL/Sym). Results: Both treatments significantly improved VCSS and VEINES results 30 days after the procedure (p < 0.05). However, surgery promoted greater improvements in VCSS (on average 4.02-points improvement, p < 0.001), VEINES-QoL (average 8-points improvement, p < 0.001), and VEINES-Sym (average 11.66 points improvement, p < 0.001) than did sclerotherapy. Postoperative pain and aesthetic concerns about the legs were the domains of the questionnaires in which the results varied the most between the treatment modalities, with worse results for sclerotherapy. Conclusion: Both polidocanol foam sclerotherapy and conventional surgery positively impact patients' quality of life after 30 days, but the improvement is more significant for patients who undergo conventional surgery.
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BACKGROUND: Percutaneous treatment for primary aneurysmal bone cysts (ABCs) has been widely accepted. The study aimed to evaluate the efficacy of various sclerotherapy agents on patients with primary ABCs. METHODS: A meta-analysis of relevant studies. A systematic search was conducted on five databases, resulting in the inclusion of 25 studies with different percutaneous agents. RESULTS: A total of 729 patients with primary ABCs were included. Patients were administered with Ethibloc, doxycycline, embolization, alcohol, polidocanol, and calcitonin with methylprednisolone, respectively. Overall, 542 (74.3%) patients with ABCs had complete healing, 120 (16.4%) had partial healing, 44 (6%) had no-ossification or failure, and 26 (3.5%) had a recurrence. However, there was a total of 45 (6.1%) patients who had surgical curettage after sclerotherapy. Among the sclerotherapy agents, doxycycline showed highly effective results with minimal complications and recurrence, but it required multiple injections per patient. Ethibloc and embolization also proved to be highly effective with fewer injections required but had a higher rate of complications. Absolute alcohol, polidocanol, and calcitonin with methylprednisolone had similar efficacity and favorable success with fewer complications and fewer injections. CONCLUSION: Percutaneous treatment showed promising results in treating primary ABCs. However, more robust research is needed to establish the best approach for sclerotherapy in clinical practice and to address the limitations of the current literature.
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Introduction: Polidocanol sclerotherapy in the treatment of aneurysmal bone cysts (ABCs) with or without pathological fractures has been a topic of debate. While some studies recommend intralesional curettage as the preferred treatment, others suggest intralesional sclerosants as an effective alternative. Material and methods: This study evaluates the use of polidocanol-based percutaneous sclerosant therapy in 28 patients with ABCs, of which 8 patients had pathological fracture. The patients received injections every four weeks based on clinical and radiological evaluation of the cyst, and the study assessed the results and complications of the treatment. Results: In group A (without pathological fractures), 14 out of 17 (82.4 %) lesions healed without any significant residual lesion. Three out of 17 (17.6 %) patients required further surgical intervention and were treated by curettage and bone grafting, definitively. Minor local inflammatory reaction was observed in 3 patients, which resolved without intervention within 3-4 days. In group B, all the 8 patients (100 %) with pathological fracture in their lesions healed as Grade 1 healing, without any significant residual lesion. One patient developed an episode of anesthesia related complication (delayed recovery) which resolved within an hour, without any residual effect. At final follow up, no recurrence was seen in any patient. Conclusion: The study concludes that polidocanol sclerotherapy is an effective treatment option for patients with ABCs, with or without pathological fractures, and has the potential to become the new treatment of choice for pathological fractures due to its low invasiveness, low morbidity, and affordability. However, further research is needed to confirm the efficacy of polidocanol sclerotherapy in larger patient populations and to compare its effectiveness with other treatment options.
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Venous malformations are a vascular disorder. Currently, the use of chemical sclerosing agents is a common clinical approach for the treatment of venous malformations. However, the effectiveness of existing sclerosing agents is unsatisfactory and often accompanied by severe side effects. In this study, we have developed a novel cationic surfactant-based sclerosing agent (POL-TA) by conjugating the plasmin inhibitor tranexamic acid (TA) with a nonionic surfactant polidocanol (POL) through an ester bond. POL-TA induces endothelial cell damage, triggering the coagulation cascade and thrombus formation. Moreover, it releases TA in vivo, which inhibits plasmin activity and the activation of matrix metalloproteinase (MMPs), thereby stabilizing the fibrin network of the thrombus and promoting vascular fibrosis. We have established a cell model using venous malformation endothelial cells and assessed the cellular damage and underlying mechanisms of POL-TA. The inhibitory effects of POL-TA on the plasmin-MMPs system were evaluated using MMP-9 activity assay kit. Additionally, the mice tail vein model was employed to investigate the vascular sclerosing effects and mechanisms of POL-TA.
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BACKGROUND: Aneurysmal bone cysts (ABC) are benign cystic bone tumors of an osteolytic and locally aggressive nature. As an alternative to the primary treatment of choice, which consists of curettage with bone grafting, alternative treatment methods with promising results have been described. At our department, we have, in recent years, used percutaneous sclerotherapy with polidocanol. The objective of this study was to identify the healing rate and safety of sclerotherapy with polidocanol. AIM: To identify the efficacy and safety of sclerotherapy with polidocanol in primary and recurrent ABC. METHODS: Twenty-two consecutive patients (median age 12.5 years; range 1-27) with 23 ABCs treated with sclerotherapy with polidocanol from 2016-2021 were included retrospectively. Eleven patients (48%) had undergone different forms of previous treatment with recurrence. Under general anesthesia and fluoroscopic guidance, repeated percutaneous injections of 4mg polidocanol/kg body weight were performed. Through review of the electronic medical records, the following were identified: healing and recurrence rate, number of treatments, gender, age, comorbidity, location of the tumor and side effects / complications, as well as any previous surgery for ABC. The median length of radiographic follow-up was 19.5 mo. RESULTS: All ABCs except one (96%) showed healing or stable disease after a median of 4 (range 1-8) injections. Complete clinical and radiographic healing was observed in 16 cysts (70%), while partial radiographic healing with resolution of pain was seen in 6 cases (26%) and considered as stable disease. The cyst that failed to heal had previously undergone curettage twice with recurrence. One patient with a large pelvic ABC experienced, right after two injections, a sudden drop in blood pressure, which could quickly be reversed. One patient with a juxtaphyseal ABC in the femoral neck showed a minor limb length discrepancy because of deformity. Beyond that, no complications were observed. CONCLUSION: Percutaneous sclerotherapy with polidocanol appears to be a safe alternative for treatment of aneurysmal bone cysts. In our series of both primary and recurrent cysts, it showed the ability to achieve healing or stable disease in 22 of 23 cases (96%). Further studies are needed to decide if this provides a long-lasting effect.