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Background Ulcerative colitis (UC) is a chronic inflammatory disorder with an unknown etiology1. Over recent years, a growing body of evidence has been pinpointing gut virome dysbiosis as a fundamental component in its progression2, although its role during the early phases of chronic inflammation is far from being fully defined. Therefore, we sought to investigate the role of a virome-associated protein encoded by the Orthohepadnavirus genus, the Hepatitis B virus X protein (HBx)3, during UC aetiopathogenesis. Methods HBx positivity of UC patient-derived blood and gut mucosa was assessed by RT-PCR and Sanger sequencing correlated with clinical characteristics by multivariate analysis. Transcriptomics was performed on HBx-overexpressing endoscopic biopsies from healthy donors. C57BL/6 mice underwent intramucosal injections of liposome-conjugated HBx-encoding plasmids or the control. Multidimensional flow cytometry analysis was performed on colonic samples from HBx-treated and control animals. Transepithelial electrical resistance measurement, proliferation assay, ChIP-Seq, and RNA-Seq were performed on in vitro models of the gut barrier. Results HBx was detected in about 45% of patients with UC (Figure 1) and found to induce colonic inflammation in mice (Figure 2A-2D), while its silencing reverted the colitis phenotype in vivo (Figure 2E-2H). HBx acts as a transcriptional regulator in epithelial cells (Figure 3), provoking barrier leakage and altering inflammatory response (Figures 3 and 4). Conclusion This study paves the way for the understanding of the aetiopathogenesis of UC and provides a brand-new standpoint that looks at the virome as a target for tailored treatments, possibly leading to an entirely new approach to therapeutic intervention. References: 1. Massimino L, Lamparelli LA, Houshyar Y, et al. The Inflammatory Bowel Disease Transcriptome and Metatranscriptome Meta-Analysis (IBD TaMMA) framework. Nat Comput Sci 2021;1:511–5. doi:10.1038/s43588-021-00114-y 2. Ungaro F, Massimino L, D’Alessio S, et al. The gut virome in inflammatory bowel disease pathogenesis: From metagenomics to novel therapeutic approaches. United European Gastroenterol J 2019;7:999–1007. doi:10.1177/2050640619876787 3. Ungaro F, Massimino L, Furfaro F, et al. Metagenomic analysis of intestinal mucosa revealed a specific eukaryotic gut virome signature in early-diagnosed inflammatory bowel disease. Gut Microbes 2019;10:149–58. doi:10.1080/19490976.2018.1511664

Background Prevention of postoperative recurrence (POR) in Crohn’s disease (CD) after ileo-colonic (IC) resection is still a highly debated topic. Prophylactic immunosuppression after surgery is currently recommended in presence of at least one clinical risk factor (RF). Due to drug-related adverse events and the relative high cost of biologics, we aimed to determine whether prevention of POR can be postponed and guided by endoscopy in CD patients with only one RF. Methods A multicentre retrospective study was conducted in 12 IG-IBD Italian centres. CD patients with only one RF for POR, including previous intestinal resection, extensive small intestine resection (>50 cm), fistulising phenotype, history of perianal disease, or active smoking were considered. Patients who performed a colonoscopy between 6 to 12 months after curative IC resection were included. Two groups were formed based on whether immunosuppressive therapy was started immediately after surgery (prophylaxis group) or guided by endoscopy (observation group). Primary endpoints were the rates of any endoscopic recurrence (Rutgeerts ≥i2a) and severe endoscopic recurrence (i4) within 12 months after surgery. Secondary outcomes were clinical recurrence (HBI≥5) rates at 6, 12 and 24 months after surgery. Results A total of 195 patients were enrolled. Out of all, 61 (31.3%) received immunoprophylaxis at a median time of 32 days [IQR 26-55] after surgery (n=14 infliximab, n=37 adalimumab, n=7 azathioprine, n=3 ustekinumab). Baseline patient characteristics are detailed in Table 1. Particularly, risk factors for POR were homogeneously distributed between the 2 groups. Colonoscopy was performed after a median time of 8 months [IQR 6-11]. No differences between immunoprophylaxis and endoscopy-driven approach was found regarding any endoscopic recurrence (36.1% in prophylaxis group vs 45.5% in observation group, p=0.10) and severe endoscopic recurrence (9.8% in prophylaxis group vs 15.7% in observation group, p=0.15). In 32 patients with a second colonoscopy at a median time of 30.5 months [IQR 22-43.75] after surgery, any recurrence and severe recurrence rates were also similar (p=0.55 and p=0.43, respectively). Early clinical recurrence at 6 months was reported in 23.4% of patients on immunoprophylaxis vs 31.5% who were not (p=0.43). Clinical recurrence rates between prophylaxis and observation group were also similar at 12 months (17.9% vs 34.8%, respectively, p=0.09) and at 24 months (17.9% vs 24.1%, respectively, p=0.63). Conclusion In CD patients with only one RF for POR, immediate immunoprophylaxis after curative IC resection does not decrease the rate of early clinical and endoscopic recurrence. Prospective and larger studies are needed to confirm our results.

Background Intestinal ultrasound (IUS) is accurate to assess endoscopic activity in ulcerative colitis (UC). The Milan ultrasound criteria (MUC) is a validated scoring system to assess and grade endoscopic activity in UC. The most accurate cutoff value for MUC was > 6.2 for endoscopic activity (defined as a Mayo endoscopic score, MES ≥ 2). The aim of this study was to assess the predictive value of IUS and MUC for treatment response in a longitudinal cohort, using colonoscopy (CS) as reference standard. Methods Consecutive active UC patients starting biologic therapy were included. All patients underwent CS, IUS, clinical and faecal calprotectin (FC) evaluations prior commencing a biological therapy, and within one year (mean 9.4 months). In addition, patients were evaluated by IUS, clinical and FC assessments at week 12. The primary objective was to evaluate whether ultrasound improvement (defined as MUC ≤ 6.2) at week 12 predicted endoscopic improvement at reassessment (defined as MES ≤ 1). Endoscopic remission was defined as MES = 0. Results Forty-nine patients were included (59% under infliximab, 29% under vedolizumab, 8% under adalimumab, 4% under ustekinumab). MUC and MES correlated at reassessment (r= 0.767, p < 0.001). Ultrasound improvement at week 12 was the only independent predictor for MES ≤ 1 and MES = 0 at reassessment (OR 5.80, p = 0.010; OR 10.41, p = 0.041; respectively). Ultrasound improvement at week 12 showed NPV of 96% for detecting MES = 0. A ≥ 2 reduction of the MUC score predicted MES=0 (area under the curve, AUC 0.816). MUC ≤ 4.3 was the most accurate cut-off value for MES = 0 (AUC 0.876). The responsiveness ratio of Guyatt for the MUC was 1.73 and the standardized effect size ratio was 1.6. Both these values > 0.8 indicate a large effect of responsiveness for the MUC. Conclusion MUC is highly accurate to monitor treatment response. Ultrasound improvement after the induction period may predict long-term endoscopic response. The MUC may be used both in clinical trials and routine practice.

Background Recently, the European Crohn’s and Colitis Organisation (ECCO) Consensus on Quality-of-Care (QoC) Standards proposed essential criteria on the structure of units who manage patients with inflammatory bowel disease (IBD)1. The E-QUALITY taskforce investigated whether there is a gap between the given recommendations and the real-world structure of IBD units across ECCO-affiliated countries. Methods The E-QUALITY task force developed a web survey accessible to all institutions affiliated to ECCO across Europe. Each institution was invited by email to participate. Only one delegate per institution was requested to respond to the 48 questions listed in the web questionnaire. A descriptive analysis was done. Results Data were collected from September 2022 to December 2022. One-hundred nineteen institutions from 24 countries responded (Figure 1). Characteristics of the institutions are shown in Figure 2. Overall, 80 (67%) institutions identified their hospital as an IBD Unit, 75 (63%) had identified IBD sub-specialists (4 on average per hospital), 66 (55%) had a dedicated IBD nurse, 69 (58%) had an IBD surgeon, and 92 (77%) had a referral pathway for complex IBD surgery. In 81 (68%) institutions there was a regular MDT discussion of IBD cases. The multidisciplinary team (MDT) included at least one pathologist in 80 (67%) institutions, a radiologist in 86 (72%), a dietitian in 69 (58%), and a stoma specialist in 79 (66%). In 107 (90%) institutions, timely access to another sub-specialist (i.e., dermatologist, rheumatologist) was provided. Paediatric-to-adult transition clinics were available in 66 (55%) institutions. In 77 (64%) institutions, departmental IBD management guidelines were reported however, only 56 (47%) developed and applied quality indicators. Almost all institutions (113, 95%) provide direct contact to patients, mainly by telephone and email, and 105 (88%) provide remote follow-up to their IBD patients. In 111 (93%) institutions, there were facilities to administer intravenous therapies, 103 (86%) had an integrated hospital emergency department, 107 (90%) had inpatient admission rights, and 86 (82%) defined a pathway for early recognition of flares. Collaboration with patients’ associations was present in 99 (83%) of institutions, and a patient database was available in 88 (74%). Lack of dedicated funds, protected time and shortage of personnel were regarded as the three main challenges to achieving and maintaining QoC. Conclusion Our survey has revealed that the structure of IBD units across Europe seems to be consistent with the ECCO standards, although some gaps still exist. ECCO will improve programs and initiatives to help institutions provide standard QoC across countries. References: 1. Fiorino G, Lytras T, Younge L, et al. Quality of care standards in inflammatory bowel diseases: A european crohn's and colitis organisation [ecco] position paper. Journal of Crohn's & colitis 2020;14:1037-48.

Background Acute severe ulcerative colitis (ASUC) is a potentially life-threatening condition, requiring immediate hospitalization. Delayed colectomy is associated with increased risk of post-operative complications. This study aimed to identify early predictors of failure to medical treatment and need for colectomy in patients with ASUC. Methods The Management of Acute Severe ulcerative Colitis (MASC) Audit was an international, prospective, observational, cohort study, in which data on consecutive patients hospitalised for ASUC at participating units over a minimum 6-month period in 2019-20 were collated. The need for surgery during the first 90 days after admission was the primary outcome of the study. Data on all consecutive patients admitted for ASUC at the participating units were prospectively entered in an online secure database. A multivariate regression logistic model was developed to identify early predictors of colectomy. The study was developed by a multidisciplinary panel of collaborators, including gastroenterologists, surgeons, and patients, and it was discussed at the 5th IBD National Study Group of the ECCO. The study was led by the European Society of Coloproctology (https://tinyurl.com/vfwmahva). Results Out of 706 patients included in the database, data from 699 patients from 123 centres located in 32 different countries were included in the analysed (Figure 1). Median age was 38 (IQR, 28-54) years; 265 (38%) patients had a previous admission for UC and 39 (6%) had undergone previous appendicectomy. At admission, 13% patients were on monotherapy with 5-ASA, 19% systemic steroids, and 19% biologic agents. Within 90 days after admission, 258 (37%) patients required surgery: 29.7% received second-line and 1.4% received third-line medical therapy. Overall mortality was 1%. Among those patients requiring surgery, postoperative morbidity was 36% (Table 1). Being a current smoker (OR 2.6, 95%CI 1.2-6.0), previous appendicectomy (OR 6.3, 95%CI 2.1-20.0), previous admission for UC (OR 2.6, 95%CI 1.5-4.4), admission to a surgical unit (OR 9.8, 95%CI 4.3-22.5), type of pre-admission therapy and C-reactive protein levels on day 3 after admission (OR 1.01 per mg/L, 95%CI 1.00-1.01, ROC curve in Figure 2) were independent predictors of failed medical treatment. Conclusion Mortality for ASUC did not exceed 1% in this series. Patients who smoked or had previous appendicectomy were at increased risk of medical failure. These factors seem to challenge the current knowledge on UC course, and the findings merit further investigation. C-reactive protein on day 3 after admission was identified as a potential marker to predict the subsequent need for surgery.

Background Up to 15% of patients with ulcerative colitis (UC) do not respond to medical therapies and ultimately require colectomy for disease control. Baseline endoscopic severity and failure to achieve endoscopic healing, as defined by a Mayo Endoscopic Subscore (MES) ≤ 1, following therapy have been associated with an increased risk of colectomy. Intestinal ultrasound severity, as defined by a Milan ultrasound criteria (MUC) score > 6.2, has been associated with an increased risk of colectomy. The aim of this study is to evaluate and compare MES and MUC in predicting the need for colectomy in patients with UC. Methods This is a double-center prospective observational cohort study. All consecutive adult UC patients between January 2016 and January 2020 requiring colonoscopy received intestinal ultrasound within 20 ± 12 days in a blinded fashion. Colectomies were evaluated during the follow-up. Univariable and multivariable Cox regression analyses were used to identify variables independently associated with colectomy risk. ROC analysis was used to compare baseline MES and MUC scores' performances in predicting colectomy. Results A total of 141 patients were enrolled (Table 1). Overall 13 patients underwent colectomy during 256.41 person-years of observation time. At baseline, patients requiring colectomy had increased mean values of MUC as compared to patients not undergoing surgery (6.84 ± 2.49 vs 10 ± 1.9, p Conclusion Ultrasound severity, as assessed by the MUC score, is superior to endoscopic severity in predicting the need for colectomy in patients with UC. A baseline MUC score of < 7.72 may rule out colectomy risk in UC patients.

OBJECTIVES First aim of study was to compare the diagnostic accuracy of high resolution T2-WI (HRT2-WI) and gadolinium-enhanced T1-weighted image (Gd T1-WI) sequences in quantitative evaluation of vestibular schwannomas (VS). The second one was to determine through qualitative evaluation when Gd-injection should be recommended. METHODS Two observers in consensus retrospectively reviewed 137 magnetic resonance imaging (MRI) scans of patients with histological diagnosis of VS (33 women, 26 men), 116 with both HRT2-WI and Gd T1-WI. The examinations were subdivided in: surveillance (10), pretreatment (30), posttreatment (43), and posttreatment follow-up (33) studies. Quantitative evaluation was based on size measurement of the lesion. Structural details of the lesion, facial nerve course, and involvement of the fundus of the internal auditory canal were assessed for the qualitative evaluation in both sequences. RESULTS No statistically significant changes were demonstrated between size measurement in the HRT2-WI and Gd T1-WI (p = 0.329). Sensitivity, specificity, and accuracy of HRT2-WI in the detection of lesional size were 90.4, 98.9, 92.5%, respectively. HRT2-WI was worse for characterization of structural details in pretreatment, posttreatment, and posttreatment follow-up examinations. HRT2-WI showed better or equal capability for all the groups in the demonstration of the facial nerve course. In the evaluation of the involvement of the fundus of the internal auditory canal, HRT2-WI showed worse results or had a complementary role for the posttreatment and posttreatment follow-up groups, while in the other groups was considered mainly equal or complementary. Only in the surveillance group, HRT2-WI was never worse for all the criteria. CONCLUSION Results for quantitative evaluation were similar in both the sequences. Gadolinium injection can be avoided only in surveillance studies.

Background Intestinal ultrasound (IUS) is accurate and non-invasive to detect and monitor disease activity in Crohn’s disease (CD). The Bowel Ultrasound Score (BUSS= 0.75 × bowel wall thickness + 1.65 × presence (1) or absence (0) of bowel wall flow) demonstrated high accuracy in detecting therapy-related changes, and good correlation with the Simple Endoscopic Score for CD (SES-CD). The most accurate cutoff value for BUSS was 3.52 for endoscopic remission (SES-CD ≤ 2).This study aimed to prospectively evaluate ultrasound remission as a relevant treatment target. Methods Consecutive patients with active CD (SES-CD > 2) starting biologic treatments were included. Patients underwent colonoscopy and IUS at baseline and after 1 year of treatment. Clinical, biochemical and ultrasound assessments were additionaly performed at week 12. Primary outcome was to evaluate whether ultrasound remission at week 12 could predict endoscopic remission at week 54. Endoscopic remission was defined as SES-CD ≤ 2, ultrasound remission was defined by BUSS ≤ 3.52, clinical remission was defined by HBI (Harvey-Bradshaw Index) < 5, and biochemical remission was defined by normalization of C-reactive protein (< 5 mg/L) and fecal calprotectin (three different thresholds were assessed: < 250 µg/g, < 100 µg/g, < 50 µg/g). Results Ninety-three patients were included (8 under infliximab, 40 under adalimumab, 5 under vedolizumab and 40 under ustekinumab). Eighteen patients (19%) and 36 patients (39%) achieved endoscopic remission and ultrasound remission at week 54, respectively. CD patients with ultrasound remission at week 12 were more likely to achieve endoscopic remission (odds ratio [OR] 6.88 [2.14–22.04]; p = 0.001) and ultrasound remission (OR 4.26 [1.61–11.24]; p = 0.003) at week 54. Calprotectin value < 50 µg/g at week 12 predicted endoscopic remission at univariable (OR 3.14 [1.04–9.45]; p = 0.041), but not at multivariable analysis. No other clinical or biochemical variables at week 12 predicted endoscopic and/or ultrasound remission at week 54. Conclusion Ultrasound remission achieved at week 12 may predict long-term endoscopic remission and may be a strategic treatment target, both in clinical practice and in clinical trials.

Background Diagnostic delay is a challenge in inflammatory bowel disease (IBD), more in Crohn’s disease (CD) than in ulcerative colitis (UC). Whether difficult access to healthcare facilities may be a cause of diagnostic delay is debated. Restrictions due to SARS-COV2 pandemic have impacted on the prompt access to hospitals and clinics during 2020. We aimed to investigate if those limitations impacted on diagnosis, presence of IBD-related complications, and the number of hospitalization and surgeries by the first 12 months after diagnosis. Methods We retrospectively analysed all consecutive patients who had access to our tertiary referral centre in Rome, Italy in the period between January 1st, 2019 and December 31st, 2021. We split all patients in three study groups: those who had diagnosis of IBD in 2019 (normal setting, control group), 2020 (severe restrictions for access to our clinic), and 2021 (intermediate restrictions). Delay from symptoms to diagnosis, presence of IBD-related complications at diagnosis, need for hospitalization and/or surgery at diagnosis, and hospitalization and surgery rates in the first 12 months since diagnosis were collected and analysed. Statistically significant differences were set as per p value Results Overall, 6,125 patients accessed to our department in 2019, 4,594 in 2020, and 6,063 in 2021. In the entire period, 89 patients were diagnosed with IBD (17 CD and 14 UC in 2019, 12 and 10 in 2020, and 17 and 19 in 2021). Baseline characteristics are listed in Table 1. Median delay between symptoms and diagnosis did not statistically differ among the 3 groups (7 months in 2020, and 2 months in 2021, compared to controls, p=0.07 and p=0.24 respectively), and among CD and UC patients (p=0.30). No differences were found in hospitalisation at diagnosis (p=0.90 for 2020, and p=0.66 for 2021 compared to controls), and in the rates of IBD-related hospitalization and surgery in the following 12 months since diagnosis (p=0.41 for 2020, 0.81 for 2021 compared to controls). No significant associations were found between CD and UC patients, and no significant association was found between sex, age, type of disease, and localisation of the disease at diagnosis and 12-month outcomes. Conclusion Although on a small population, difficulties in accessing to hospital did not impact on diagnostic delay and further disease course in IBD patients. Further investigation on factors associated with diagnostic delay is needed.

Background Lémann Index (LI) is a well-established validated index to assess cumulative bowel damage in Crohn’s disease (CD). Magnetic resonance imaging and colonoscopy are usually used to measure LI. We assessed the accuracy of bowel ultrasound in assessing LI and its sensitivity to change in a longitudinal cohort of CD patients, in comparison with magnetic resonance imaging. Methods We performed a prospective observational study of 60 patients with active CD. All patients underwent bowel ultrasound, magnetic resonance imaging, and colonoscopy at baseline and at reassessment, within 1 year from treatment with biologics (30 patients were treated with adalimumab, 22 with ustekinumab, four patients with infliximab, and four with vedolizumab). The primary analysis was to determine the correlation between magnetic resonance-based LI and ultrasonography-based LI, both at baseline and at reassessment. Additional analyses established the magnitude of change in LI over time, measured by magnetic resonance imaging and colonoscopy, and its correlation with those in LI measured by bowel ultrasound and colonoscopy. Results The mean values of magnetic resonance-based LI and ultrasonography-based LI at baseline were 6.3 (± 4.8) and 6.4 (± 4.9) respectively, p= 0.39; at reassessment, 5.3 (± 4.6) and 5.5 (± 4.9) respectively, p= 0.30. No differences were observed according to different treatments (Table1). There were significant differences between LI assessed at baseline and LI at reassessment, independently by the imaging tool used for measuring it (p < 0.05). Very high correlations were observed between the magnetic resonance-based LI and ultrasonography-based LI (at baseline, r= 0.964, p < 0.0001; at reassessment, r= 0.970, p < 0.0001) (Figure 1). The magnitude of change in magnetic resonance-based LI correlated with those in ultrasonography-based LI (r= 0.871; p < 0.0001) (Figure 1). Conclusion LI can be measured by bowel ultrasound alternatively to magnetic resonance imaging, without no meaningful change in its value.

Background The use of ustekinumab (UST) and vedolizumab (VDZ) as second line therapy in Crohn’s disease (CD) patients failing tumour necrosis factor alpha inhibitors is still debated. The aim of the study was to compare in a large multicentre observational retrospective cohort, the effectiveness of UST and VDZ as second line therapy as assessed by clinical and objective outcomes including endoscopy and gastro intestinal (GI)-imaging. Methods Clinical response, remission and steroid-free remission at week 26 and 52 were evaluated in a retrospective cohort of CD patients previously experienced TNF-alpha inhibitors (primary or secondary failure, and intolerant). Objective response and remission were evaluated by one or more techniques including ileocolonoscopy, magnetic resonance (MR)/computer tomography (CT) enteroclysis and small bowel ultrasound (US) performed within 3 months before the beginning of the treatment and after one year of therapy. Inverse propensity of treatment weighting (IPTW) and propensity score matching (PMS) methods were used for statistical analysis. Results 470 CD patients (239 UST and 231 VDZ) were included in the study. At week 26 clinical response, clinical remission and steroid free remission were similar between the two groups (Figure 1) At week 52, clinical remission and steroid-free remission rates were significantly higher in VDZ-treated patients (clinical remission: UST 42.5% vs VDZ 55.5%, p=0.01; steroid-free clinical remission UST 40.6% vs VDZ 51.1%, p=0.038; Figure 1). 302 patients (135 UST and 167 VDZ) had objective evaluation of disease activity at baseline and week 52. At week 52 objective response and remission rates were similar between the groups. (Figure 2). Clinical response at week 26 predicted steroid-free remission at week 52 in both UST- and VDZ-treated patients. Safety profiles were similar between the two groups. Conclusion One-year treatment with VDZ was associated with higher rate of clinical remission as compared to UST, but no difference was observed between the two groups when objective outcomes were investigated

Background We assessed the accuracy and the responsiveness to change of Milan Ultrasound Criteria (MUC) in patients with ulcerative colitis (UC), using colonoscopy as the reference standard. Methods We performed a prospective observational study of 49 patients with active UC. All patients underwent bowel ultrasound and colonoscopy at baseline and at reassessment, at week 48, after treatment with biologics (29 patients were treated with infliximab, 14 with vedolizumab, four with adalimumab, two with ustekinumab). Furthermore, patients underwent bowel US also at week 12 and 24. Disease activity was quantified using Mayo endoscopic subscore and MUC. The primary analysis was to determine the accuracy of MUC in identification of endoscopic remission defined as a Mayo endoscopic subscore < 2. Additional analyses established the accuracy of MUC in determining change in lesion severity. Logistic regression was used to examine the relationship between the absence or presence (0/1) of endoscopic remission at reassessment as the dependent variable and possible predictors at week 12 as the independent variables. The model was performed using the stepwise backward method. Results Eighteen patients (37%) got endoscopic remission at reassessment. In Table 1 are summarized endoscopic and ultrasound outcomes achieved at reassessment according to the different treatments. MUC < 6.2 determined endoscopic remission with 83% sensitivity, 84% specificity, 84% accuracy, 75% PVP and 90% PVN (Table 2). MUC was sensitive to change in ulcerative colitis [Guyatt’s responsiveness index: 1.73; standardised effect size ratio: 2.0]. MUC changed significantly from baseline to reassessment [8.72 (7.78−9.14) vs 7.60 (4.71−8.53), p < 0.0001], with the largest drop at week 12 [8.72 (7.82−9.19) vs 7.46 (5.80−7.98), p < 0.0001] (Figure 1). A change of -2 in MUC overtime predicted endoscopic remission at reassessment (AUC 0.806, 95% CI 0.667–0.904; sensitivity 89%, specificity 77%). At multivariable analysis only MUC < 6.2 at week 12 was statistically significantly associated with endoscopic remission at reassessment (Table 3). Conclusion MUC accurately detects endoscopic remission. MUC is a highly responsive, reliable tool for assessing treatment response in patients with ulcerative colitis.

Background Endoscopic post-operative recurrence (ePOR) is common following ileocecal resection (ICR) in patients with Crohn’s disease (CD), reaching up to, 70% at, 1-year. In clinical trials, prophylaxis with anti-TNF therapies demonstrated a decrease in ePOR to around, 20% at, 1-year. Here we aimed to compare the effectiveness of vedolizumab (VDZ) and ustekinumab (UST) to anti-TNFs for preventing ePOR after curative ICR in adults with CD in a real-world setting. Methods This was a retrospective multicenter study, assessing patients with CD >17years who underwent ICR between, 2015–2019, started prophylaxis within six months of surgery, and underwent an ileocolonoscopy ≥ four months after prophylaxis. ePOR (Rutgeerts score ≥ i2 or colonic-segmental-SES-CD≥6) was assessed at, 12, 24, 36-months periods post-surgery. Multivariate logistic regression was used to assess risk factors for ePOR, and IPTW was performed to compare the effectiveness between agents. Results Included, 297 patients [53.9% males, age-at-diagnosis, 24(19–32) years (median;IQR), age-at-ICR, 34(26–43)years (median;IQR), 18.5% current-smokers]. Of these, 17.2% had previous-ICR, 8.1% were biologic naïve, 65.7% anti-TNF experienced, and, 28.6% exposed to, 2 biologics. Overall, 224, 39 and, 34 patients received respectively anti-TNFs, VDZ or UST for prevention of POR. Patients on VDZ and UST were more likely to be biologic experienced or post previous-ICR. ePOR rates for the entire cohort, anti-TNF, VDZ and UST were:, 41.8%, 40.2%, 33%, and, 61.8% at, 12-months, 49.0%, 46.5%, 44.4%, and, 72.4% at, 24- months, and, 48.6%, 47.9%, 44.0% and, 62.5% at, 36-months, respectively. Risk factors for ePOR: past infliximab (Adj.OR =1.73 [95% CI:, 1.01–2.97], p=0.045) or adalimumab (Adj.OR = 2.32 [95% CI:, 1.35–4.01], p=0.002), and technical aspects of anastomosis. After controlling for the disparities between groups by the IPTW method risk of ePOR at, 12-months was comparable between patients on anti-TNFs vs VDZ or anti-TNFs vs UST. However, comparison between VDZ vs UST groups revealed that patients on UST were at a higher risk for ePOR at, 12-months (OR=3.75 [95% CI:, 1.33–10.6]), p=0.012. Conclusion Prevention of ePOR was successful in ~60% of patients at, 12-months period. Patients on prophylaxis VDZ or UST consisted of a distinct, more refractory group with higher rates of ePOR. Post-operative treatment with UST or VDZ resulted in a similar risk of ePOR when compared to post-operative prophylaxis with anti-TNF after controlling for disease severity.

Background In the last year, the severe adult respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic has spread rapidly around the world. The interactions between SARS-CoV-2 and inflammatory bowel disease (IBD) are so far not fully understood. In particular, no studies evaluated the potential role of SARS-CoV-2 on IBD course. Indeed, it is known that viral infections can be act as triggers for IBD flare and it is reasonable that the possible drug discontinuation during SARS-CoV-2 infection could in turn lead to an IBD flare. Methods This was a prospective, observational case-control study. From March 11th 2020 to June 30th 2020 we enrolled IBD patients with proven SARS-Cov-2 infection (“cases”) and IBD patients without SARS-CoV-2 infection matched for sex, age, diagnosis, therapy and clinical activity (“controls”). Cases and controls were followed-up at least for 6 months. Differences between case and control group were tested for significance using the Student’s t test and Fisher’s test, as appropriate. A two-tailed p value < 0.05 was indicative of statistical significance. Results 219 IBD patients (127 UC, 58.0%) with SARS-CoV-2 infection and 219 IBD patients without SARS-CoV-2 infection were enrolled. Table 1 shows baseline features of the population. Among the 122 cases in clinical remission at the time of viral infection, 28 (22.9%) showed a disease flare; this percentage was significantly higher than that observed in controls: 12/137 (8.8%)(p=0.0018). Among patients with disease flare, there were no significant differences between cases and controls group in terms of age (42.3 ± 16.0 vs. 43.1 ± 15.4 years, p=0.44), gender (female 45.7% vs. 48.2%, p= 0.54), use of biologic therapies (p=0.83) and UC or CD diagnosis (p=0.06). Biologic therapy was temporary withdrawn more significantly in cases than in controls (68/202, 33.6% vs. 14/204, 6.9%) (p Conclusion IBD patients with SARS-CoV-2 infection have an increased risk to have a clinical recurrence in short-term in comparison with IBD patients without SARS-CoV-2 infection. This increased risk could be due to the viral infection and/or to the temporary discontinuation of biologic therapies, because of infection.

Background Coronavirus disease 2019 (COVID-19), had two pandemic waves in 2020, respectively in April and November. In the general population, the first wave has been characterized by a higher prevalence in Northern Italy and a higher mortality rate compared to the second one. The aim of this study was to compare the characteristics of IBD patients and negative outcomes of COVID-19 (pneumonia, hospitalization, ventilatory support, death) between the two pandemic waves in Italy. Methods Prospective observational cohort study. Patients with diagnosis of IBD and confirmed SARS-CoV-2 infection were enrolled. Differences between first and second wave were tested for significance using the Student’s t test and Fisher’s test, as appropriate. A two-tailed p value Results We enrolled 937 IBD patients from 47 participating IBD centres across Italy (219 in the first wave, 718 in the second wave). There were no significant differences between the first and the second wave in terms of age (46.3 ± 16.0 vs. 44.1 ± 15.5 years, p=0.06) and gender (female 45.7% vs. 48.2%, p= 0.54). In the first wave, a lower percentage of patients was affected by Crohn’s disease (CD): 92 (42.0%) vs. 399 (55.6%) (p Conclusion IBD patients had higher number of COVID-19 negative outcomes in the first wave than in second wave. In the first wave, a significantly higher percentage of patients were from Northern Italy, but no significant differences in negative outcomes were observed in comparison with those from Central- Southern Italy. Overall, findings in IBD population are coherent with those observed in the general population.

With the increasing age of the general population in developed countries, the management of several chronic diseases becomes more and more complex due to comorbidities. Some, especially inflammatory bowel diseases, formerly believed to belong to the young adult population, have now been recognized as being present at disease onset also in the ageing population, representing medical challenges different from those in the younger population. In the past years, knowledge on this special older population has increased, changing initial beliefs concerning epidemiology and course of disease. In the present review, we will address the most recent evidence concerning their current incidence compared with other age groups, their clinical course, potential risk factors for the development of late-onset IBDs, associated diseases, and cancer risk beyond therapy-related neoplasias.

To evaluate the effectiveness and the frequency of use of a pulsed xenon ultraviolet light-emitting no-touch portable device (PX-UV), applied after perform current cleaning, in reducing environmental bacterial burden and the presence of pathogens on surfaces in the operating rooms at the Policlinico University Hospital of Foggia.Prospective before-and-after study with a follow up duration of four months, from May to August 2019.Two operating rooms of an Orthopaedic and a Neurosurgical ward in a 780-bed university hospital in the District of Foggia, Italy (about 600,000 inhabitants).According to the hygienic standards proposed by the Italian Workers Compensation Authority (ISPESL), the total and the average bacterial load and the presence of six pathogens were evaluated between pre- and post- PX-UV use combined with routine manual cleaning.The PX-UV system was applied at five distinct time points: t1: start of the experiment, t2: after 28 days, t3: after 13 days, t4: after 7 days, and t5: after 8 days (t2-t5: 28 days in total). About 16-min of PX-UV cycle showed significant reduction in the level of environmental contamination by decreasing the mean colony count by 87.5%, compliant with the standard (5lt; X ≤15 CFU per plat). Staphylococcus aureus and Acinetobacter baumannii that had been isolated in some of the samplings before PX-UV were no longer detected after t1, t2 and t5 treatments. Before PX-UV, the mean colony count was similar between t1 and t2 (pgt;0.05); after t3 and t4 treatments, it was lower before t5 in both the Orthopaedic and Neurosurgical operating rooms (= -97% and -75%, respectively; plt;0,01).Implication for practice: PX-UV could supplement the standard cleaning process in reducing the microbial burden in the operating rooms and potentially achieving lower healthcare-associated surgical site infections rates.

Background Pivotal anti-SARS-CoV-2 vaccines clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease (IBD). We aimed to describe the implementation of anti-SARS-CoV-2 vaccines among IBD patients, patients’ concerns before vaccination and side-effect profile of the anti-SARS-CoV-2 vaccines using real-world data. Methods An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of patients’ characteristics, concerns, vaccination status and side-effect profile were analysed using descriptive statistics and logistic regression. Results Among the 3272 IBD patients completing the survey (0.1% of the IBD European population), 79.6% had received at least one dose of the anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Most of the patients (70.6%) were vaccinated with the Pfizer-BioNTech (BNT162b2) vaccine. Patients over 60 years old had a significantly higher rate of vaccination (OR 2.98, 95% CI 2.20–4.03, p Conclusion Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.

Background Patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD) are at increased risk of developing gastrointestinal (GI) malignancies. The aim of this study is to assess the risk of malignancies in IBD patients and the impact of cancer screening according to the ECCO guidelines in a tertiary referral centre. Methods We retrospectively analysed the electronic database of all IBD patients followed by the IBD Centre of Humanitas Research Hospital, Milan, from January 2010 to October 2019, and collected all new diagnoses of solid and haematological tumours since 2010. The annual standardised incidence rate (SIR), rate of mortality and early cancer diagnosis were calculated and a descriptive analysis of drug exposure, disease duration, family history of any cancer, smoking habits was made. Results We included 5239 patients, with a total 19820 patient-years follow-up. Eighty-four malignancies in 81 patients were retrieved, 71 were included in the final analysis (38 CD, 32 UC, 31 females). Average age at tumour diagnosis was 52.9 years (range 19–78). 64% of patients were former or active smokers, 31% had a family history of cancer or IBD. Sixty-two per cent of patients were previously exposed or had 5-ASA at the time of cancer, 40% azathioprine, 43% anti-TNF or vedolizumab. The annual SIR for all kinds of malignancy was 0.358%. GI malignancies were the most frequent (n = 17, 23.9%, 47% UC, 53% in CD). Six over 8 GI tract malignancies in UC patients were found in the colon or rectum (mean disease duration 22.5 years), whereas in CD patients 5/9 were in the small-bowel (mean disease duration 7.0 years). Melanoma and breast cancer (n = 8 each) were the most common non-GI cancers, followed by prostate (n = 7) and bladder (n = 6). No significant difference in incidence was found between CD or UC. Non-Hodgkin lymphomas and leukaemia (3 and 1, respectively) only occurred in CD patients. Other tumours included thyroid (n = 5), lungs (n = 4), testicle (n = 3), ovary (n = 2), kidney (n = 2), head-nose-throat (n = 2), pancreas (n = 1), brain (n = 1), and non-melanoma skin cancer (n = 1). Death occurred in 11% of patients, 8 of them for late stage cancer. Only 2 were related to the concomitant IBD (1 colo-rectal and 1 anal cancer). In patients regularly screened according to the ECCO Guidelines (GI cancer, haematological and skin cancer), there was a significantly higher number of detection of early cancer (28 vs. 1, p = 0.003), although no differences in mortality rates were reported in the two groups (2 vs. 2, p = 0.10). Conclusion The overall incidence of cancer in our cohort was not different from the current literature available. Adherence to the ECCO Guidelines for cancer surveillance improves the detection of early cancer in IBD patients.

Scope: figure out the pregnant women that are affected by Obstructive Sleep Apnea Syndrome ( OSAS), in oreder to recognise precociously possible cases of pypertension during pregnancy and to control precociously possible maternal-fetal implications. Strengthen the correlation between OSAS and gestational Hypertension and other diseases of metabolism to include the ORL evaluation among the preconception surveys to minimise the comorbidity of a programmed pregnancy Materials and methods: We studied during a period of 18 months, 487 pregnant women form the province of Verona. Women with pre-existing hypertension, obesity, patients with previous OSAS diagnosis and over 40 years were excluded from the study. We administered all patients with a questionnaire designed by us on the basis of questionnaires validated by Epworth and Berlin that were modified on the basis of physiological changes ( the weight of the child at birth, term pregnancy, dysmetabolism during pregnancy) and tha areas of origin of the family. Starting from the II trimester of the pregnancy women were subjected to a polysomnography. Results: Involving 97 pregnant women who presented hypertension after the 20th week ( gestational hypertension) 88%were affected by OSAS between moderate and severe ( AHI>= 30). On Statistical analysis the difference between the AHI and the pressure values were higly significant ( p Conclusion: Polysomnography is a cheap test, without any side effects that allows to identify a category of pregnant women that are at risk of developing gestational hypertension.

Background The treatment paradigm for inflammatory bowel disease (IBD) is becoming increasingly diverse and complex. It is suggested that engaging patients through shared decision-making optimises treatment selection in line with clinical need and patient preference and expectations. This patient survey aimed to explore patients’ preferences towards attributes of currently available advanced therapies for IBD as well as the impact of IBD on patients’ quality of life (QoL) across 7 countries in Europe. The demographic profile of the study cohort and findings on the patient-rated impact of IBD on QoL are reported here. Methods An online, cross-sectional survey (October 2020 to January 2021) enrolling adults aged ≥18 years who self-reported having and being previously/currently treated for Crohn’s disease (CD) or ulcerative colitis (UC) was conducted across Europe (France, the UK, Spain, Italy, Belgium, Switzerland and the Netherlands). Patient perspectives on IBD care and preferences regarding specific attributes of existing treatment options were explored using the Carenity platform and via partnerships with local organisations. This descriptive analysis evaluated the demographic and clinical profile of respondents, treatment management and impact on QoL. Results Overall, 686 patients (CD: 360; UC: 326) across 7 countries completed the survey. Among CD and UC patients, respectively, 71.9% and 57.7% were females; mean age (range) was 48.0 (19.0–77.0) and 50.0 (19.0–82.0) years; and mean disease duration (range) was 13.6 (0.2–49.1) and 11.0 (0.1–68.7) years. Overall, 37.5% of CD patients reported fistulising CD, and 9.4% (CD) and 10.1% (UC) of patients had a stoma or pouch; 76.7% (CD) and 78.5% (UC) of patients were being treated for IBD. Approximately 50.0% of patients with IBD were full-time or part-time employed at the time of survey. Abdominal pain, fatigue, and stool frequency were ranked by 83%, 79%, and 73% patients with CD, respectively, as the symptoms most impacting QoL; 79%, 71%, and 61% patients ranked energy status, general well-being and daily activities, respectively, as the most impacted aspects. Abdominal pain, stool frequency and fatigue were ranked by 73%, 72% and 67% patients with UC, respectively, as the symptoms most impacting QoL; the most impacted aspects were similar to those of patients with CD. Patients in both groups prioritised general well-being, energy status and daily activities as aspects for improvement through treatment. Conclusion This large European survey highlights the most impactful symptoms and QoL aspects from the patient perspective. These findings can support clinical decision-making and treatment strategies to improve treatment outcomes and patient QoL.

Background A ‘treat-to-target’ strategy with close monitoring of intestinal inflammation is recommended in Crohn’s disease (CD). Bowel ultrasound (US) is a non-invasive, point-of-care tool to assess CD activity and severity. However, no clear US-based parameters of activity have been identified by using magnetic resonance imaging (MRI) and colonoscopy together as a reference standard. We aimed to investigate whether US parameters could be able to measure CD activity and severity, comparing with the MaRIA and the SES-CD scores. Methods Ileal and/or colonic CD consecutive patients were prospectively assessed by CS, MRE and bowel US. Bowel wall thickening (mm), bowel wall-flow at colour Doppler (BWF: 0 absent; 1 present), bowel wall pattern (BWP: 0 normal; 1 hypoechogenic; 2 hyperchogenic; 3 lost), presence of mesenteric lymph nodes (0 absent; 1 present) and mesenteric hypertrophy (0 absent; 1 present), evaluated at bowel US were compared with CS+MRE findings as a reference standard. Activity was defined by an SES-CD score>2 and/or a MaRIA score>7). Results Sixty CD patients were prospectively enrolled (37% with ileal localisation, 15% with colonic localisation and 48% with ileocolonic localisation). Thirty patients had endoscopically active CD, 34 had radiologically active disease, 37 (62%) had active disease assessed at CS or MRE (SES-CD > 2 or MaRIA score >7 in at least one segment). BWT, presence of BWF, hypoechogenic or lost BWP significantly correlated with endoscopic and radiological activity (OR 4.51, 33.75, and 2.74 respectively, all p < 0.001). The multivariable analysis identified only BWT (per 1-mm increase, OR: 6.56, 95% CI 1.25–34.44, p = 0.026) as an independent predictor for disease activity. The cut-off value of 4.4 mm BWT was identified to distinguish active vs. non-active disease (AUROC 0.905, Sensitivity 81%, Specificity 96%). A significant correlation was found between BWT and MaRIA and SES-CD score (r = 0.768, 95% CI 0.662–0.868, p < 0.0001; r = 0.602, 95% CI 0.409–0.743; p < 0.0001; respectively). Conclusion Bowel US is able to assess and measure disease activity in ileocolonic CD in real-time. BWT correlated very well with the MaRIA score and the SES-CD score. Further studies are needed to confirm these findings and to demonstrate the role of point-of-care US in CD management.

Background Patients with inflammatory bowel diseases (IBD) have an altered quality of life, also due to chronic fatigue (CF). Iron administration is effective in iron deficiency associated with CF in patients with heart failure. Our hypothesis was that iron administration in patients with iron-deficiency could improve CF and quality of life in IBD patients. Methods This was a phase 2, randomised, placebo-controlled, double-blind trial. Adult patients with established IBD diagnosis in clinical remission (HB 13), martial deficiency (ferritin 13) at week 24 and CF remission (MFI-20 Results Forty-six patients were screened, 30 patients completed 24 weeks of treatment (21 Crohn’s disease, 9 ulcerative colitis). Baseline characteristics were not different among the two groups. Between patients treated with ICM vs. PBO, 2/15 patients vs. 0/15 respectively were in CF remission at week 24 (13% vs. 0%, p = 0.46). CF response was observed in 7/15 patients treated with ICM vs. 10/15 patients with PBO (47% vs. 67%, p = 0.46). At week 12, 1/17 vs. 0/17 patients were in CF remission (6% vs. 0%, p = 0.96), and 12/17 vs. 10/17 (71% vs. 59%, p = 0.90) showed CF response. At the study completion, ferritin restoration was found in 12/14 patients (86%) treated with ICM vs. 1/15 (7%) receiving PBO (p < 0.001). No significant differences in terms of anxiety, depression and quality of life restoration were found between the two groups at week 12 and 24. A total number of 69 adverse events (AEs) were reported in 17 patients (37 mild, 31 moderate, 1 severe), only 5 were related to the study treatment (3 nausea, 1 gastric pain, 1 arthralgia), and only 1 (nausea) led to study drug discontinuation. Conclusion Intravenous ICM is not effective in treating CF in IBD patients, with no significant adverse events. ICM was more effective than PBO in restoring ferritin in the majority of IBD patients. Funding This study was funded by the ECCO Vifor Grant 2017.

BACKGROUND. The urea Breath-test is a widely-used method to detect the presence of Helicobacter pylori (HP) infection. Recently, new technologies were introduced, to obtain an immediate test result by continuous breath samples analysis after labeled urea intake. The total test duration is shorter than 20 minutes. METHODS. The study compared two diagnostic methods requiring the administration of EXPIROBACTER (R) (Sofar SpA, Trezzano Rosa, Milan, Italy) 100 mg as a source of labeled urea. Subjects with clinical indication to urea breath test for H. pylori were enrolled. This study was designed to directly compare the accuracy of urea breath test performed with both the classic method and BreathID (R) (Exalenz Bioscience, Inc., Manasquan, NJ, USA). Each patient simultaneously underwent to both tests, to measure the concordance between the results (positive or negative test), minimizing the risks of differences related to the intra- and inter-individual variability. RESULTS. Forty-six subjects were enrolled. Forty-one patients (91.1%) were found negative with both methods and 5 (10.1%) were positive for H. pylori infection in both tests. Correlation between the two methods was excellent(kappa=1.00). BreathID (R) was significantly preferred by patients, with a 7.83 (95% CI: 3.35 to 12.30, P=0.001) difference in mean patient satisfaction, measured by a Visual Analogue Scale (VAS). No adverse event was observed. CONCLUSIONS. Correlation between the two methods was excellent. Moreover, the patient satisfaction, measured by VAS, showed a significantly greater acceptance of BreathID (R) method. This study support the use of a product containing C-13-urea 100 mg and citric acid for immediate determination of HP infection by urea breath test performed with BreathID (R)

A years old man sustained a fracture of the hyoid bone following closed neck injury while weight lifting in the gym Though commonly occurring in association of other neck fractures of the laryngeal skeleton the fracture was isolated Isolated hyoid bone fractures resulting from trauma other than strangulation are very rare and occur more frequently in young men more than in women These fractures are usually managed conservatively with good results as indeed our case was

Introduction Treatment paradigms for Crohn’s disease with perianal fistula (CD-PAF) are still evolving and so far, considered to have disappointing rates of complete healing. We aimed to study the impact of multidisciplinary multimodality treatment approach in CD-PAF on the recurrence rates of fistula and need for re-interventions. Method This was a multinational multicentre retrospective cohort study with data collected in CD patients who developed fistula from 2010 to 2015. Multidisciplinary multimodality approach was defined as using a combination of medical treatments (antibiotics, immunomodulators, and biologics) along with surgical approach (examination under anaesthesia (EUA) +/- Seton drainage) at diagnosis. Results 253 adult onset CD-PAF patients were included. There was significant difference in fistula healing rates between simple and complex fistulae (complete healing 60% vs 41%, p=0.015). 52% of patients who received multimodality treatment had complete fistula healing. 27% of simple fistula and 40.3% of the complex patients had recurrent fistula needing re-intervention at a median of 12 months (range 1–36 months) from diagnosis of fistula. 22% of those with complete healing needed repeat surgery compared to 49% with partial healing and 71% in those with no healing (p= Conclusion In this multicentre cohort study, complete fistula healing rates were higher and the recurrence rates lower than previously reported. Presence of proctitis and lack of multidisciplinary approach are predictors for recurrence and re-intervention for CD-PAF. Disclosure of Interest None Declared

The objective of the present paper was to acquire information about the mastoidectomy size necessary to obtain an optimal placement of the direct acoustic cochlear implant actuator and fixation system. Ten human cadaveric temporal bones were dissected and implanted with direct acoustic cochlear implant. Mastoidectomy size was determined after implantation in each temporal bone. A bone bed for the receiver/stimulator, mastoidectomy and a large posterior tympanotomy were drilled out. The mastoidectomy was progressively enlarged posteriorly in small steps until the actuator template was judged adequately oriented to enable passage of the rod through the posterior tympanotomy without any contact with the bony walls. The distance between different landmarks in the mastoidectomy was measured. All measured values showed a high degree of consistency, with limited median absolute deviation values. One of the most critical measure, i.e. the distance between the posterior margin of the mastoidectomy to the superior rim of the bony external ear canal wall, ranged from 13 to 16 mm with a median value of 15 mm. Prior knowledge of the ideal size of the mastoidectomy for direct acoustic cochlear implant facilitates the positioning of the fixation system and may save time during implant surgery.

Objective:To verify the hypothesis that intravenous frusemide reduces endolymphatic hydrops, as evaluated by three-dimensional fluid-attenuated inversion recovery magnetic resonance imaging following intratympanic gadolinium administration.Methods:The study comprised 12 patients (7 females and 5 males, aged 19–74 years) with Ménière's disease. Disease duration ranged from 0.5 to 8 years, with a frequency of 0.5 to 6 vertigo spells per month, as calculated in the last 6 months. Three-dimensional fluid-attenuated inversion recovery magnetic resonance imaging was performed 24 hours after intratympanic injection of gadobutrol diluted eight-fold. Frusemide 20 mg was given intravenously immediately after imaging. Magnetic resonance imaging was repeated after 1 hour, using the same parameters and sequence.Results:All patients showed enhancement defects, indicating endolymphatic hydrops of variable degrees. No modifications occurred at the second magnetic resonance imaging performed 1 hour after frusemide administration.Conclusion:There was no evidence of endolymphatic hydrops modification 1 hour after intravenously administered frusemide. Therefore, loop diuretics in Ménière's disease, which are today used on an empirical basis, must be reconsidered. Implications of these outcomes are discussed and related to the role of endolymphatic hydrops in the development of Ménière's disease.