Ambulatory surgery for perianal Crohn’s disease. Study of feasibility

Background. One-third of Crohn’s disease (CD) patients present perianal fistula. The gold standard in the diagnosis and treatment of symptomatic perianal disease (PAD) in CD is the exploration of the anal canal and distal rectum under anesthesia (EUA). This procedure is mainly conducted as a day case surgery. Unfortunately, it is not always possible to proceed within the ideal timing and any delay may well represent a relevant clinical issue. The aim of this study was to evaluate the feasibility of outpatient treatment of symptomatic perianal fistulas in CD patients. Methods. All CD patients under regular follow-up at our inflammatory bowel disease referral center, presenting with symptomatic perianal fistulas, were offered surgical consultation. The data of patients were prospectively collected for three years (February 2014 to February 2017) for the purpose of the study. All clinical information, including previous EUA and/or records from MRI and endoscopic ultrasound, was included. Outpatient anal canal and distal rectum exploration and treatment (OE) were undertaken during the specialist surgical consultation. Fistulas were classified according to Parks’s classification; the type of outpatient treatment and compliance of patients were recorded. Pain was assessed by VAS at the time of the procedure and during the first control. Patients were followed up in the surgical clinic in relation to the study. Results. Ninety-two CD patients with symptomatic perianal fistulas had surgical consultation during the study period. OE was offered to all but 18 patients who fulfilled the exclusion criteria or had an extremely severe disease; six patients refused the OE (8.11%). Of the 68 patients undergoing OE, eleven (16.18%) had previous surgery for perianal disease. The OE was accomplished in sixty-one patients (89.71%), while in 7 patients, it was abandoned for scarce compliance. Nine patients (14.75%) underwent drainage of perianal abscess; in 3 of them, it was possible to probe the fistula tract, find the internal orifice, and pass a loose seton. Overall, setonage was performed in 50 patients (81.97%). Rectovaginal setons were placed in 3 patients and more than one seton (up to 3) in 6 cases. Fistulotomy was performed in 4 simple subcutaneous fistulous tracts. Concordance with the preoperative findings was found in 54 out of 61 patients. EUA was scheduled at the time of OE for the 7 patients who did not complete the procedure. All sixty-one patients who had the OE were followed up for a minimum of 12 months. Conclusions. This preliminary study indicates that OE in CD patients with symptomatic perianal fistulas is safe and feasible in a high-volume referral center. It might provide several benefits, including patients’ logistics, reduce or remove patients’ symptoms and discomfort, allow for a timely start of medical therapy, and avoid further complications

Anatomy and kinematic evolution of an ancient passive margin involved into an orogenic wedge (Western Southern Alps, Varese area, Italy and Switzerland)

We make use of own geological mapping, interpretations of seismic reflection profiles and deep geophysical data to build a lithospheric-scale cross-section across the European Western Southern Alps (Varese area) and to model a progressive restoration from the end of Mesozoic rifting to present-day. Early phases of Alpine orogeny were characterized by Europe-directed thrusting, whereas post-Oligocene shortening led to basement-involving crustal accretion accompanied by backfolding, and consistent with the kinematics of the adjoining Ivrea Zone. Wedging was favored by a significant component of reactivation of the inherited Adriatic rifted margin. Our results also suggest that, during the collisional and post-collisional tectonics, lithosphere dynamics drove diachronically the onset of tectonic phases (i.e., wedging and slab retreat), from east to west, across the Western Southern Alps

Insights about the interaction of methotrexate loaded hydrophilic gold nanoparticles: spectroscopic, morphological and structural characterizations

Gold nanoparticles (AuNPs) are promising carriers in the field of nanomedicine and represent a very intriguing approach in drug delivery applications, due to their small size and enhanced properties. This work aims to highlight the interaction between functionalized AuNPs and the immune-system suppressant drug Methotrexate (MTX) at molecular level. Small and monodisperse (<2RH>5 ± 1 nm) gold nanoparticles were prepared by a simple chemical route using hydrophilic thiol 3-mercapto-1-propanesulfonate (3MPS) as a functionalizing/ capping agent and act as a platform for post-synthesis conjugation of MTX via non-covalent interaction. The AuNPs-3MPS@MTX bioconjugate and the AuNPs alone were characterized to investigate their optical, chemical, and morphological properties. Moreover, NMR, AFM, SAXS, HR-TEM and SR-XPS data confirmed the spherical shape of AuNPs and allowed to determine the mechanisms behind such drug-nanoparticle physicochemical interactions. These analyses define the overall structure of drug-loaded AuNPs-3MPS and drug location on the colloidal nanoparticles surface. Based on the experimental data, it is notable to assert that MTX was successfully loaded on the negatively charged nanoparticles surface via electrostatic interactions. The physicochemical behavior leads to the formation of large clusters with close packed arrangement of AuNPs-3MPS@MTX. This selfassembling property is of importance for delivery purpose affecting the drug-loaded nanoparticle size, functionality, and morphology. Knowledge of how these systems behave will aid in increasing drug efficacy and in understanding the pharmacodynamics and pharmacokinetic properties, opening to new physicochemical insight for therapy and drug delivery systems

Safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia (NeoNATI).

Abstract Background Despite progresses in neonatal care, the mortality and the incidence of neuro-motor disability after perinatal asphyxia have failed to show substantial improvements. In countries with a high level of perinatal care, the incidence of asphyxia responsible for moderate or severe encephalopathy is still 2–3 per 1000 term newborns. Recent trials have demonstrated that moderate hypothermia, started within 6 hours after birth and protracted for 72 hours, can significantly improve survival and reduce neurologic impairment in neonates with hypoxic-ischemic encephalopathy. It is not currently known whether neuroprotective drugs can further improve the beneficial effects of hypothermia. Topiramate has been proven to reduce brain injury in animal models of neonatal hypoxic ischemic encephalopathy. However, the association of mild hypothermia and topiramate treatment has never been studied in human newborns. The objective of this research project is to evaluate, through a multicenter randomized controlled trial, whether the efficacy of moderate hypothermia can be increased by concomitant topiramate treatment. Methods/Design Term newborns (gestational age ≥ 36 weeks and birth weight ≥ 1800 g) with precocious metabolic, clinical and electroencephalographic (EEG) signs of hypoxic-ischemic encephalopathy will be randomized, according to their EEG pattern, to receive topiramate added to standard treatment with moderate hypothermia or standard treatment alone. Topiramate will be administered at 10 mg/kg once a day for the first 3 days of life. Topiramate concentrations will be measured on serial dried blood spots. 64 participants will be recruited in the study. To evaluate the safety of topiramate administration, cardiac and respiratory parameters will be continuously monitored. Blood samplings will be performed to check renal, liver and metabolic balance. To evaluate the efficacy of topiramate, the neurologic outcome of enrolled newborns will be evaluated by serial neurologic and neuroradiologic examinations. Visual function will be evaluated by means of behavioural standardized tests. Discussion This pilot study will explore the possible therapeutic role of topiramate in combination with moderate hypothermia. Any favourable results of this research might open new perspectives about the reduction of cerebral damage in asphyxiated newborns. Trial registration Current Controlled Trials ISRCTN62175998; ClinicalTrials.gov Identifier NCT01241019; EudraCT Number 2010-018627-25</p

Malnutrition and Disability: A Retrospective Study on 2258 Adult Patients Undergoing Elective Spine Surgery.

Background and Objectives: Malnutrition's prevalence and its relationship with functional ability in patients with end-stage spine pathologies, i.e., any disease of the vertebral bodies, intervertebral discs, and associated joints requiring surgical intervention, are yet to be explored. This retrospective study aimed to investigate the association between malnutrition, disability, and physical health in patients undergoing elective spine surgery in our Italian hospital. Materials and Methods: Data between 2016 and 2019, recorded at pre-admission visits, were extracted from our institutional spine registry (ClinicalTrials.gov number: NCT03644407), excluding minor patients or those undergoing emergency or oncological surgery. The measures were the Oswestry disability index (ODI) and the physical health (PH) summary of the 36-item Short-Form Health Survey. Clinical data were linked to nine laboratory parameters from pre-operative routine blood tests, and equations to ascertain the risk of malnutrition and its diagnosis were attributed. Results: The study sample included 2258 spine patients (58.15% females) who underwent surgery in our Italian hospital. The ODI and PH significantly varied across body weight difference (BWd) strata in younger adults (adjusted-p = 0.046, η2 = 0.04; adjusted-p = 0.036, η2 = 0.06) and adults (adjusted-p = 0.001, η2 = 0.02; adjusted-p = 0.004, η2 = 0.02). Protein malnutrition with acute/chronic inflammation (PMAC) in both adults (adjusted-p < 0.001, η2 = 0.04; adjusted-p < 0.001, η2 = 0.04) and older adults (adjusted-p = 0.010, η2 = 0.04; adjusted-p = 0.009, η2 = 0.05) had also a discernible impact in determining the ODI and PH. In older adults, the ODI was associated with iron deficit malnutrition (IDM) (adjusted-p = 0.005, η2 = 0.06) and both the ODI and PH were associated with vitamin B deficit (VBD) (adjusted-p = 0.037, η2 = 0.01; adjusted-p = 0.049, η2 = 0.01). Trend monotonicity was diagnosis- and sex-specific, with meaningful ordered patterns being observed mostly in young males and older females. Conclusions: Functional ability showed an association with malnutrition in younger adults and adults when using BWd, in adults and older adults when using PMAC, and in older adults when using IDM and VBD. The authors advocate for the inclusion of nutritional management in the pre-operative evaluation to potentially enhance recovery after spine surgery

Epidemiological analysis of intra-abdominal infections in Italy from the Italian register of complicated intra-abdominal infections—the IRIS study: a prospective observational nationwide study

BackgroundIntra-abdominal infections (IAIs) are common and severe surgical emergencies associated with high morbidity and mortality. In recent years, there has been a worldwide increase in antimicrobial resistance associated with intra-abdominal infections, responsible for a significant increase in mortality rates. To improve the quality of treatment, it is crucial to understand the underlying local epidemiology, clinical implications, and proper management of antimicrobial resistance, for both community- and hospital-acquired infections. The IRIS study (Italian Register of Complicated Intra-abdominal InfectionS) aims to investigate the epidemiology and initial management of complicated IAIs (cIAIs) in Italy.Material and methodThis is a prospective, observational, nationwide (Italy), multicentre study. approved by the coordinating centre ethic committee (Local Research Ethics Committee of Pisa (Prot n 56478//2019). All consecutively hospitalized patients (older than 16 years of age) with diagnosis of cIAIs undergoing surgery, interventional drainage or conservative treatment have been included.Results4530 patients included from 23 different Italian hospitals. Community Acquired infection represented the 70.9% of all the cases. Among appendicitis, we found that 98.2% of the cases were community acquired (CA) and 1.8% Healthcare-associated (HA) infections. We observed that CA represented the 94.2% and HA 5.8% of Gastro Duodenal perforation cases. The majority of HA infections were represented by colonic perforation and diverticulitis (28.3%) followed by small bowel occlusion (19%) and intestinal ischemia (18%). 27.8% of patients presented in septic shock. Microbiological Samples were collected from 3208 (70.8%) patients. Among 3041 intrabdominal sample 48.8% resulted positive. The major pathogens involved in intra-abdominal infections were found to be E.coli (45.6%). During hospital stay, empiric antimicrobial therapy was administered in 78.4% of patients. Amoxicillin/clavulanate was the most common antibiotic used (in 30.1% appendicitis, 30% bowel occlusion, 30.5% of cholecystitis, 51% complicated abdominal wall hernia, 55% small bowel perforation) followed by piperacillin/tazobactam (13.3% colonic perforation and diverticulitis, 22.6% cholecystitis, 24.2% intestinal ischemia, 28.6% pancreatitis). Empiric antifungal therapy was administered in 2.6% of patients with no sign of sepsis, 3.1% of patients with clinical sign of sepsis and 4.1% of patients with septic shock. Azoles was administered in 49.2% of patients that received empiric antifungal therapy. The overall mortality rate was 5.13% (235/4350). 16.5% of patients required ICU (748/4350). In accordance with mortality, it is important to highlight that 35.7% of small bowel perforation, 27.6% of colonic perforation and diverticulitis, 25.6% of intestinal ischemia and 24.6% of gastroduodenal complications required ICU.ConclusionAntibiotic stewardship programs and correct antimicrobial and antimycotic prescription campaigns are necessary to ulteriorly improve the adequacy of drug usage and reduce the resistances burden. This will help in improving the care and the cure of the next generations

Laparoscopic right hemicolectomy: a SICE (Società Italiana di Chirurgia Endoscopica e Nuove tecnologie) network prospective study on the approach to right colon lymphadenectomy in Italy: is there a standard?—CoDIG 2 (ColonDx Italian Group)

Background: Colon cancer is a disease with a worldwide spread. Surgery is the best option for the treatment of advanced colon cancer, but some aspects are still debated, such as the extent of lymphadenectomy. In Japanese guidelines, the gold standard was D3 dissection to remove the central lymph nodes (203, 213, and 223), but in 2009, Hoenberger et al. introduced the concept of complete mesocolic excision, in which surgical dissection follows the embryological planes to remove the mesentery entirely to prevent leakage of cancer cells and collect more lymph nodes. Our study describes how lymphadenectomy is currently performed in major Italian centers with an unclear indication on the type of lymphadenectomy that should be performed during right hemicolectomy (RH). Methods: CoDIG 2 is an observational multicenter national study that involves 76 Italian general surgery wards highly specialized in colorectal surgery. Each center was asked not to modify their usual surgical and clinical practices. The aim of the study was to assess the preference of Italian surgeons on the type of lymphadenectomy to perform during RH and the rise of any new trends or modifications in habits compared to the findings of the CoDIG 1 study conducted 4&nbsp;years ago. Results: A total of 788 patients were enrolled. The most commonly used surgical technique was laparoscopic (82.1%) with intracorporeal (73.4%), side-to-side (98.7%), or isoperistaltic (96.0%) anastomosis. The lymph nodes at the origin of the vessels were harvested in an inferior number of cases (203, 213, and 223: 42.4%, 31.1%, and 20.3%, respectively). A comparison between CoDIG 1 and CoDIG 2 showed a stable trend in surgical techniques and complications, with an increase in the robotic approach (7.7% vs. 12.3%). Conclusions: This analysis shows how lymphadenectomy is performed in Italy to achieve oncological outcomes in RH, although the technique to achieve a higher lymph node count has not yet been standardized. Trial registration (ClinicalTrials.gov) ID: NCT05943951

Acute diverticulitis in immunocompromised patients: evidence from an international multicenter observational registry (Web-based International Register of Emergency Surgery and Trauma, Wires-T)

Background: Immunocompromised patients with acute diverticulitis are at increased risk of morbidity and mortality. The aim of this study was to compare clinical presentations, types of treatment, and outcomes between immunocompromised and immunocompetent patients with acute diverticulitis. Methods: We compared the data of patients with acute diverticulitis extracted from the Web-based International Registry of Emergency Surgery and Trauma (WIRES-T) from January 2018 to December 2021. First, two groups were identified: medical therapy (A) and surgical therapy (B). Each group was divided into three subgroups: nonimmunocompromised (grade 0), mildly to moderately (grade 1), and severely immunocompromised (grade 2). Results: Data from 482 patients were analyzed—229 patients (47.5%) [M:F = 1:1; median age: 60 (24–95) years] in group A and 253 patients (52.5%) [M:F = 1:1; median age: 71 (26–94) years] in group B. There was a significant difference between the two groups in grade distribution: 69.9% versus 38.3% for grade 0, 26.6% versus 51% for grade 1, and 3.5% versus 10.7% for grade 2 (p &lt; 0.00001). In group A, severe sepsis (p = 0.027) was more common in higher grades of immunodeficiency. Patients with grade 2 needed longer hospitalization (p = 0.005). In group B, a similar condition was found in terms of severe sepsis (p = 0.002), quick Sequential Organ Failure Assessment score &gt; 2 (p = 0.0002), and Mannheim Peritonitis Index (p = 0.010). A Hartmann’s procedure is mainly performed in grades 1–2 (p &lt; 0.0001). Major complications increased significantly after a Hartmann’s procedure (p = 0.047). Mortality was higher in the immunocompromised patients (p = 0.002). Conclusions: Immunocompromised patients with acute diverticulitis present with a more severe clinical picture. When surgery is required, immunocompromised patients mainly undergo a Hartmann’s procedure. Postoperative morbidity and mortality are, however, higher in immunocompromised patients, who also require a longer hospital stay

Deep learning neural network prediction of postoperative complications in patients undergoing laparoscopic right hemicolectomy with or without CME and CVL for colon cancer: insights from SICE (Società Italiana di Chirurgia Endoscopica) CoDIG data

BackgroundPostoperative complications in colorectal surgery can significantly impact patient outcomes and healthcare costs. Accurate prediction of these complications enables targeted perioperative management, improving patient safety and optimizing resource allocation. This study evaluates the application of machine learning (ML) models, particularly deep learning neural networks (DLNN), in predicting postoperative complications following laparoscopic right hemicolectomy for colon cancer.MethodsData were drawn from the CoDIG (ColonDx Italian Group) multicenter database, which includes information on patients undergoing laparoscopic right hemicolectomy with complete mesocolic excision (CME) and central vascular ligation (CVL). The dataset included demographic, clinical, and surgical factors as predictors. Models such as decision trees (DT), random forest (RF), and DLNN were trained, with DLNN evaluated using cross-validation metrics. To address class imbalance, the synthetic minority over-sampling technique (SMOTE) was employed. The primary outcome was the prediction of postoperative complications within 1 month of surgery.ResultsThe DLNN model outperformed other models, achieving an accuracy of 0.86, precision of 0.84, recall of 0.90, and an F1 score of 0.87. Relevant predictors identified included intraoperative minimal bleeding, blood transfusion, and adherence to the fast-track recovery protocol. The absence of intraoperative bleeding, intracorporeal anastomosis, and fast-track protocol adherence were associated with a reduced risk of complications.ConclusionThe DLNN model demonstrated superior predictive performance for postoperative complications compared to other ML models. The findings highlight the potential of integrating ML models into clinical practice to identify high-risk patients and enable tailored perioperative care. Future research should focus on external validation and implementation of these models in diverse clinical settings to further optimize surgical outcomes