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The evolution of laparoscopic right hemicolectomy, particularly with complete mesocolic excision (CME) and central vascular ligation (CVL), represents a significant advancement in colon cancer surgery. The CoDIG 1 and CoDIG 2 studies highlighted Italy's progressive approach, providing useful findings for optimizing patient outcomes and procedural efficiency. Within this context, accurately predicting postoperative length of stay (LoS) is crucial for improving resource allocation and patient care, yet its determination through machine learning techniques (MLTs) remains underexplored. This study aimed to harness MLTs to forecast the LoS for patients undergoing right hemicolectomy for colon cancer, using data from the CoDIG 1 (1224 patients) and CoDIG 2 (788 patients) studies. Multiple MLT algorithms, including random forest (RF) and support vector machine (SVM), were trained to predict LoS, with CoDIG 1 data used for internal validation and CoDIG 2 data for external validation. The RF algorithm showed a strong internal validation performance, achieving the best performances and a 0.92 ROC in predicting long-term stays (more than 5 days). External validation using the SVM model demonstrated 75% ROC values. Factors such as fast-track protocols, anastomosis, and drainage emerged as key predictors of LoS. Integrating MLTs into predicting postoperative LOS in colon cancer surgery offers a promising avenue for personalized patient care and improved surgical management. Using intraoperative features in the algorithm enables the profiling of a patient's stay based on the planned intervention. This issue is important for tailoring postoperative care to individual patients and for hospitals to effectively plan and manage long-term stays for more critical procedures.
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Background: Uncertainty and inconsistency in terminology regarding the risk factors (RFs) for in-hospital falls are present in the literature. Objective: (1) To perform a literature review to identify the fall RFs among hospitalized adults; (2) to link the found RFs to the corresponding categories of international health classifications to reduce the heterogeneity of their definitions; (3) to perform a meta-analysis on the risk categories to identify the significant RFs; (4) to refine the final list of significant categories to avoid redundancies. Methods: Four databases were investigated. We included observational studies assessing patients who had experienced in-hospital falls. Two independent reviewers performed the inclusion and extrapolation process and evaluated the methodological quality of the included studies. RFs were grouped into categories according to three health classifications (ICF, ICD-10, and ATC). Meta-analyses were performed to obtain an overall pooled odds ratio for each RF. Finally, protective RFs or redundant RFs across different classifications were excluded. Results: Thirty-six articles were included in the meta-analysis. One thousand one hundred and eleven RFs were identified; 616 were linked to ICF classification, 450 to ICD-10, and 260 to ATC. The meta-analyses and subsequent refinement of the categories yielded 53 significant RFs. Overall, the initial number of RFs was reduced by about 21 times. Conclusion: We identified 53 significant RF categories for in-hospital falls. These results provide proof of concept of the feasibility and validity of the proposed methodology. The list of significant RFs can be used as a template to build more accurate measurement instruments to predict in-hospital falls.
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Accidentes por Caídas , Prueba de Estudio Conceptual , Accidentes por Caídas/estadística & datos numéricos , Humanos , Factores de Riesgo , Hospitalización/estadística & datos numéricosRESUMEN
BACKGROUND: Type 2 Diabetes Mellitus (T2DM) presents a significant healthcare challenge, with considerable economic ramifications. While blood glucose management and long-term metabolic target setting for home care and outpatient treatment follow established procedures, the approach for short-term targets during hospitalization varies due to a lack of clinical consensus. Our study aims to elucidate the impact of pre-hospitalization and intra-hospitalization glycemic indexes on in-hospital survival rates in individuals with T2DM, addressing this notable gap in the current literature. METHODS: In this pilot study involving 120 hospitalized diabetic patients, we used advanced machine learning and classical statistical methods to identify variables for predicting hospitalization outcomes. We first developed a 30-day mortality risk classifier leveraging AdaBoost-FAS, a state-of-the-art ensemble machine learning method for tabular data. We then analyzed the feature relevance to identify the key predictive variables among the glycemic and routine clinical variables the model bases its predictions on. Next, we conducted detailed statistical analyses to shed light on the relationship between such variables and mortality risk. Finally, based on such analyses, we introduced a novel index, the ratio of intra-hospital glycemic variability to pre-hospitalization glycemic mean, to better characterize and stratify the diabetic population. RESULTS: Our findings underscore the importance of personalized approaches to glycemic management during hospitalization. The introduced index, alongside advanced predictive modeling, provides valuable insights for optimizing patient care. In particular, together with in-hospital glycemic variability, it is able to discriminate between patients with higher and lower mortality rates, highlighting the importance of tightly controlling not only pre-hospital but also in-hospital glycemic levels. CONCLUSIONS: Despite the pilot nature and modest sample size, this study marks the beginning of exploration into personalized glycemic control for hospitalized patients with T2DM. Pre-hospital blood glucose levels and related variables derived from it can serve as biomarkers for all-cause mortality during hospitalization.
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Biomarcadores , Glucemia , Diabetes Mellitus Tipo 2 , Mortalidad Hospitalaria , Aprendizaje Automático , Valor Predictivo de las Pruebas , Humanos , Proyectos Piloto , Glucemia/metabolismo , Diabetes Mellitus Tipo 2/mortalidad , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/diagnóstico , Biomarcadores/sangre , Masculino , Anciano , Femenino , Persona de Mediana Edad , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Causas de Muerte , Pronóstico , Control Glucémico/mortalidad , HospitalizaciónRESUMEN
BACKGROUND: Botulinum toxin is an effective therapeutic option for chronic anal fissure. However, there is no evidence about treatment standardization and long-term follow-up. We aimed to evaluate the short- and long-term efficacy and safety of botulinum toxin compared to close lateral internal sphincterotomy, with a 5-year follow-up. METHODS: This was a prospective, controlled, single-center study conducted at University Hospital of Ferrara, Ferrara, Italy. The primary outcome was fissure healing at 1 month. Secondary outcomes were Quality-of-Life (QoL) at 1 month and after 5 years, and fissure recurrence at 6 months and 5 years. RESULTS: A total of 59 patients received botulinum toxin injection (Botox), and 32 underwent lateral internal sphincterotomy. At 1 month after treatments, postoperative pain decreased faster and significantly more in the Botox group (30 vs. 60 mm; P<0.001); fissure re-epithelization was observed in 59.4% of the surgical group compared to 25.4% of Botox (P=0.0001). Anal sphincter pressures decreased more in surgical group (P=0.044), although severe anal incontinence was present only in this subset (6.2%; P=0.041). Compared to surgery, patients who received Botox had higher satisfaction rates (P<0.001). Fissure recurrence at 6 months was more common in Botox than surgical group (16.9% vs. 3.2%, respectively; P=0.053). The overall healing rate improved in all patients and persisted at 12 months and 5 years in both groups with overall high patient satisfaction despite mild anal incontinence in 21.8% in the surgery group (P<0.05). CONCLUSIONS: Botox, rather than surgery, should be considered the first-line treatment for chronic anal fissure.
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Toxinas Botulínicas Tipo A , Fisura Anal , Humanos , Fisura Anal/tratamiento farmacológico , Fisura Anal/cirugía , Estudios Prospectivos , Femenino , Masculino , Enfermedad Crónica , Toxinas Botulínicas Tipo A/administración & dosificación , Toxinas Botulínicas Tipo A/uso terapéutico , Persona de Mediana Edad , Estudios de Seguimiento , Adulto , Resultado del Tratamiento , Calidad de Vida , Fármacos Neuromusculares/uso terapéutico , Fármacos Neuromusculares/administración & dosificación , Recurrencia , Esfinterotomía Lateral Interna , Factores de Tiempo , Canal Anal/cirugíaRESUMEN
AIMS: To assess the extent of off-label drug use and the occurrence of suspected adverse drug reactions (ADRs) among paediatric patients in Italian hospitals. METHODS: We conducted a 2-year prospective cohort study across 22 Italian hospital wards from September 2020 to September 2022. As part of the surveillance project, we performed a 6-month retrieval of all reported ADRs and evaluated all drug prescriptions for their possible off-label use. Following an educational project on pharmacovigilance addressed to healthcare professionals in participating wards, the same data collection was performed. RESULTS: Among the 892 patients included in the study, 64% were admitted to paediatric wards and 36% to neonatal wards. Fifty per cent of all drugs prescribed were used off-label and mainly concerned the administration of a different dose from the one authorized. In neonatal wards, off-label prescriptions occurred slightly more often, with antibacterials being the most frequently used off-label drugs. A total of 35 reports of suspected ADRs were collected, five before the educational project and 30 afterwards. Based on product licence, 10 of the total 35 reports concerned at least one off-label drug use. CONCLUSIONS: The off-label use of drugs in treating paediatric patients was extensive in Italian hospitals. Regulatory interventions are needed to promote the use of drugs based on the latest available literature and improve ADR reporting on children. Paediatric indications and dosages of the drugs most commonly used in children should be supported by appropriate ad hoc studies.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Trastornos Relacionados con Sustancias , Recién Nacido , Niño , Humanos , Uso Fuera de lo Indicado , Estudios Prospectivos , Preparaciones Farmacéuticas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Hospitales , Sistemas de Registro de Reacción Adversa a Medicamentos , Italia/epidemiologíaRESUMEN
Novel antidiabetic drugs have the ability to produce anti-inflammatory effects regardless of their glucose-lowering action. For this reason, these molecules (including GLP-1 RAs and DPP-4is) were hypothesized to be effective against COVID-19, which is characterized by cytokines hyperactivity and multiorgan inflammation. The aim of our work is to explore the potential protective role of GLP-1 RAs and DPP-4is in COVID-19 (with the disease intended to be a model of an acute stressor) and non-COVID-19 patients over a two-year observation period. Retrospective and one-versus-one analyses were conducted to assess the impact of antidiabetic drugs on the need for hospitalization (in both COVID-19- and non-COVID-19-related cases), in-hospital mortality, and two-year mortality. Logistic regression analyses were conducted to identify the variables associated with these outcomes. Additionally, log-rank tests were used to plot survival curves for each group of subjects, based on their antidiabetic treatment. The performed analyses revealed that despite similar hospitalization rates, subjects undergoing home therapy with GLP-1 RAs exhibited significantly lower mortality rates, even over a two-year period. These individuals demonstrated improved survival estimates both within hospital and non-hospital settings, even during a longer observation period.
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BACKGROUND: The incidence of synchronous multiple primary lung cancer (SMPLC) has progressively increased, due to recent advances in imaging. To date, no guidelines defining recommendations for patients' selection and no standard treatment of cases with SMPLC have been defined.The primary aim of this systematic review was to assess survival among patients treated with lobectomy or sublobar resection MPLC. METHODS: Comprehensive literature search of Medline, the Cochrane Library, reference lists, and ongoing studies was performed according to a prospectively registered design (PROSPERO: CRD42019115487). All studies published between 1998 and December 2020 that examined treatments with lobectomy compared to sublobar resection were included. Two double-blind investigators independently selected articles.Primary outcomes were to assess the 5-year overall survival (OS) rate among patients treated with lobectomy or sublobar resection and the impact of lymph node status on 5-year OS and 5-year disease-free survival in patients with MPLC. RESULTS: The search yielded 424 articles; 4 observational studies met the inclusion criteria and collectively evaluated 298 patients with a mean age ranging from 61.5 to 67 years. A total of 112 patients were treated for bilateral synchronous tumors and 186 patients for unilateral multiple synchronous tumors. All included studies showed that the type of resection, lobectomy or limited resection, had no significant impact on survival. CONCLUSION: Limited resection is a valuable treatment option for MPLC. However, the clinical level of evidence of the studies found is low and randomized studies are needed to clarify the extent of resection in MPLC.
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Neoplasias Pulmonares , Neoplasias Primarias Múltiples , Humanos , Persona de Mediana Edad , Anciano , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/cirugía , Resultado del Tratamiento , Estadificación de Neoplasias , Neumonectomía , Neoplasias Primarias Múltiples/diagnóstico por imagen , Neoplasias Primarias Múltiples/cirugía , Neoplasias Primarias Múltiples/etiología , Estudios Retrospectivos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Objective. There are limited data for estimating the risk of early discharge following thoracoscopic lobectomy. The objective was to identify the factors associated with a short length of stay and verify the influence of these variables in uncomplicated patients. Methods. We reviewed all lobectomies reported to the Italian VATS Group between January 2014 and January 2020. Patients and perioperative characteristics were divided into two subgroups based on whether or not they met the target duration of stay (≤ or >4 days). The association between preoperative and intraoperative variables and postoperative length of stay (LOS) ≤4 days was assessed using a stepwise multivariable logistic regression analysis to identify factors independently associated with LOS and factors related to LOS in uncomplicated cases. Results. Among 10,240 cases who underwent thoracoscopic lobectomy, 37.6% had a hospital stay ≤4 days. Variables associated with LOS included age, hospital surgical volume, Diffusion Lung CO % (81 [69−94] vs. 85 [73−98]), Forced Expiratory Volume (FEV1) % (92 [79−106] vs. 96 [82−109]), operative time (180 [141−230] vs. 160 [125−195]), uniportal approach (571 [9%] vs. 713 [18.5%]), bioenergy sealer use, and pain control through intercostal block or opioids (p < 0.001). Except for FEV1 and blood loss, all other factors emerged significantly associated with LOS when the analysis was limited to uncomplicated patients. Conclusions. Demographic, clinical, and surgical variables are associated with early discharge after thoracoscopic lobectomy. This study indicates that these characteristics are associated with early discharge. This result can be used in association with clinical judgment to identify appropriate patients for fast-track protocols.
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BACKGROUND: Coronavirus Disease 2019 (COVID-19) became a significant challenge for the work and personal experience of physiotherapists (PTs). OBJECTIVE: To investigate how the work activities of PTs in a region in Italy have changed, describe the reasons for change, perceived competence, and effectiveness of professional education, and explore their personal experience. METHODS: We adopted a monocentric convergent mixed-methods light-questionnaire variant study. The questionnaire contains both closed-ended and open-ended questions. Quantitative and qualitative data were combined to interpret the results. RESULTS: Among 78 respondents (response rate 24.4%), 87.2% worked during the pandemic, 52.9% treated patients with COVID-19, and 45.6% changed their working activities. Professional competence was perceived as low in intensive and sub-intensive care settings. The major critical aspect of professional education was respiratory rehabilitation. Life-learning education was judged as effective, even if mainly focused on safety. Nine themes emerged from the analysis of the PTs' experiences: 1) Physiotherapy during COVID-19; 2) Fear and negative feelings; 3) Positive aspects; 4) Organization and management; 5) Prevention measures; 6) Patients; 7) Change; 8) Information; and 9) Professional education. CONCLUSIONS: PTs who have direct experience with patients with COVID-19 showed great resilience. They overcame the first phase of disorientation and fear, despite a specific lack of competence in the respiratory field.
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[18F]F-FDG (FDG) PET is emerging as a relevant diagnostic and prognostic tool in neuroendocrine neoplasms (NENs), as a simultaneous decrease in [68Ga]Ga-DOTA peptides and increase in FDG uptake (the "flip-flop" phenomenon) occurs during the natural history of these tumors. The aim of this study was to evaluate the variations on FDG PET in NEN patients treated with two different schemes of radioligand therapy (RLT) and to correlate them with clinical−pathologic variables. A prospective evaluation of 108 lesions in 56 patients (33 males and 23 females; median age, 64.5 years) affected by NENs of various primary origins (28 pancreatic, 13 gastrointestinal, 9 bronchial, 6 unknown primary (CUP-NENs) and 1 pheochromocytoma) and grades (median Ki-67 = 9%) was performed. The patients were treated with RLT within the phase II clinical trial FENET-2016 (CTID: NCT04790708). RLT was offered for 32 patients with the MONO scheme (five cycles of [177Lu]Lu-DOTATOC) and for 24 with the DUO scheme (three cycles of [177Lu]Lu-DOTATOC alternated with two cycles of [90Y]Y-DOTATOC). Variations in terms of the ΔSUVmax of a maximum of three target lesions per patient (58 for MONO and 50 for DUO RLT) were assessed between baseline and 3 months post-RLT FDG PET. In patients with negative baseline FDG PET, the three most relevant lesions on [68Ga]Ga-DOTA-peptide PET were assessed and matched on post-RLT FDG PET, to check for any possible changes in FDG avidity. Thirty-five patients (62.5%) had at least one pathological FDG uptake at the baseline scans, but the number was reduced to 29 (52%) after RLT. In the patients treated with DUO-scheme RLT, 20 out of 50 lesions were FDG positive before therapy, whereas only 14 were confirmed after RLT (p = 0.03). Moreover, none of the 30 FDG-negative lesions showed an increased FDG uptake after RLT. The lesions of patients with pancreatic and CUP-NENs treated with the DUO scheme demonstrated a significant reduction in ΔSUVmax in comparison to those treated with MONO RLT (p = 0.03 and p = 0.04, respectively). Moreover, we found a mild positive correlation between the grading and ΔSUVmax in patients treated with the MONO scheme (r = 0.39, p < 0.02), while no evidence was detected for patients treated with the DUO scheme. Our results suggest that RLT, mostly with the DUO scheme, could be effective in changing NEN lesions' glycometabolism, in particular, in patients affected by pancreatic and CUP-NENs, regardless of their Ki-67 index. Probably, associating [90Y]Y-labelled peptides, which have high energy emission and a crossfire effect, and [177Lu]Lu ones, characterized by a longer half-life and a safer profile for organs at risk, might represent a valid option in FDG-positive NENs addressed to RLT. Further studies are needed to validate our preliminary findings. In our opinion, FDG PET/CT should represent a potent tool for fully assessing a patient's disease characteristics, both before and after RLT.
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Background: Constipation and faecal incontinence are not so uncommon in patients with multiple sclerosis, impairing quality of life. The gut microbiota is altered in multiple sclerosis patients and likely contributes to disease pathogenesis. Trans-anal irrigation has been proven to allow treatment of neurogenic bowel dysfunction and may affect gut microbiota. Objectives: The primary outcome was trans-anal irrigation effectiveness on constipation and faecal incontinence. The secondary outcome was gut microbiota profiling compared to healthy subjects and during trans-anal irrigation adoption. Methods: We conducted a prospective cohort study on multiple sclerosis patients, screened with Patient Assessment of Constipation Quality of Life questionnaire before undergoing constipation and faecal incontinence scoring, abdomen X-ray for intestinal transit time, compilation of food and evacuation diaries and faecal sample collection for gut microbiota analysis before and after 4 weeks of trans-anal irrigation. Results and Conclusions: Eighty patients were screened of which nearly half had intestinal symptoms. The included population (n = 37) was predominantly composed of women with significantly longer disease duration, higher mean age and disability than the excluded one (p < 0.05). Twelve patients completed the trans-anal irrigation phase, which led to significant improvement of bowel dysfunction symptom-related quality of life, increase in gut microbiota diversity and reduction of the proportions of pro-inflammatory taxa (p < 0.05). Trans-anal irrigation was safe, satisfactory and could help counteract multiple sclerosis-related dysbiosis.
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INTRODUCTION: In low tuberculosis (TB) incidence countries, foreign-born individuals represent a population at risk. Knowledge, Attitude and Practice (KAP) surveys use standardized and structured questionnaires to collect information by a specific population in relation to a particular topic. As primary objective, we developed and validated a questionnaire exploring TB knowledge among foreign-born individuals from high TB incidence countries living in Ferrara's province, a low TB incidence province of northern Italy. As secondary objective, we investigated respondents' demographic and social determinants of health data. METHODOLOGY: Questionnaire items were developed based on World Health Organization (WHO) "A guide to develop KAP surveys" questionnaire sample and literature review. Questionnaire underwent Delphi technique evaluation, back and forward translation, health literacy review, and two pilot tests. Internal consitency and validity were computed through Cronbach's alpha, content validity index, and principal component analysis (PCA). Descriptive statistics were used to summarize demographic and social determinants of health data. RESULTS: We initially proposed a 38-item questionnaire. After Delphi technique, performed with seven experts, a 17-items questionnaire was obtained. Cronbach's alpha coefficient, used to assess internal consistency, was 0.65. Content validity index was > 0.80. One factor was extracted by PCA, with a cumulative contribution of 50%. The population investigated was similar to the immigrant population settled in Ferrara's province, according to age, gender and TB risk factors. CONCLUSIONS: The questionnaire we developed and validated can contribute to measure foreign-born individuals' TB knowledge.
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Conocimientos, Actitudes y Práctica en Salud , Tuberculosis , Humanos , Internacionalidad , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Tuberculosis/epidemiologíaRESUMEN
Background: Hospital readmissions have become a more examined indicator of surgical care delivery and quality. There is scarcity of data in the literature on the rate, risk factors, and most common reasons of readmission following major hiatal hernia surgery. The primary endpoint was 90-day readmission after surgery for large hiatal hernia. Secondary endpoint was to examine which characteristics related with a higher risk of readmission. Methods: A retrospective review of two distinct institutional databases was performed for patients who had surgery for a large hiatal hernia between January 2012 and December 2019. Demographic, perioperative, and outpatient data were collected from the medical record. Results: A total of 71 patients met the inclusion criteria, most of them suffering from a type III hernia (66.2%). Mean operative time was 146 (±56.5) minutes and median length of stay (LOS) was 6 days (interquartile range = 3). The overall morbidity was 21.1% and the in-hospital mortality was 1.4%. The 30- and 90-day readmission rates were 7% and 8.5%, respectively. The mean time to readmission was 14.3 (±15.6) days. The reasons for 90-day hospital readmission were dysphagia (50%), pneumonia (16.7%), congestive heart failure (16.7%), and bowel obstruction (16.7%). Grade of esophagitis ≥2, presence of Barrett's esophagus, and LOS longer than 8 days were significant risk factors for unplanned readmission within 90 days. Conclusion: We observed that about 6 out of 71 patients who had surgery readmitted within 90 days (8.5%). Readmissions were most often linked to esophagitis ≥2, presence of Barrett's esophagus, and LOS longer than 8 days. These findings point to the necessity for focused treatments before, during, and after hospitalization to decrease morbidity and extra costs in this high-risk population.
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Esófago de Barrett , Esofagitis , Hernia Hiatal , Hernia Hiatal/complicaciones , Humanos , Readmisión del Paciente , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Cut-out is one of the most common mechanical failures in the internal fixation of trochanteric hip fractures. The tip-apex distance (TAD), and the calcar-referenced tip apex distance (CalTAD) are the radiographic parameters that most predict the risk of cut-out. The optimal CalTAD value has not yet been defined, but the optimal TAD value is reported as 25 mm or less. However, this cut-off is highly specific but poorly sensitive. The aim of this study was to determine highly specific and sensitive TAD and CalTAD values and shed light on the role of other clinical variables. A total of 604 patients were included in this retrospective cross-sectional study. For each patient the following data were recorded: number of cut-out, AO/OTA classification, quality of the reduction, type of nail, cervicodiaphyseal angle, type of distal locking, post-operative weight-bearing, TAD and CalTAD values, and the position of the screw head in the femoral head according to the Cleveland system. The incidence of cut-out across the sample was 3.1%. The median TAD in the cut-out group was 38.72, while in the no cut-out group it was 22.16. The median CalTAD in the cut-out group was 39.34, while in the no cut-out group it was 22.19. The cut-off values for TAD and CalTAD with highest value of sensitivity and specificity for the risk of cut-out were 34.8 and 35.2, respectively. The incidence of cut-out can be reduced by performing careful minimal reduction and ensuring stable fixation by avoiding TAD > 34.8 mm and CalTAD > 35.2 mm.
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Clavos Ortopédicos , Tornillos Óseos , Fémur/cirugía , Fijación Intramedular de Fracturas/efectos adversos , Fijación Intramedular de Fracturas/instrumentación , Fracturas de Cadera/cirugía , Falla de Prótesis , Anciano , Anciano de 80 o más Años , Puntos Anatómicos de Referencia , Estudios Transversales , Bases de Datos Factuales , Femenino , Fémur/diagnóstico por imagen , Fémur/lesiones , Fracturas de Cadera/diagnóstico por imagen , Humanos , Masculino , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Insuficiencia del TratamientoRESUMEN
INTRODUCTION: This study aimed at assessing the long-term oncological outcomes of intracorporeal ileocolic anastomosis (ICA) for laparoscopic right hemicolectomy for colon cancer compared with extracorporeal anastomosis (ECA). MATERIAL AND METHODS: We performed a retrospective analysis of 149 consecutive patients who underwent laparoscopic right hemicolectomy for colon cancer between January 2006 and December 2012. RESULTS: Eighty and 69 patients underwent intracorporeal and ECA, respectively. The two groups were demographically comparable. ICA exhibited a significantly shorter operative time (p < .0001), while local relapse and length of hospital stay did not significantly differ among the groups (p = .724 and .310, respectively). There was no significant difference in median number of retrieved lymph node. The overall survival and the disease-free survival at five years did not significantly differ among the groups. CONCLUSIONS: Intracorporeal ICA can reduce operative time and is associated with similar postoperative and long-term oncological outcomes compared to the ECA technique.
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Laparoscopía , Anastomosis Quirúrgica , Colectomía , Humanos , Recurrencia Local de Neoplasia , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: The primary aim of this study was to evaluate the 30-day survival of nonagenarian patients who underwent non-traumatic emergency abdominal surgery. Other aims were: 90-day and 12-month survival rates, the postoperative complications rate, the impact of the emergency operation on postoperative functional status, the accuracy of the P-POSSUM in predicting 30-day postoperative mortality and changes in care services after surgery. METHODS: This was a retrospective cohort study of nonagenarian patients who underwent non-traumatic emergency abdominal surgery between January 2010 and June 2017. Patients were divided in two groups according to the 30-day survival status to compare the distribution of patients' characteristics and postoperative outcomes. Overall survival was estimated using the Kaplan-Meier method. To assess the accuracy of P-POSSUM to predict 30-day mortality, a receiver operating characteristic curve and the Hosmer-Lemeshow goodness of fit test were used. RESULTS: 85 nonagenarian patients were enrolled in this study; of these, 27 (31.8%) died within 30 days. The Kaplan-Meier curve showed a rapid decline in survival over the first 30 postoperative days, followed by a more gradual reduction during the rest of the first year. The majority of patients (92.6%) who died within 30 days experienced a medical complication, with a preponderance of respiratory failure (48.2%) and multiple organ failure (33.3%). In the surviving patients, the postoperative functional status had worsened, and 64.2% of patients did not return to their original housing situation or were institutionalized. The accuracy of P-POSSUM in predicting 30-day mortality in nonagenarian patients was poor. CONCLUSIONS: This study may help doctors convey the postoperative risks of morbidity and mortality, and also to adequately inform relatives about the possible adverse discharge destination of surviving nonagenarian patients with a consequent increase in care needs.
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Abdomen , Nonagenarios , Anciano de 80 o más Años , Humanos , Complicaciones Posoperatorias/epidemiología , Periodo Posoperatorio , Curva ROC , Estudios Retrospectivos , Medición de Riesgo/métodosRESUMEN
Dimethyl fumarate (DMF) is a fumaric acid esters derivate approved for plaque psoriasis as first-line systemic therapy. It has been available in Italy since 2017 and an increasing number of patients are treated with this drug. To evaluate DMF effectiveness, side effects and drug survival in a dermatological real-life setting. We performed a retrospective multi-center study in five dermatologic clinics in Emilia-Romagna, Northern Italy, which included all consecutive patients affected by moderate-severe psoriasis treated with DMF. We assessed effectiveness (in terms of PASI50 and PASI75 in an intention to treat observation) and safety (occurrence of side effects) of DMF and their association with demographic and disease characteristics, mean daily dose taken and treatment discontinuation. We included 103 patients, 78 (75.72%) had at least one comorbidity including 19 (18.44%) with a history of cancer; the mean treatment duration was 23.61 ± 17.99 weeks (min 4, max 130) and the mean daily dose was 262.13 ± 190.94 mg. Twenty-four patients (23.30%) reached PASI75 at week 12, while a further 18 patients (17.47%) reached it at week 26. Side effects occurred in 63 patients (61.16%), the most frequent were diarrhea, epigastric discomfort, nausea, and flushing. Sixteen patients (15.53%) showed an alteration of laboratory tests. In some cases side effects were transitory, while in 53 patients (51.45%) they led to cessation of therapy. The median daily dose showed a direct association with PASI50 achievement and an indirect association with treatment discontinuation. Our study shows the peculiarities of DMF in a real-world setting: effectiveness is often reached after 12 weeks of treatment and side effects could limit the continuation of the therapy but, at the same time, DMF has no major contraindications and, due to the wide range of dosage, it can allow both to manage side effects and to personalize the prescription for each patient.
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Fármacos Dermatológicos , Psoriasis , Fármacos Dermatológicos/efectos adversos , Dimetilfumarato/efectos adversos , Fumaratos/efectos adversos , Humanos , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVES: This study aimed to identify the guiding ethical principles that should be considered for critical resource allocation during pandemic emergency situations, and especially for the COVID-19 outbreak. The secondary objective was to define the priority to be assigned to each principle. SETTING: The study was conducted from March to June 2020 within the context of an ethical committee (EC) in Northern Italy. PARTICIPANTS: Eleven EC members and five additional external healthcare and bioethical professionals, forming a multidisciplinary panel, took part in the study. PRIMARY AND SECONDARY OUTCOME MEASURES: The compilation of a list of ethical principles (maximum of 10 items) and their priority ranking and application within an emergency pandemic context was established as the expected outcome of this work. RESULTS: A consensus on 10 guiding ethical principles was reached by the multidisciplinary panel. Transparency ranked first on the priority list as the most frequently voted principle, followed by the number of lives saved, life-years saved, respect for individuals' autonomy and equity. Other principles including life cycle, 'sickest first', reciprocity, instrumental value and lottery were also considered appropriate as potential tiebreakers. These principles were discussed and made consistent with the current Italian pandemic context by producing an explanatory document. CONCLUSIONS: The identified principles could be used in preparedness plans to guide resource allocation during pandemic events. By combining their rank and relevance in relation to disease, health system organisations, social and economic settings, and critical resources at risk of scarcity, these principles could help to maximise the benefit of resource use for the community, thus reducing inequalities for individuals.
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COVID-19 , Pandemias , Humanos , Italia/epidemiología , SARS-CoV-2 , TriajeRESUMEN
BACKGROUND: Mesenchymal stem cells derived from adipose tissue have been successfully used to promote sphincter-saving anal fistula healing. OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of the use of autologous centrifuged adipose tissue in the healing process of cryptoglandular complex anal fistulas. DESIGN: This is a randomized controlled trial. SETTINGS: This study was conducted at a single center. PATIENTS: Patients with complex perianal fistulas not associated with Crohn's disease were included. Rectovaginal fistulas were not included. INTERVENTIONS: Patients were randomly allocated to receive treatment with centrifuged adipose tissue injection (experimental group) and without injection (control group) in combination with fistula surgery. MAIN OUTCOME MEASURES: The primary outcome was defined as the proportion of patients with complete fistula closure at 4 weeks (short-term outcome) and 6 months after surgery (long-term outcome). Healing was defined as when the external opening was closed with no perianal discharge on clinical assessment. The secondary outcome was safety that was evaluated by the analysis of adverse events up to 3 months after surgery. Pelvic MRI was performed at 3 months to assure safety and the accuracy of the clinical determination of healing. Postoperative pain, return to work/daily activities, persistent closure at 6 months, fecal incontinence, and patient satisfaction were evaluated. RESULTS: Fifty-eight patients who received centrifuged adipose tissue injection and 58 patients who did not receive centrifuged adipose tissue injection were included in the safety and efficacy analysis. After 4 weeks, the healing rate was 63.8% in the experimental group compared with 15.5% in the control group (p < 0.001). No major adverse events were recorded. Postoperative anal pain was significantly lower in the injection group. Time taken to return to work/daily activities was significantly shorter in the experimental group (3 days) than in the control group (17 days). At 6 months, persistent closure was similar in the 2 groups (86.2% vs 81%). Fecal Incontinence Score at 6 months after surgery was identical to the preoperative score. Patient satisfaction was high in both groups. LIMITATIONS: The absence of blinding, the lack of correlation between stem cell content, and the clinical outcome were limitations of the study. CONCLUSIONS: Autologous centrifuged adipose tissue injection may represent a safe, efficacious, and inexpensive option for the treatment of complex fistula-in-ano. See Video Abstract at http://links.lww.com/DCR/B607. CLINICAL TRIALS REGISTRATION: URL: https://www.clinicaltrials.gov. Identifier: NCT04326907. EFICACIA Y SEGURIDAD DEL TRATAMIENTO DE LA FSTULA ANAL COMPLEJA IDIOPTICA UTILIZANDO TEJIDO ADIPOSO CENTRIFUGADO AUTLOGO QUE CONTIENE CLULAS PROGENITORAS UN ENSAYO CONTROLADO ALEATORIO: ANTECEDENTES:Las células madre mesenquimales derivadas del tejido adiposo se han utilizado con éxito para promover la curación de la fístula anal con preservación de esfínter.OBJETIVO:El objetivo de este estudio fue evaluar la eficacia y seguridad del uso de tejido adiposo autólogo centrifugado en el proceso de cicatrización de fístulas anales complejas de origen criptoglandular.DISEÑO:Ensayo controlado aleatorio.ENTORNO CLÍNICO:Estudio unicéntrico.PACIENTES:Se incluyeron pacientes con fístulas perianales complejas no asociadas a Enfermedad de Crohn. No se incluyeron las fístulas rectovaginales.INTERVENCIONES:Los pacientes fueron asignados aleatoriamente para recibir tratamiento con inyección de tejido adiposo centrifugado (grupo experimental) y sin inyección (grupo de control) en combinación con cirugía de fístula.PRINCIPALES MEDIDAS DE VALORACIÓN:El resultado primario se definió como la proporción de pacientes con cierre completo de la fístula a las 4 semanas (resultado a corto plazo) y 6 meses después de la cirugía (resultado a largo plazo). La curación se definió cuando orificio externo se cerró sin secreción perianal en la valoración clínica. El resultado secundario fue la seguridad que se evaluó mediante el análisis de los eventos adversos (EA) hasta 3 meses después de la cirugía. La resonancia magnética pélvica se realizó a los 3 meses para garantizar la seguridad y la precisión clínica de la curación. Se evaluó el dolor postoperatorio, el regreso al trabajo / actividades diarias, el cierre persistente a los 6 meses, la incontinencia fecal y la satisfacción del paciente.RESULTADOS:Cincuenta y ocho pacientes que recibieron inyección de tejido adiposo centrifugado y 58 pacientes que no recibieron inyección de tejido adiposo centrifugado se incluyeron en el análisis de seguridad y eficacia. Después de 4 semanas, la tasa de curación fue del 63,8% en el grupo experimental en comparación con el 15,5% en el grupo de control (p <0,001). No se registraron eventos adversos importantes. El dolor anal posoperatorio fue significativamente menor en el grupo de inyección. El tiempo necesario para volver al trabajo / actividades diarias fue significativamente menor en el grupo experimental (3 días) con respecto al grupo de control (17 días). A los 6 meses, el cierre persistente fue similar en los dos grupos (86,2% vs 81%). La puntuación de incontinencia fecal a los 6 meses después de la cirugía fue idéntica a la puntuación preoperatoria. La satisfacción del paciente fue muy alta en ambos grupos.LIMITACIONES:Ausencia de cegamiento, falta de correlación entre el contenido de células madre y el resultado clínico.CONCLUSIONES:La inyección de tejido adiposo centrifugado autólogo puede representar una opción segura, eficaz y económica para el tratamiento de la fístula anal compleja.Registro de ensayos clínicos: www.clinicaltrials.gov, identificador NCT04326907; No patrocinado.Consulte Video Resumen en http://links.lww.com/DCR/B607.
Asunto(s)
Tejido Adiposo/citología , Trasplante de Células Madre Mesenquimatosas/efectos adversos , Fístula Rectal/terapia , Cicatrización de Heridas/fisiología , Estudios de Casos y Controles , Incontinencia Fecal/epidemiología , Femenino , Humanos , Inyecciones Subcutáneas/métodos , Italia/epidemiología , Imagen por Resonancia Magnética/métodos , Masculino , Trasplante de Células Madre Mesenquimatosas/métodos , Células Madre Mesenquimatosas , Persona de Mediana Edad , Dolor Postoperatorio/epidemiología , Satisfacción del Paciente/estadística & datos numéricos , Pelvis/diagnóstico por imagen , Fístula Rectal/patología , Reinserción al Trabajo/estadística & datos numéricos , Seguridad , Resultado del TratamientoRESUMEN
The Coronavirus disease 2019 (COVID-19) pandemic continues to affect millions worldwide and has posed unique challenges to healthcare professionals. Caring for patients during a pandemic may have negative impacts on their mental health. We describe the first part of a study using a mixed-method sequential explanatory design (QUANTâQUAL). This quantitative part examines the experiences of healthcare professionals during the pandemic in a University Hospital in Italy. We performed a cross-sectional hospital-based survey involving all healthcare professionals between 19 May 2020 and 3 June 2020. Perceived Stress Scale, Patient Health Questionnaire, and General Anxiety Disorder scores were calculated, in order to assess how the pandemic emergency changed the occupational and social habits of the healthcare professionals. The mean age of the 275 respondents was 47 years and females accounted for 80.2%. A total of 29.8% had a Perceived Stress Scale (PSS) score ≥25, 22.9% scored ≥15 on the Patient Health Questionnaire (PHQ-9) scale, and 17.1% scored ≥15 on the General Anxiety Disorder (GAD) scale. Stress symptoms were mostly manifested for interviewees over 55, females, those who live far from their family, those who have only one child, and those who had a qualification lower than high school or who had a medical specialization. Our findings show a relevant level of psychological distress, anxiety, and depression in up to 30% of the sample, highlighting a significant psychological burden in all professionals.