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INTRODUCTION: Non palpable breast tumors are increasingly diagnosed because of screening programs, and their localization during surgery is essential to ensure an adequate resection. Little is known regarding which techniques are used in "real world". MATERIALS AND METHODS: A national web-based survey, with a 21-items questionnaire, was conducted among Breast Centers (BCs) in Italy in 2023. RESULTS: Among 153 BCs, 110 (72 %) participated. Wire-guided localization was reported to be the most used technique, regardless of the volume of malignant tumors treated by each Center (N = 36, 33 %). However, newer techniques such as Radioactive occult lesion localization and magnetic seeds, were reported to be employed in 34 (31 %) BCs, and more often among high-volume BCs (>300 cases/year) (N = 32, 29 % vs. N = 13, 12 %; p = 0.02). Logistic problems of localization were reported to cause delays to the scheduled surgery at least once or in multiple occasions in 26 (24 %) and in 4 (3.5 %) BCs, respectively. Although the majority of BCs declared they were satisfied (N = 48, 44 %) or somewhat satisfied (N = 41, 37 %) with the procedure used in their center, responders stated that they would change their technique, or that they were strongly considering this possibility in 24 (22 %) and in 38 (35 %) cases, respectively. The main barrier to introducing a new technique was associated with procedure costs (90 BCs, 82 %). CONCLUSIONS: There are several critical issues regarding localization techniques at a national level. This should be recognized as a priority because of its impact on both patients and clinical practices.
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BACKGROUND AND PURPOSE: Stroke-associated pneumonia (SAP) affects 10 to 38% of patients in the acute phase of stroke. Stroke patients diagnosed with dysphagia have an 11-fold higher risk of developing SAP. Thus, identifying dysphagic patients through a highly accurate screening tool might be crucial in reducing the incidence of SAP. We present a case-control study designed to evaluate efficacy in reducing the risk of SAP between two swallowing screening tools, the classic water swallow test (WST) and a recently validated tool such as the GLOBE-3S (the Sapienza GLObal Bedside Evaluation of Swallowing after Stroke), which is a highly sensitive swallowing screening tool particularly accurate in detecting silent aspiration as well. METHODS: We analyzed the occurrence of dysphagia in 100 acute stroke patients distributed in two groups: half were screened with WST and the other half with GLOBE-3S. RESULTS: Dysphagia was diagnosed in 28 patients. The main result is that, among patients who passed the dysphagia screenings, none of those screened with the GLOBE-3S method developed pneumonia compared to 31.82% in the WST group. Discriminant function analysis (DFA) showed that NIH Stroke Scale (NIHSS) score and the dysphagia screening method (i.e., GLOBE-3S vs. WST) were the two main factors in the SAP's predicting model and the only significant ones per se. CONCLUSIONS: The new GLOBE-3S screening test can reduce the risk of SAP compared to WST.
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Transtornos de Deglutição , Pneumonia , Acidente Vascular Cerebral , Deglutição , Transtornos de Deglutição/diagnóstico , Transtornos de Deglutição/epidemiologia , Transtornos de Deglutição/etiologia , Humanos , Programas de Rastreamento , Pneumonia/diagnóstico , Pneumonia/epidemiologia , Pneumonia/etiologia , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/diagnósticoRESUMO
OBJECTIVES: REAs from Joint Action (JA1-3) were reviewed and compared versus Health Technology Assessments (HTA) in France, Germany, UK, Italy. METHODS: EUnetHTA REAs published until end of 2019 were identified. Leveraging information derived from the HTA bodies' website key process (population; timing; national HTA bodies involved) and content characteristics (evidence base; comparative therapy, endpoints, subgroups) were determined and compared against national appraisals. RESULTS: All twelve pharmaceutical EUnetHTA assessment finalized until end of 2019 were included with Ustekinumab being the most recent (October 2019) and Pazopanib the first assessment (September 2012). In all but three assessments EUnetHTA's assessment did not cover the full EMA indication. Since JA3 time intervals between EMA approval and EUnetHTA assessment were < 80 days. Number of (co-)authoring HTA bodies ranged between 2 (in 6 REAs) and > 10 (Pazopanib). EUnetHTA did consider non - RCT evidence in 7 procedures; take a rather inclusive approach regarding appropriate comparative treatments; approach endpoints less restrictively than e.g. the German IQWiG/GBA; not apply a predetermined set of subgroups analyses. In seven REAs, national appraisal showed inhomogeneities across the 4 countries. National appraisals for Sotagliflozin and Ustekinumab were not yet available. CONCLUSIONS: A joint European HTA assessment has the potential to address the challenge of heterogeneity across the various national European HTA bodies and to determine joint European clinical development data standards that are aligned with regulatory requirements.
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Preparações Farmacêuticas , Avaliação da Tecnologia Biomédica , Europa (Continente) , França , Alemanha , Humanos , ItáliaRESUMO
AIM: Laparoscopic Hartmann's reversal (HR) is a major abdominal operation that is associated with considerable morbidity and mortality. The robotic approach, with its intrinsic advantages, could potentially overcome the technical complexity of laparoscopy. The aim of this study was to evaluate the short-term results of a series of 24 robotic HR cases. METHOD: The data from 24 patients who underwent robotic HR between September 2016 and July 2019 at two different institutions were prospectively collected and retrospectively analysed. A full robotic single-docking reversal procedure with intracorporeal anastomosis was performed in all patients. RESULTS: The mean age and body mass index of the patients were 69 years and 26 kg/m2 , respectively. Of the patients, 58% were ≥ 70 years old and 42% had comorbidities (mean Charlson Comorbidity Index 3). The mean operating time was 240 min. There were no cases of conversion to the open or laparoscopic approach. No diverting loop ileostomies were constructed. The mean length of hospital stay was 6 days. Minor complications were recorded in three patients. Neither major complications nor 30-day readmissions were registered. CONCLUSIONS: Robotic HR is a feasible and safe procedure. The robotic approach has low rates of major complications and conversion and could potentially increase the number of patients undergoing HR.
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Laparoscopia , Procedimentos Cirúrgicos Robóticos , Anastomose Cirúrgica , Colostomia , Humanos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
INTRODUCTION: Transverse colon cancer (TCC) is poorly studied, and TCC cases are often excluded from large prospective randomized trials because of their complexity and their potentially high complication rate. The best surgical approach for TCC has yet to be established. The aim of this large retrospective multicenter Italian series is to investigate the advantages and disadvantages of both hemicolectomy and transverse colectomy in order to identify the best surgical approach. MATERIALS AND METHODS: This was a retrospective cohort study of patients with mid-transverse colon cancer treated with a segmental colon resection or an extended hemicolectomy (right or left) between 2006 and 2016 in 28 high-volume (more than 70 procedures/year) Italian referral centers for colorectal surgery. RESULTS: The study included 1529 patients, 388 of whom underwent a segmental resection while 1141 underwent an extended resection. A higher number of complications has been reported in the segmental group than in the extended group (30.1% versus 23.6%; p 0.010). In 42 cases the main complication was the anastomotic leak (4.4% versus 2.2%; p 0.020). Recovery outcomes also showed statistical differences: time to first flatus (p 0.014), time to first mobilization (p 0.040), and overall hospital stay (p < 0.001) were significantly shorter in the extended group. Even if overall survival were similar between the groups (95.1% versus 97%; p 0.384), 3-year disease-free survival worsened after segmental resection (78.1% versus 86.2%; p 0.001). CONCLUSIONS: According to our results, an extended right colon resection for TCC seems to be surgically safer and more oncologically valid.
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Fístula Anastomótica/epidemiologia , Colectomia/métodos , Colo Transverso/cirurgia , Neoplasias do Colo/cirurgia , Tempo de Internação/estatística & dados numéricos , Infecção da Ferida Cirúrgica/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Colo Transverso/patologia , Neoplasias do Colo/patologia , Intervalo Livre de Doença , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Taxa de Sobrevida , Fatores de TempoRESUMO
Heterotopic ossification (HO) is a pathological condition characterized by the deposition of mineralized tissue in ectopic locations such as the skeletal muscle. The precise cellular origin and molecular mechanisms underlying HO are still debated. In our study we focus on the differentiation of mesoangioblasts (MABs), a population of multipotent skeletal muscle precursors. High-content screening for small molecules that perturb MAB differentiation decisions identified Idoxuridine (IdU), an antiviral and radiotherapy adjuvant, as a molecule that promotes MAB osteogenic differentiation while inhibiting myogenesis. IdU-dependent osteogenesis does not rely on the canonical BMP-2/SMADs osteogenic pathway. At pro-osteogenic conditions IdU induces a mild DNA Damage Response (DDR) that activates ATM and p38 eventually promoting the phosphorylation of the osteogenesis master regulator RUNX2. By interfering with this pathway IdU-induced osteogenesis is severely impaired. Overall, our study suggests that induction of the DDR promotes osteogenesis in muscle resident MABs thereby offering a new mechanism that may be involved in the ectopic deposition of mineralized tissue in the muscle.
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Diferenciação Celular , Dano ao DNA , Células-Tronco Multipotentes/patologia , Músculo Esquelético/patologia , Osteogênese , Animais , Proteína Morfogenética Óssea 2/metabolismo , Diferenciação Celular/efeitos dos fármacos , Subunidade alfa 1 de Fator de Ligação ao Core/metabolismo , Idoxuridina/farmacologia , Células-Tronco Multipotentes/efeitos dos fármacos , Músculo Esquelético/efeitos dos fármacos , Ossificação Heterotópica , Proteínas Smad/metabolismoRESUMO
BACKGROUND AND PURPOSE: Dysphagia occurs in up to 50% of all patients with acute stroke. There is debate regarding which is the most effective screening tool in identifying aspiration in patients with acute stroke. We assessed the accuracy of the Sapienza Global Bedside Evaluation of Swallowing after Stroke (GLOBE-3S), which combines the Toronto Bedside Swallowing Screening Test (TOR-BSST©) with oxygen desaturation and laryngeal elevation measurement during swallowing. METHODS: We prospectively enrolled consecutive patients with stroke within 72 h of symptom onset. All patients with stroke firstly underwent a standard neurological examination, then the GLOBE-3S evaluation and finally the fiberoptic endoscopic evaluation of swallowing (FEES). Two different assessors, a neurologist and a speech pathologist, blind to both the clinical data and each other's evaluation, administered the GLOBE-3S and FEES examination. We assessed the accuracy of the GLOBE-3S in detecting post-stroke swallow impairment with aspiration using the FEES as the standard. RESULTS: We enrolled 50 patients with acute stroke, 28 of whom (56%) had swallowing impairment with aspiration at FEES evaluation. A total of 33 patients (66%) failed the GLOBE-3S evaluation. The GLOBE-3S reached a sensitivity of 100% and a specificity of 77.3% (negative predictive value, 100%; positive likelihood ratio, 4.34). The median time required for the GLOBE-3S to be performed was 297 s. CONCLUSIONS: GLOBE-3S is quick to perform at the bedside and can accurately identify aspiration in patients with acute stroke. By including the measurement of laryngeal elevation and monitoring of oxygen desaturation, it could represent a highly sensitive instrument to avoid the misdiagnosis of silent aspirators.
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Transtornos de Deglutição/diagnóstico , Deglutição/fisiologia , Acidente Vascular Cerebral/complicações , Idoso , Idoso de 80 Anos ou mais , Transtornos de Deglutição/etiologia , Transtornos de Deglutição/fisiopatologia , Feminino , Humanos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Exame Neurológico , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Healthcare-Associated Infections are a great concern for worldwide healthcare systems and represent a considerable threat to patient safety, leading to adverse clinical outcomes. A defined panel of indicators represents a key element to guide Healthcare Organizations towards identification of main gaps, implementation of effective actions and continuous improvements on Healthcare-Associated Infections prevention and control activities. A review on accreditation systems conducted by the Italian Study Group of Hospital Hygiene of the Italian Society of Hygiene Preventive Medicine and Public Health revealed a substantial heterogeneity of implemented standards and led to the development of a core set of indicators and requirements for Healthcare-Associated Infections' prevention and control within the hospital setting. The main aim of the study was to test the feasibility of the Healthcare-Associated Infections' prevention and control within the hospital setting tool to calculate performance scores on a sample of Italian Healthcare Organizations and to identify major critical issues. The potential benefits of the possibility of future implementation of the tool within Institutional Accreditation Programs is discussed. STUDY DESIGN: Cross sectional pilot survey. METHODS: The Healthcare-Associated Infections' prevention and control within the hospital setting included 96 criteria and 20 key areas including an area for outcomes indicators. For applicable criteria, standards fulfilment was evaluated according to a 4 point Likert scale. A composite score was calculated for each Healthcare Organization and five performance levels were identified. Data were further analysed by computing performance scores at the level of each area and requirement. RESULTS: 20 Healthcare Organizations agreed to take part in this pilot study including two rehabilitative Healthcare Organizations. Among the whole sample a mean of 12.20% of requirements resulted not fulfilled, leaving space for further improvements. Critical areas were easily identified and the instrument was able to capture substantial differences between Healthcare Organizations. Only a few number of standards resulted "Not Applicable" (Mean = 4.71%) and most of them regarded Rehabilitative Healthcare Organizations. Mean composite performance index resulted 74.06% (SD = 16.96, range 36.30 - 94.27%); area of outcome indicators obtained a mean score of 56.17. CONCLUSION: The Healthcare-Associated Infections' prevention and control within the hospital setting resulted an useful tool to assess Healthcare Organizations' performance in the field of Healthcare-Associated Infections prevention and control and to identify necessary actions for further improvements. The distribution of total scores by Healthcare Organizations showed a high heterogeneity. Implementation of the Healthcare-Associated Infections' prevention and control within the hospital setting tool as an institutional accreditation tool may help to drive the required harmonization at a national level of Healthcare-Associated Infections management and control strategies and overcome current substantial regional differences.
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Infecção Hospitalar/prevenção & controle , Atenção à Saúde/normas , Melhoria de Qualidade/normas , Acreditação , Infecções Relacionadas a Cateter/prevenção & controle , Estudos Transversais , Atenção à Saúde/classificação , Atenção à Saúde/estatística & dados numéricos , Estudos de Viabilidade , Humanos , Itália , Projetos Piloto , Infecção da Ferida Cirúrgica/prevenção & controleRESUMO
BACKGROUND: Healthcare-associated infections (HAIs) are an important issue in terms of quality of care. HAIs impact patient safety by contributing to higher rates of preventable mortality and prolonged hospitalizations. In Italy, analysis of the currently available accreditation systems shows a substantial heterogeneity of approaches for the prevention and surveillance of HAIs in hospitals. The aim of the present study is to develop and propose the use of a synthetic assessment tool that could be implemented homogenously throughout the nation. METHODS: An analysis of nine international and of the 21 Italian regional accreditation systems was conducted in order to identify requirements and indicators implemented for HAI prevention and control. Two relevant reviews on this topic were further analyzed to identify additional evidence-based criteria. The project team evaluated all the requirements and indicators with consensus meeting methodology, then those applicable to the Italian context were grouped into a set of "focus areas". RESULTS: The analysis of international systems and Italian regional accreditation manuals led to the identification respectively of 19 and 14 main requirements, with relevant heterogeneity in their application. Additional evidence-based criteria were included from the reviews analysis. From the consensus among the project team members all the standards were compared and 20 different thematic areas were identified, with a total of 96 requirements and indicators for preventing and monitoring HAIs. CONCLUSIONS: The study reveals a great heterogeneity in the definition of accreditation criteria between the Italian regions. The introduction of a uniform, synthetic assessment instrument, based on the review of national and international standards, may serve as a self-assessment tool to evaluate the achievement of a minimum standards set for HAIs prevention and control in healthcare facilities. This may be used as an assessment tool by the Italian institutional accreditation system, also useful to reduce regional disparities.
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Acreditação , Infecção Hospitalar/prevenção & controle , Hospitais/normas , Avaliação de Processos em Cuidados de Saúde , Humanos , ItáliaRESUMO
BACKGROUND: The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. METHODS: Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. RESULTS: A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). CONCLUSION: PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).
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Incontinência Fecal/terapia , Nervo Tibial , Estimulação Elétrica Nervosa Transcutânea/métodos , Idoso , Estimulação Elétrica/efeitos adversos , Estimulação Elétrica/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente , Qualidade de Vida , Método Simples-Cego , Estimulação Elétrica Nervosa Transcutânea/efeitos adversos , Resultado do TratamentoRESUMO
AIM: Recto-urethral fistula (RUF) is a rare complication of radical prostatectomy. We report a transperineal approach using a fibrin sealant haemostatic patch. METHOD: Five consecutive patients who developed RUF following radical prostatectomy had a direct transperineal repair with a haemostatic patch (TachoSil®) and were assessed at a median follow-up of 35.5 (21-45) months. RESULTS: There were no early postoperative complications. The average length of hospital stay was 5 (4-7) days. One patient developed recurrence 4 weeks after removal of the urethral catheter. Following healing in four patients the stoma was reversed at a median interval of 3 months, and 9.5 (7-10) months following the prostatic surgery. In the four patients with successful closure there was no case of recurrence or anorectal or urinary dysfunction at a median follow-up of 35.5 (21-45) months. CONCLUSION: Direct transperineal repair of RUF reinforced with a fibrin haemostatic patch of TachoSil is safe and effective.
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Adesivo Tecidual de Fibrina/administração & dosagem , Hemostáticos/administração & dosagem , Fístula Retal/cirurgia , Doenças Uretrais/cirurgia , Fístula Urinária/cirurgia , Procedimentos Cirúrgicos Urológicos/métodos , Idoso , Seguimentos , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Períneo/cirurgia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Prostatectomia/efeitos adversos , Fístula Retal/etiologia , Resultado do Tratamento , Doenças Uretrais/etiologia , Fístula Urinária/etiologiaRESUMO
Idiopathic pulmonary hemosiderosis (IPH) is a rare cause of alveolar hemorrhage in children but should be considered in children with anemia of unknown origin who develop respiratory complications. It is commonly characterized by the triad of recurrent hemoptysis, diffuse parenchymal infiltrates, and iron-deficiency anemia. Pathogenesis is unclear and diagnosis may be difficult along with a variable clinical course. A 6-year-old boy was admitted to the hospital with a severe iron-deficiency anemia, but he later developed severe acute respiratory failure and hemoptysis requiring intubation and mechanical ventilation. The suspicion of IPH led to the use of immunosuppressive therapy with high dose of corticosteroids with rapid improvement in clinical condition and discharge from hospital.
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We realize a compact two-dimensional tomographic terahertz imaging experiment involving only one photoconductive antenna (PCA) simultaneously serving as a transmitter and receiver of the terahertz radiation. A hollow-core Teflon cylinder filled with α-Lactose monohydrate powder is studied at two terahertz frequencies, far away and at a specific absorption line of the powder. This sample is placed between the antenna and a chopper wheel, which serves as back reflector of the terahertz radiation into the PCA. Amplitude and phase information of the continuous-wave (CW) terahertz radiation are extracted from the measured homodyne self-mixing (HSM) signal after interaction with the cylinder. The influence of refraction is studied by modeling the set-up utilizing ZEMAX and is discussed by means of the measured 1D projections. The tomographic reconstruction by using the Simultaneous Algebraic Reconstruction Technique (SART) allows to identify both object geometry and α-Lactose filling.
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Tuberculosis or TB (tubercle bacillus) remains a major public health problem in developing countries. Over the last decades extrapulmonary locations of the disease have become more frequent due to the increased prevalence of acquired immune deficiency syndrome and the increase number of organ transplants. The urogenital localization represents about 27% of all extra-pulmonary localizations of TB and may be due either to a disseminated infection or to a primitive genitourinary localization. The majority of patients, has pyuria, sometimes with hematuria. The diagnosis of urinary tuberculosis is based on the finding of pyuria in the absence of infection by common bacteria. The initial medical treatment includes isoniazide, rifampicin, pyrazinamide, ethambutol and streptomycin. This disease should be suspected in patients with unexplained urinary tract infections, especially if immunocompromised and/or coming from endemic areas.
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Nefrectomia , Tuberculose Renal/cirurgia , Idoso , Antituberculosos/uso terapêutico , Humanos , Isoniazida/uso terapêutico , Masculino , Nefrectomia/métodos , Fatores de Risco , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Tuberculose Renal/complicações , Tuberculose Renal/diagnóstico por imagem , Tuberculose Renal/tratamento farmacológicoRESUMO
BACKGROUND: The injection of bulking agents into the anal canal has been reported to help patients with fecal incontinence. Although it has been advocated as a safe and effective option, substantial data concerning long-term efficacy are still lacking, and the resorption process of the implants has not yet been carefully studied. The aim of our study was to investigate the long-term outcomes of bulking agents for the treatment of fecal incontinence and the behavior of implanted materials in the anorectum. METHODS: At a median follow-up of 7 years, 19 patients with idiopathic fecal incontinence who had received bulking agent implants were evaluated. Clinical, manometric and ultrasound assessments were carried out. RESULTS: The clinical improvements that were achieved in the short term were not maintained over time. For each patient, the number of implants that could no longer be identified on ultrasound was significantly correlated with poorer clinical long-term outcomes. On average, only 14% of the originally injected volume was still detectable. CONCLUSIONS: In the long term, perianally injected bulking agents seem to lose effectiveness. The ultrasound assessment suggests that the process of resorption is almost complete, and the implants are no longer effective in treating incontinence.
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Incontinência Fecal/tratamento farmacológico , Glucanos/administração & dosagem , Próteses e Implantes , Zircônio/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Canal Anal/diagnóstico por imagem , Materiais Biocompatíveis , Implantes de Medicamento , Incontinência Fecal/diagnóstico por imagem , Feminino , Seguimentos , Glucanos/farmacocinética , Humanos , Masculino , Manometria , Pessoa de Meia-Idade , Resultado do Tratamento , Ultrassonografia , Zircônio/farmacocinéticaRESUMO
We evaluated efficacy of natalizumab in relapsing-remitting multiple sclerosis patients in a clinical practice setting. We report data on the first consecutive 343 patients receiving natalizumab in 12 multiple sclerosis (MS) Italian centers enrolled between April 2007 and November 2010. The main efficacy endpoints were the proportion of patients free from relapses, disease progression, combined clinical activity, defined as presence of relapse or disease progression, from MRI activity, and from any disease activity defined as the absence of any single or combined activity. At the end of follow-up, the cumulative proportion of patients free from relapses was 68%; the proportion of patients free from Expanded Disability Status Scale (EDSS) progression was 93%; the proportion of patients free from combined clinical activity was 65%; the proportion of patients free from MRI activity was 77%; and the proportion of patients free from any disease activity was 53%. Natalizumab was effective in reducing clinical and neuroradiological disease activity. Its effectiveness in clinical practice is higher than that reported in pivotal trials and was maintained over time.
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Anticorpos Monoclonais Humanizados/uso terapêutico , Imunossupressores/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Avaliação da Deficiência , Progressão da Doença , Intervalo Livre de Doença , Feminino , Humanos , Imunossupressores/efeitos adversos , Itália , Estimativa de Kaplan-Meier , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Natalizumab , Vigilância de Produtos Comercializados , Fatores de Tempo , Resultado do TratamentoRESUMO
AIM: Milligan-Morgan hemorrhoidectomy (MM) is still the most common treatment for grades III and IV hemorrhoids despite prolonged post-operative anal pain and wound healing. This multicenter, double blind, randomized, controlled trial was designed to assess the safety and the efficacy of anal wound cleansing with Triclosan (Proctocid®) in the control of symptoms and healing time after MM. METHODS: A total of 113 patients with grades III and IV hemorrhoids, undergoing open hemorroidectomy by diathermy or Ligasure vessel sealing device, were randomly assigned to Triclosan or sodium hypochlorite solution. All patients received analgesics and a fiber-rich diet after hemorrhoidectomy. Postoperative anal pain, bleeding and/or secretion and itch were assessed 7, 14 and 21 days after hemorrhoidectomy by a Visual Analogue Scale (VAS) and the day of complete re-epithelialization of anal wounds was recorded. RESULTS: Fifty-five patients were randomized for Triclosan treatment and 58 for the control drug. The two groups were comparable for demographics, severity of hemorrhoids and technique used for the hemorrhoidectomy. The comparison of days to get complete anal wound healing shows a trend of significance (P=0.05) for the Triclosan group. Bleeding and/or secretion, anal pain and itch were significantly better (P=0.003; P<0.0001 and P=0.01, respectively). CONCLUSION: Triclosan solution for the treatment of post-hemorrhoidectomy wounds is safe and improves the control of post-operative symptoms and wound healing time compared to sodium hypochlorite.