Botulinum toxin injection for chronic anal fissure: a prospective controlled study with long follow-up.

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.

PAttern of drug use in PEdiatrics: An observational study in Italian hOSpitals (the PAPEOS study).

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.

The Impact of GLP-1 RAs and DPP-4is on Hospitalisation and Mortality in the COVID-19 Era: A Two-Year Observational Study.

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.

Association of the Extent of Resection with Survival in Multiple Primary Lung Cancer: A Systematic Review.

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.

Factors Associated with Early Discharge after Thoracoscopic Lobectomy: Results from the Italian VATS Group Registry.

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.

Professional practice, competence, and education related to COVID-19: A mixed-methods light study of physiotherapists' experiences.

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.

Glucose Metabolism Modification Induced by Radioligand Therapy with [177Lu]Lu/[90Y]Y-DOTATOC in Advanced Neuroendocrine Neoplasms: A Prospective Pilot Study within FENET-2016 Trial.

[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.

Trans-anal irrigation in patients with multiple sclerosis: Efficacy in treating disease-related bowel dysfunctions and impact on the gut microbiota: A monocentric prospective study.

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.

Analysis of Rates, Causes, and Risk Factors for 90-Day Readmission After Surgery for Large Hiatal Hernia: A Two-Center Study.

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.

Development and validation of a questionnaire on tuberculosis among foreign-born individuals in a province of northern Italy.

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.

New tip-apex distance and calcar-referenced tip-apex distance cut-offs may be the best predictors for cut-out risk after intramedullary fixation of proximal femur fractures.

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.

Extracorporeal versus intracorporeal anastomosis in laparoscopic right hemicolectomy for cancer.

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.

Non-traumatic emergency abdominal surgery in nonagenarian patients: a retrospective study.

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.

Dimethyl fumarate treatment for psoriasis in a real-life setting: A multicentric retrospective study.

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.

Efficacy and Safety of Treatment of Complex Idiopathic Fistula-in-Ano Using Autologous Centrifuged Adipose Tissue Containing Progenitor Cells: A Randomized Controlled Trial.

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.

Identifying ethical values for guiding triage decisions during the COVID-19 pandemic: an Italian ethical committee perspective using Delphi methodology.

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.

CORONAcrisis-An Observational Study on the Experience of Healthcare Professionals in a University Hospital during a Pandemic Emergency.

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 (QUANT→QUAL). 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.

Does longer duration of corticosteroid treatment improve clearance in vulvar lichen sclerosus? Results from a single centre, comparative, open label study.

A complete clearance of vulvar lichen sclerosus (VLS) is achieved in a minority of patients treated with a standard 12-week duration corticosteroid treatment. The aim of this pragmatic, retrospective, open label, comparative trial was to assess the effectiveness, in terms of complete clearance, of a 24-week treatment with mometasone furoate 0.1% ointment (MMF) and to compare it with a 12-week therapy. We included VLS patients treated with MMF administered for five consecutive days/week for 24 weeks (group A). The following were assessed: (a) clearance in Global Subjective Score (GSS), Global Objective Score (GOS) or both, (b) changes of these parameters and dyspareunia at treatment completion compared to baseline, (c) safety profile. All these assessments were compared with the same outcomes recorded among VLS patients who had previously undergone a 12-week MMF treatment (group B). Twenty-nine patients were included in group A and 32 in group B. The rates of patients who achieved the clearance of GSS, GOS or both parameters did not significantly differ between groups A and B. The groups did not differ in any of the effectiveness outcomes assessed. A 24-week duration corticosteroid treatment does not seem to provide significant therapeutic benefits in comparison with standard 12-week courses, especially considering the occurrence of complete clearance.

Validation of the cross-cultural adapted Italian version of the Oxford Elbow Score.

BACKGROUND: The Oxford Elbow Score (OES) is an English-language questionnaire specifically designed to evaluate surgical elbow outcomes. This scoring system has been translated into other languages. Given the lack of an Italian version of the OES, the present study was designed to establish, culturally adapt, and validate the Italian version. METHODS: The OES questionnaire was culturally adapted to Italian patients in accordance with the literature guidelines with a pilot phase including seven patients with elbow problems and seven healthy subjects. The study includes 110 participants from three hospitals, who underwent elbow surgery for acute (70%) or chronic diseases. At least one month after elbow surgery, at the "index visit", the physician completed the Mayo Elbow Performance Index and patients completed the following questionnaires: the Italian OES, the shortened version of the Disability of Arm, Shoulder and Hand Questionnaire (QuickDASH) and the Short-Form 36 Health Survey. Internal consistency was evaluated using Cronbach's alpha. Reproducibility was assessed using the intraclass correlation coefficient in ten patients who completed the OES again two-three days after the index visit. Construct validity was assessed using Spearman correlation coefficients. Responsiveness was evaluated in 68 patients who answered the questionnaires four months after the index visit, using the Wilcoxon signed-rank test, the effect size and the standardized response mean calculation. RESULTS: Cronbach's alpha was excellent: 0.86 (0.82-0.90) for OES pain, 0.92 (0.90-0.94) for OES function, and 0.90 (0.87-0.93) for OES social/psychological. The intraclass correlation coefficient was 0.94 (0.78-0.98) for OES pain, 0.91 (0.71-0.97) for OES function, 0.95 (0.83-0.98) for OES social-psychological and 0.93 (0.76-0.98) for OES total. The Spearman ρ was >0.7 for OES pain and QuickDASH, for OES function and both QuickDASH and Mayo Elbow Performance Index, and for OES social-psychological and QuickDASH. Regarding responsiveness, the mean of the changes between the two visits ranged from 33.9 for OES pain, to 44 points for OES function and OES social/psychological. The effect size and the standardized response mean were >0.8 for all OES domains. CONCLUSION: This study demonstrates that the Italian version of the OES, translated in accordance with the international standardized guidelines, is reliable, valid, and responsive in patients who have undergone elbow surgery.

Clinical-Diagnostic Relevance of Breast "Incidentaloma" Detected During 18F-Fluoro-2-Deoxy-D-Glucose Positron Emission Tomography/Computed Tomography: Correlation with Radiological Imaging and Histopathology.

AIM: This study aims to study the clinical-diagnostic relevance of incidental breast uptake ("incidentaloma") on 18F-fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography (18F-FDG PET/CT) scan performed for other indications and to correlate it with radiological imaging and histopathology. MATERIALS AND METHODS: We retrospectively evaluated 3675 FDG-PET scans, identifying 43 patients with breast "incidentaloma." Thirty of these findings were further investigated with clinical examination, mammography (MMX), UltraSound (US) and/or magnetic resonance (MR). Cases suspected for malignancy underwent US-guided macro-biopsy (USMB) or MR-guided biopsy. Correlations between FDG-PET, radiology findings, age, and histopathology were evaluated. RESULTS: patients who performed both US and MMX were 19. Ten consequently underwent USMB, one MR-guided biopsy, the remaining 8 were not further investigated. Nine patients had a diagnosis of malignancy. Among 11 patients who performed only US and consequently, USMB 6 had a diagnosis of malignancy. Histopathology of the 22 patients with both morphological and glucometabolic alterations showed different types of benign or malignant neoplasia, with a cumulative 68.2% incidence of malignancy. Seven lesions showed a SUVmax >2.5, while the remaining 15 a SUVmax <2.5. There was no statistically significant correlation between SUVmax and histology, therefore SUVmax parameter should not be used to discriminate between benign and malignant findings. No significant correlation between patient age and tumor characterization was found. CONCLUSIONS: incidental mammary uptake during an FDG-PET scan may represent a clue suggesting to investigate PET findings. In this subset of patients, early diagnosis may lead to a change in clinical management with a favorable impact on prognosis and a significant reduction in healthcare costs.