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"Conoscenti, Giuseppe"
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146 Safety of NER1006 in the Elderly: A Post-Hoc Analysis of a Prospective, Multicenter Cohort
by
Virgilio, Clara Maria
,
Manganaro, Michele
,
Sferrazza, Sandro
in
Colonoscopy
,
Dehydration
,
Electrolytes
2019
INTRODUCTION:The effectiveness of bowel cleansing is a key element for a quality colonoscopy since it affects diagnostic accuracy and adenoma detection rate. A very-low-volume 1L PEG solution (NER1006) has been recently introduced after the publication of three phase 3 randomized controlled trials showing non-inferiority respect to comparators. Despite its proven effectiveness, the safety of NER1006 in the elderly has never been assessed in a real-life setting.METHODS:This study aimed to assess the safety profile of NER1006 in the elderly compared to younger patients in a real-life setting. We performed a post-hoc analysis of data from a cohort of 1289 patients undergoing a colonoscopy after a afternoon-only or a afternoon-morning preparation with a 1, 2 or 4L PEG-based solution consecutively enrolled from September 2018 to February 2019 in 5 Italian centers. The elderly population was defined by an age ≥65 years. Safety was monitored through adverse events reporting.RESULTS:Among 1289 patients, 233 subjects undergoing a bowel preparation with NER1006 were included in the analysis. The mean age was 59.5 ± 15.9 years, 52.4% of patients were male, and 43.5% were older than 65 years old. Mean age was 48.6 ± 11.9 years (range 18–64) in the group of patients aged <65 years, and 73.7 ± 6.3 years (range 65–91) in the group of patients aged ≥65 years, while prevalence of hypertension, diabetes, and obesity was 13.7 vs. 32.7% (P = 0.03), 3.1 vs. 9.9% (P = 0.001) and 12.2 vs. 13.9% (P = 0.7) in the two groups, respectively. Overall incidence of adverse events was 19.8% and 10.9% (P = 0.06) in the group of patients aged < 65 and ≥65 years. Incidence of nausea, vomit, abdominal pain, dehydration and headache was 3.1 vs. 3.0% (P = 0.9), 9.9 vs. 5.9% (P = 0.2), 0.8 vs. 0.0% (P = 0.3) 2.3 vs. 0.0% (P = 0.1) and 2.3 vs. 0.0% (P = 0.1), in the group of patients aged <65 and ≥65 years, respectively. No serious adverse events or deaths occurred in any of the two groups.CONCLUSION:In this post-hoc analysis, we did not find any substantial difference in the safety profile of NER1006 in the elderly compared to younger patients. Given the observational nature of our study, an assessment of blood electrolyte or creatinine was not feasible. Nevertheless, no clinical event attributable to electrolyte imbalance or dehydration was observed in any patient. These results confirm the safety of this product even in the elderly and in a real-life setting.
Journal Article
145 Effectiveness and Tolerability of Very Low-Volume Preparation for Colonoscopy: A Prospective, Multicenter Observational Study
by
Virgilio, Clara Maria
,
Manganaro, Michele
,
Sferrazza, Sandro
in
Colon
,
Colonoscopy
,
Multivariate analysis
2019
INTRODUCTION:The effectiveness of bowel cleansing is essential for a quality colonoscopy since it affects diagnostic accuracy and adenoma detection rate. This study aimed to assess the effectiveness and tolerability of NER1006, a novel 1L PEG preparation, compared to 4 and 2 L PEG solutions in a real-life setting.METHODS:All in- and out-patients scheduled for a screening, surveillance or diagnostic colonoscopy, after an afternoon only or afternoon/morning 1, 2 or 4L PEG-based preparation were consecutively enrolled from September 2018 to February 2019 in 5 Italian centres. Bowel cleansing was assessed through the Boston Bowel Preparation Scale (BBPS), a bowel cleansing success was defined as a total BBPS ≥6 with a partial BBPS ≥2 in each segment and a high-quality cleansing of the right colon as a partial BBPS = 3. Tolerability was evaluated through a semi-quantitative scale with a score ranging from 1 to 10.RESULTS:1289 patients meeting inclusion criteria were enrolled in the study. Of these, 490 performed a 4L PEG preparation, 566 a 2L PEG cleansing and 233 a 1L PEG preparation. Overall, bowel cleansing by BBPS was 6.3 ± 1.5, 6.2 ± 1.5 and 7.3 ± 1.5 (P < 0.001) for 4L, 2L and 1L PEG preparation respectively. Cleansing success was achieved in 72.4%, 74.5% and 90.1% (P < 0.001), while high-quality cleansing of the right colon in 15.5%, 11.7% and 39.5% (P < 0.001) for 4L, 2L and 1L PEG preparation groups, respectively. The 1L preparation was the most tolerated compared to the 2 and 4L PEG solutions, with an average score of 7.8 ± 1.7 vs 7.1 ± 2.0 and 7.3 ± 2.0 (P < 0.001) respectively, in the absence of serious adverse events. At multivariate analysis, age (OR = 0.98, 95% CI = 0.97–0.99; P = 0.02), absence of diabetes (OR = 1.51, 95% CI = 1.01–2.25; P = 0.04), adequate cleansing at previous colonoscopy (OR = 2.37, 95% CI = 1.37–4.09; P = 0.002), afternoon-morning split regimen (OR = 2.52, 95% CI = 1.65–3.83; P < 0.001), low-fiber diet for at least 3 days preceding colonoscopy (OR = 2.31, 95% CI = 1.61–3.31; P < 0.001), colonoscopy within 5 hours after the end of preparation (OR = 2.16, 95% CI = 1.30–3.60; P = 0.003) and tolerability score (OR = 1.22, 95% CI = 1.14–1.31; P < 0.001) were independently associated with bowel cleansing success.CONCLUSION:The novel 1L PEG-ASC solution (NER1006) presents greater effectiveness compared to higher-volume PEG preparation in terms of overall bowel cleansing and high-quality cleansing of the right colon with the advantage of better tolerability respect to comparators.Table 1.Univariate and multivariate analysis showing factors independently associated with bowel cleansing success
Journal Article
Microbiota Gut–Brain Axis in Ischemic Stroke: A Narrative Review with a Focus about the Relationship with Inflammatory Bowel Disease
by
Pellegatta, Gaia
,
Anderloni, Andrea
,
Maida, Marcello
in
Aging
,
Alzheimer's disease
,
Blood pressure
2021
The gut microbiota is emerging as an important player in neurodevelopment and aging as well as in brain diseases including stroke, Alzheimer’s disease, and Parkinson’s disease. The complex interplay between gut microbiota and the brain, and vice versa, has recently become not only the focus of neuroscience, but also the starting point for research regarding many diseases such as inflammatory bowel diseases (IBD). The bi-directional interaction between gut microbiota and the brain is not completely understood. The aim of this review is to sum up the evidencesconcerningthe role of the gut–brain microbiota axis in ischemic stroke and to highlight the more recent evidences about the potential role of the gut–brain microbiota axis in the interaction between inflammatory bowel disease and ischemic stroke.
Journal Article
Gastric Syphilis Presenting as a Nodal Inflammatory Pseudotumor Mimicking a Neoplasm: Don’t Forget the Treponema! Case Report and Scoping Review of the Literature of the Last 65 Years
2023
Despite the fact that gastric syphilis is considered rare, it is reported as a type of organic involvement that is present in a large proportion of secondary syphilis cases, even though gastritis presenting with symptoms is extremely rare. Clinical, radiological, and endoscopic findings are non-specific and frequently mimic the symptoms of gastric adenocarcinoma or lymphoma, making diagnosis difficult. Immunostaining is required for this diagnosis. We would like to emphasize the importance of being suspicious of GS when a gastric mass exhibits the histologic features of an inflammatory pseudotumor (IPT), as previously reported for nodal IPT caused by luetic infection. We described a 56-year-old man who presented to the oncology department with a 3-month history of anorexia, epigastric pain, nausea, vomiting, and weight loss, as well as an initial radiological and endoscopic suspicion of gastric adenocarcinoma, in which immune staining allowed us to diagnose GS. In addition, we conducted an updated scoping review of the scientific literature to show the clinical, laboratory, and therapeutic findings in GS patients over the last 65 years.
Journal Article
A Case of Foreign Body in the Biliary Tree and the Challenge of Hypereosinophilia
by
Fasulo, Ernesto
,
Maida, Marcello
,
Mandarino, Francesco Vito
in
Abdomen
,
Bile ducts
,
Case reports
2023
In all reported cases of foreign body migration or impaction in the biliary tree, there is no mention of the presence of hypereosinophilia among the laboratory findings. This could possibly be attributed to the local tissue reaction caused by the impacted foreign body. Here, we present our experience with the removal of a screw from a surgical retractor that became lodged in the common bile duct (CBD) and migrated in a patient who had previously undergone a left lateral hepatectomy for hepatic hydatidosis. The imaging was not sufficient to make a diagnosis, and the interpretation of hypereosinophilia in such a case could pose a challenge.
Journal Article
An Unusual Presentation of Crohn’s Disease Diagnosed Following Accidental Ingestion of Fruit Pits: Report of Two Cases and Review of the Literature
2021
The clinical course of Crohn’s disease (CD) is often complicated by intestinal strictures, which can be fibrotic, inflammatory, or mixed, therefore leading to stenosis and eventually symptomatic obstruction. We report two cases of subclinical CD diagnosed after fruit pit ingestion, causing bowel obstruction; additionally, we conducted a narrative review of the scientific literature on cases of intestinal obstruction secondary to impacted bezoars due to fruit pits. Symptoms of gastrointestinal bezoars in CD patients are not diagnostic; and the diagnosis should be based on a combined assessment of history, clinical presentation, imaging examination and endoscopy findings. This report corroborates the concept that CD patients are at a greater risk of bowel obstruction with bezoars generally and shows that accidental ingestion of fruit pits may lead to an unusual presentation of the disease. Therapeutic options in this group of patients differ from the usual approaches implemented in other patients with strictures secondary to CD.
Journal Article
Evaluation of main functional dyspepsia symptoms after probiotic administration in patients receiving conventional pharmacological therapies
by
Pistone, Dario
,
Milazzo, Giuseppe
,
Aragona, Salvatore
in
Abdominal Pain
,
Clinical Research Report
,
Dyspepsia - diagnosis
2021
Objective
Postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS) are the two main forms of functional dyspepsia (FD). Probiotics are a promising therapy for FD, but current data remains heterogeneous. This work aims to evaluate a probiotic combination of Lacticaseibacillus rhamnosus LR04 (DSM 16605), Lactiplantibacillus pentosus LPS01 (DSM 21980), Lactiplantibacillus plantarum LP01 (LMG P-21021), and Lactobacillus delbrueckii subsp. delbruekii LDD01 (DMS 22106), alone or together with other pharmacological therapies, for clinical improvement of symptoms associated with FD.
Methods
Patients with FD were enrolled and divided into two groups: PDS and EPS. Probiotic alone or combined with prokinetics, antacids, or proton-pump-inhibitors were administered for 30 days. A progressive-score scale was used to evaluate symptoms in all patients at the beginning of the trial and at 15 days after the end of treatment.
Results
A cohort of 2676 patients were enrolled (1 357 with PDS; 1 319 with EPS). All patients showed significant improvements in dyspeptic symptoms following treatment. In patients with PDS, probiotic alone resulted in the lowest prevalence of symptoms following treatment, while patients with EPS showed no clear between-treatment differences.
Conclusions
Dyspeptic symptoms were reduced following treatment in all patients.
Journal Article
Could Chronic Idiopatic Intestinal Pseudo-Obstruction Be Related to Viral Infections?
by
Pellegatta, Gaia
,
Anderloni, Andrea
,
Maida, Marcello
in
Abdomen
,
Chicken pox
,
Clinical medicine
2021
Chronic idiopathic intestinal pseudo-obstruction (CIIPO) is a disease characterized by symptoms and signs of small bowel obstruction in the absence of displayable mechanical obstruction. Due to the known neuropathic capacity of several viruses, and their localization in the intestine, it has been hypothesized that such viruses could be involved in the pathogenesis of CIIPO. The most frequently involved viruses are John Cunningham virus, Herpesviridae, Flaviviruses, Epstein–Barr virus and Citomegalovirus. Therefore, the present narrative review aims to sum up some new perspectives in the etiology and pathophysiology of CIIPO.
Journal Article
Impact of systematic diabetes screening on peri-operative infections in patients undergoing cardiac surgery
2024
Detection of high glycated hemoglobin (A1c) is associated with worse postoperative outcomes, including predisposition to develop systemic and local infectious events. Diabetes and infectious Outcomes in Cardiac Surgery (DOCS) study is a retrospective case–control study aimed to assess in DM and non-DM cardiac surgery patients if a new screening and management model, consisting of systematic A1c evaluation followed by a specialized DM consult, could reduce perioperative infections and 30-days mortality. Effective July 2021, all patients admitted to the cardiac surgery of IRCCS ISMETT were tested for A1c. According to the new protocol, glucose values of patients with A1c ≥ 6% or with known diabetes were monitored. The diabetes team was activated to manage therapy daily until discharge or provide indications for the diagnostic-therapeutic process. Propensity score was used to match 573 patients managed according to the new protocol (the Screen+ Group) to 573 patients admitted before July 2021 and subjected to the traditional management (Screen−). Perioperative prevalence of infections from any cause, including surgical wound infections (SWI), was significantly lower in the Screen+ as compared with the Screen− matched patients (66 [11%] vs. 103 [18%]
p
= 0.003). No significant difference was observed in 30-day mortality. A1c analysis identified undiagnosed DM in 12% of patients without known metabolic conditions. In a population of patients undergoing cardiac surgery, systematic A1c evaluation at admission followed by specialist DM management reduces perioperative infectious complications, including SWI. Furthermore, A1c screening for patients undergoing cardiac surgery unmasks unknown DM and enhances risk stratification.
Journal Article
A quality improvement program to reduce surgical site infections after cardiac surgery: A 10-year cohort study
by
Campanella, Maria
,
Mularoni, Alessandra
,
Mattina, Alessandro
in
Aged
,
Cardiac surgery
,
Cardiac Surgical Procedures - adverse effects
2025
To assess trends in surgical site infection (SSI) incidence in cardiosurgery following a quality improvement initiative in infection prevention and control (IP&C).
This is a historical cohort study encompassing a 10-year surveillance period (2014–2023) in a cardiosurgical department in a multi-organ transplant center. The study encompassed three periods: a baseline period (Phase_1: January 2014-December 2018); an implementation phase covering quality improvement initiatives targeting various aspects of IP&C including organizational factors, pre-operative, intra-operative, post-operative measures, and post-hospitalization care (Phase_2: January 2019-June 2021); a post-implementation phase (Phase_3: July 2021-September 2023). A general linear mixed model was used to assess differences in SSI rates between distinct phases, adjusted for length of hospitalization, American Society of Anaesthesiologists (ASA) physical status classification, and Diagnostic-Related Groups (DRG) weight. The latter two were used as random effects. Results are reported as odds ratios [OR] with 95% confidence interval [CI].
All cardiac surgery patients were included (n = 5851). A total of 208 patients developed SSI (3.5 %). SSI incidence for phase_1, phase_2 and phase_3 were 4.5 %, 4.1 %, and 1.2 %, respectively. The mixed model regression analysis indicated that, compared with the reference period (Phase1), SSI risk did not drop during the implementation phase (OR 0.81, 95 % CI 0.59–1.13, P < 0.001 vs. reference period). A decrease in SSI risk was observed during the post-implementation phase (OR 0.19, 95 % CI 0.11–0.32)
A quality improvement initiative encompassing measurements at all levels potentially impacting SSI risk was implemented over a 2.5 years period. While no risk reduction was observed during the implementation phase, a significant reduction in SSI risk took place in the post-implementation phase.
This study suggests that considerable time may be required to achieve a substantial SSI risk reduction. We assume this may be attributed to the time required to achieve appropriate adherence with IP&C protocols.
Journal Article