Objective: We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI).Methods: This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP.Results: A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI−7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI−3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found.Conclusion: EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489).Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03830489.

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Background During COVID-19 pandemic, numerous initiatives have been established to reduce disease transmission but ensure care for patients with inflammatory bowel disease (IBD). Ambulatory clinic visits were replaced by the implementation of telehealth modalities in most of IBD units during the pandemic lockdown. However, the efficacy, efficiency, and patient′s acceptability of using telemedicine by telephone consultation has not been evaluated. Methods A prospective cohort study was performed in IBD patients who underwent telephone consultation during lockdown due to COVID-19 pandemic between 16th march and 13th April 2020. To assess the efficacy of this telephone consultation (COVID-visit), change in disease′s activity and treatment, non-scheduled visits, emergency consultation, hospital admission and non-elective surgery from COVID-visit to the next scheduled consultation (postCOVID-visit) were checked. To evaluate efficiency, the time period between COVID-visit and postCOVID-visit were compared with previous consultation (preCOVID-visit). Only patients with a confirmed diagnosis of IBD, regular follow-up in our IBD unit and with full available requested test results were included. A telephone survey was designed (5 questions) and conducted in all patients to rate satisfaction for using telemedicine. Results Out of a total of 274 patients, 220 patients (52.2% male; mean age 49±16 years; crohn′s disease n=126/ ulcerative colitis n=83/ indeterminate colitis n=11) were included. During the COVID-visit 41% patients were using biologic agents, 15% had active disease and 6.8% changed treatment (40% initiated corticosteroids; 30% started immunomodulators or biologic agents; 30% upgraded usual treatment). Only 1 patient consulted at the emergency department, 11 patients needed to rearrange the visit and none patient underwent surgery before the scheduled post-COVID visit. The interval to post- COVID visit compared to pre-COVID visit was reduced in 28.6%, remained equal in 33.6% and increased in 37.7% of patients. The satisfaction survey (n=185) revealed that 81.1% patients rated care as excellent, 94.6% perceived it was effective and solved doubts in 96.2% of patients. However, 44.4% of patients rather prefer on-site consultation for follow-up and only 52% considered that incorporating video would improve care. Conclusion Telemedicine care during the lockdown and despite been abruptly and rapidly implemented in IBD units, shows to be effective and efficient to care IBD patients. In addition, telephone consultation is well accepted by patients for short follow-up periods. Further follow-up studies should be carried out to determine the patient profile that will benefit most from this monitoring.

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Non-alcoholic fatty liver disease (NAFLD) is a progressive disease that ranges from simple steatosis to cirrhosis. Obstructive sleep apnea syndrome (OSAS) and chronic intermittent hypoxia (CIH), are implicated in the pathogenesis of NAFLD. However, the overlapping consequences of CIH on liver sinusoidal endothelial function over time in NAFLD are largely unknown. We explored endothelial dysfunction in a rat model of NAFLD with high fat diet exposed to CIH (12 hours/day, every 30 sec to FIO2 8-10%). The livers were isolated and perfused and the endothelial function was determined by testing the vasodilation of the liver circulation to increased concentrations of acetylcholine, and von Willebrand factor (vWF) and intercellular adhesion molecule 1 (ICAM-1) expression. Phosphorylated endothelial nitric oxide synthase (p-eNOS), cGMP and oxidative stress were assessed to determine nitric oxide bioavailability. Inflammation and fibrosis were evaluated by transaminases, myeloperoxidase activity, hydroxyproline and histological evaluation. Hypoxia inducible factors (HIF) were studied as a marker of hypoxia and after a second insult with acetaminophen. CIH exposure provoked typical systemic features of OSAS and provoked a decreased response in vasodilation to acetylcholine. This was associated with increased oxidative stress and reduced p-eNOS and cGMP. The microcirculation impairment due to CIH preceded significant hepatic inflammation and fibrotic changes, despite the presence of HIF expression. In conclusion, CIH exacerbates endothelial dysfunction in NAFLD rats associated with increased oxidative stress and reduced nitric oxide bioavailability. This occurs before inflammation and fibrosis establish. Our results suggest that with CIH, endothelial dysfunction should be considered an early target.

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Background Nonadherence to medications is common in patients with inflammatory bowel disease (IBD) and can result in disease complications, therapy escalation, and the need for corticosteroids. The aim of this study was to assess adherence to self-administered (subcutaneous) biologic medications prescribed for IBD and to identify risk factors for biologic nonadherence. Methods A retrospective cohort study was performed on IBD patients starting and receiving subcutaneous biologic therapies from January 2016 to July 2019. Medical records were retrospectively reviewed and demographic and IBD data were collected. A modified medication possession ratio (mMPR) was calculated for the first 12-month treatment and at the end of follow-up (global-42 months). Nonadherence was defined as mMPR of less than 90%. Multiple regression analysis was performed to assess risk factors associated with non-adherence therapy Results A total of 154 patients (84M/70F; mean age starting biologic treatment 36 ±14 years; Crohn’s disease n = 118/ ulcerative colitis n = 31/ indeterminate colitis n = 5) were included; 121 received Adalimumab (ADA) and 33 were on Ustekinumab (UST); 63% of patients were naive to anti-TNF and 16.9% had received >2 previous biological treatment. Mean time from IBD diagnosis to use of subcutaneous biological agent was 16 ± 10 months. Mean time of subcutaneous agents use was 17.6(SD11.0) and 17.08 (SD6.8)months for ADA and UST, respectively. Global nonadherence (n = 154) (≤90% mMPR) was 6.6% for all patients receiving subcutaneous treatment and 6.3% for ADA and 6.5% for UST. Nonadherence during first 12-month treatment (n = 98) was 6.1% for all patients and 2.7 % for ADA and 16% for UST, respectively. In the multivariate analysis, Ustekinumab use was independently associated with higher nonadherence only for first 12-months adherence (OR 6.7, 95% CI 1.1–39.5). Conclusion Self-administered biologic treatment showed adequate global adherence in our study. Using subcutaneous administration for biologic agents in IBD patients forces us to monitor and control their adherence to ensure the therapeutic benefit.

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