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Objective: This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis. Background: Recently, a new antimesenteric, functional, end-to-end, handsewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD). Methods: Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months. Results: In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P ¼ 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P ¼ 0.2), and 18% versus 30.2% after 24 months (P ¼ 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P ¼ 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P ¼ 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes. Conclusions: This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues. ClinicalTrials.gov ID NCT02631967.

Colonoscopy is usually performed with the one-handed technique (1HT), although several countries and operators still adopt the two-handed technique (2HT). It is still uncertain whether the 1HT can improve the quality outcomes of colonoscopy. We performed a systematic review with meta-analysis to explore the quality outcomes in patients undergoing 1HT or 2HT colonoscopy.We performed a systematic review with meta-analysis to compare the pooled rates of adenoma detection rate (ADR), cecal intubation rate (CIR), cecal intubation time (CIT), and withdrawal time (WT), in patients undergoing 1HT or 2HT colonoscopy via PubMed/EMBASE, SCOPUS, and Cochrane databases. The primary outcome was the pooled rate of ADR and CIR. CIT and WT were also assessed. Pooled odds ratio (OR), standard mean differences (SMD), and 95% confidence intervals (CI) were calculated using fixed or random-effect models.Five studies (15,763 patients) met the inclusion criteria. The pooled ADR was not significantly different between the two techniques (OR 1.10; 95% CI 0.88-1.39; p=0.16), and CIR was not significantly different in 1HT from 2HT (OR 0.757; 95% CI 0.55-1.02; p=0.07), with no significant heterogeneity. Furthermore, no significant differences were seen for CIT (SMD 0.95; p=0.62) and WT (SMD 0.58; p=0.74).The 1HT colonoscopy does not add relevant improvement in the quality and efficacy of colonoscopy.

Golimumab is a new anti-TNF-alpha monoclonal antibody for patients with ulcerative colitis. To assess the short- and long-term effectiveness and safety of golimumab in daily clinical practice and to identify predictors of response. Consecutive patients treated with golimumab in 22 Italian centers were enrolled. Clinical, laboratory, and endoscopic data were prospectively collected before and during treatment. A subgroup of patients completed a questionnaire to assess personal satisfaction with a golimumab autoinjector system. A total of 196 patients were included. After 3 months, 130 patients were responders (66.3%) and showed significant reductions in mean partial, total, and endoscopic Mayo scores and in mean ESR, C-reactive protein, and fecal calprotectin levels (p

Different types of vasculitis can occur in patients with inflammatory bowel disease [IBD], but large vessels vasculitis seems to be the most prevalent. Indeed, the presence of both Crohn's disease [CD] and Takayasu's arteritis [TAK] has previously been reported, with higher prevalence in young women between the second and the third decade of life. This article aims to provide clinicians with an accurate picture of the most common clinical features and current treatment strategy for patients with both CD and TAK.We described the coexistence of CD and TAK in three young women and also performed an extensive literature review about the association of these two immune-related disorders. Research on PubMed server was performed typing the terms "Takayasu's arteritis and inflammatory bowel disease", "Takayasu's arteritis and Crohn's disease", and "Takayasu's arteritis and Ulcerative colitis".Although the association of CD with TAK is uncommon, due to the severity of both diseases, concomitance in the same patient may significantly complicate the diagnostic and therapeutic work-up. In addition, since TAK can compromise intestinal vasculature, it may possibly exacerbate the clinical course of patients with IBD. All patients we reported underwent surgery due to IBD complications and two of them started biological therapy with different outcomes.Early detention of these conditions has a great importance for both gastroenterologists and immunologists, for ensuring a tailored multidisciplinary management, possibly in order to identify a common therapy for these two immune-related disorders.

BACKGROUND AND AIM Infective issues about anti-tumor necrosis factor (TNF)-α agents in inflammatory bowel disease (IBD) remain controversial, especially when compared with nonbiological treatments. This study aimed to evaluate the incidence and prevalence of several infections in anti-TNF-α-exposed patients compared with nonbiological treatments. METHODS All naive IBD subjects treated with anti-TNF-α and matched nonbiologic-exposed patients were included. RESULTS Among 3453 patients in the database, 288 anti-TNF-α-exposed subjects and 288 nonbiologic-exposed IBD controls met inclusion criteria. Fifty-eight infections (20.1%) occurred during anti-TNF-α treatment versus 23 (8%) in the matched group (odds ratio [OR] 2.9, P

The recurrence of Crohn's Disease after ileo-colonic resection is a crucial issue. Severe endoscopic lesions increase the risk of developing early symptoms. Prevention and treatment of post-operative Endoscopic Recurrence (ER) have been studied with conflicting results. We compare effi cacy of azathioprine (AZA) vs. high-dose 5-aminosalicylic acid (5-ASA) in preventing clinical recurrence and treating severe post-operative ER.We performed a 1-year multicenter randomized double-blind double-dummy trial. Primary end-points were endoscopic improvement and therapeutic failure (clinical recurrence or drug discontinuation due to lack of efficacy or adverse events) 12 months after randomization. We also performed a post-trial analysis on symptomatic and endoscopic outcomes 10 years after the beginning of the trial, with a median follow-up of 60 months.Therapeutic failure occurred in 8 patients (17.4%) within 12 months from randomization, with no significant difference between patients treated with 5-ASA (20.8%, 5 patients) and those with AZA (13.6%, 3 patients). Therapeutic failure was due to clinical recurrence in the 5-ASA group and to adverse events in the AZA group. Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group. No serious adverse event was recorded. At the post-trial analysis (median follow-up 60 months), 47.8% (22/46) of patients experienced clinical recurrence: 54.2% (13/24) in the 5-ASA group and 40.9% (9/22) in the AZA group, p=0.546. Patients treated with AZA had lower risk of drug escalation. Clinical recurrence was associated with smoking (p=0.031) and previous surgery (p=0.003).Our trial indicates that there was no difference in terms of treatment failure between 5-ASA and AZA in patients with severe ER. The main limit of AZA is its less favorable safety profile.

The last 4 months have radically changed the world: the novel coronavirus, named severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2,1 is determining probably the most dramatic health and human crisis that every human being can remember: collapsed hospitals, arrested economy, and above all broken lives. But some of these lives have been destroyed by a passion, a mission: being a doctor, even in the time of COVID-19. Thousands of doctors have been infected during the outbreak, and many of them died attempting to save others. Every where men, women, more or less young, each of them honoured being a doctor until their last breath. Until the end of March, China, the first country affected by SARS-CoV-2, experienced 23 healthcare workers’ death.2 In Italy, 127 doctors …

Background While mucosal (MH) and transmural healing (TH) predict relevant clinical outcomes in Crohn’s disease (CD), little is known about the real significance and clinical impact of deep remission (DR). The aim of this study was to better explore the concept of DR, towards a direct correlation between MH, TH and biomarkers. Methods A real-world observational longitudinal study was performed to evaluate the rate of clinical remission (CR), MH and TH, and the fecal calprotectin (FC)/C-reactive protein (CRP) levels in all consecutive patients with CD undergoing maintenance treatment with biologics. A ROC curve was constructed to define the best FC and CRP cut-offs associated with MH and TH. Finally, CD patients achieving CR, MH and TH, in association with the target FC and CRP values, were considered in DR. Results Among, 118 CD patients, CR, MH and TH were achieved in, 74 (62.7%), 52 (44.1%) and, 38 patients (32.2%), respectively. After, 2 years, the mean FC levels decreased from, 494 ±, 515.4 μg/gr to, 260 ±, 354.9 μg/gr (p Conclusion A FC cut-off of, 94 μg/gr and a normal CRP could be included in the definition of DR in association with CR, MH and TH. Thus, DR can be achieved in approximately, 30% of CD patients during maintenance treatment with biologics.

Background Altered body composition may negatively impact on the clinical outcome and quality of life of patients with IBD. Sarcopenia, defined as a progressive loss of skeletal muscle mass and function, is commonly observed in patients with IBD and can be reliably assessed by computed tomography (CT) which allows accurate and reproducibile quantification of both abdominal adipose tissues (subcutaneous and visceral), as well as skeletal muscles. We aimed to assess the prevalence of sarcopenia in Crohn’s disease (CD) patients undergoing contrast-enhanced CT(CECT). We further investigated the associations of sarcopenia with visceral fat parameters, disease severity and surgery Methods 40 CD patients (22F, aged 44±16 yrs; BMI 20.8±3.7) who underwent CECT for clinical assessment were retrospectively enrolled. CECT was performed using a 64-rows multi-detector equipment after i.v. injection of non ionic iodinated contrast media with a tailored scan delay. Demographic and clinical data were collected at the date of abdominal CT. Clinical outcome included the rate of surgery within one year. The skeletal muscle index (SMI) at the level of third lumbar vertebra was used to assess sarcopenia defined as a SMI Results Mean duration of disease was 117 months ± 84. Most patients 60% had a moderate-severe clinical activity based on Harvey Bradshaw index (HBI) >8, whereas 35% had a mild activity (HBI 5–7) and 5% were in remission (HBI Conclusion Approximately 42.5%CD patients were sarcopenic. Female sex and low BMI were significantly associated with sarcopenia but this latter did not correlate with the clinical outcome

The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD) was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab and five for adalimumab) have been approved and licensed by the European Medicines Agency. Biosimilars present great potential in terms of cost saving and possible consequential reinvestment in the health care system. The increasing knowledge about the process of biosimilar development and use in IBD and the publication of many prospective clinical studies and real-life clinical experiences have progressively changed the point of view of IBD physicians. In the present position paper, the Italian Group for the Study of Inflammatory Bowel Disease present and discuss their updated statements and positions on this topic, with emphasis on the concepts of biosimilarity and extrapolation across indications, safety and immunogenicity, interchangeability and switching, automatic substitution, and, finally, patient education about biosimilars.

INTRODUCTION AND AIM: The transitional process of young patients affected by inflammatory bowel disease from pediatric to adult care is a crucial step. Our study aimed to investigate the 1-year success outcome of this transitional process. METHODS: From 2013 to 2018, we evaluated the transitional process of patients with Crohn's disease or ulcerative colitis. For each patient, the following parameters 12 months before and 12 months after the transition were evaluated: Body Mass Index, disease activity and smoker status, number of outpatient visits and the pharmacological therapy, the number of disease exacerbations, hospitalizations and surgical interventions. RESULTS: We enrolled 106 patients with IBD. No statistically significant difference was found between patients' Body Mass Index before and after transition. There was a significant reduction in the number of exacerbations and hospitalizations in the 12 months post-transition (pre-transition exacerbations: 0.74 ± 0.79, post-transition exacerbations: 0.35 ± 0.57, p

Metabolic syndrome (MS) and hepatic steatosis (HS) have been described in patients with celiac disease (CD) after starting a gluten-free diet (GFD), but data on predictive factors for these conditions are scarce. Recently, the patatin-like phospholipase domain-containing protein 3 (PNPLA3) rs738409 has been identified as a key factor for HS development in the general population. The aim of the study was to evaluate the role of PNPLA3 rs738409 in the development of MS and HS in CD patients after starting GFD. Between June 2014 and September 2016, we consecutively enrolled CD patients with HS, while those without steatosis served as a control group. All patients underwent anthropometric and serologic investigations, ultrasonography (US) to assess the degree and severity of HS, and genotyping of the PNPLA3 rs738409 polymorphism. Finally, 370 subjects were enrolled (136 with and 234 without HS). At genotyping assays, the CC genotype was found in 194 subjects (52.4%), the CG genotype in 138 subjects (37.3%), and the GG genotype in 38 subjects (10.2%). At binary logistic regression, only CG and GG alleles were predictive for the development of HS (odds ratio (OR) 1.97, p &lt, 0.01 for CG and OR 6.9, 0.001 for GG). Body mass index (BMI) (OR 3.8, 0.001) and waist circumference (OR 2.8, p = 0.03) at CD diagnosis were the only independent factors for the development of MS. Intergroup comparisons showed that the severe grade of HS was more frequently observed in GG than in CC carriers (74% vs. 11.3%, p &lt, 0.001, OR 21.8). PNPLA3 CG and GG carriers with CD have a higher susceptibility to hepatic steatosis, but not to metabolic syndrome. Moreover, patients with GG alleles display more severe forms of HS based on ultrasound.