Diverticular Inflammation and Complication Assessment classification, CODA score and fecal calprotectin in clinical assessment of patients with diverticular disease: A decision curve analysis.

BACKGROUND AND AIMS: The Diverticular Inflammation and Complication Assessment (DICA) classification and the Combined Overview on Diverticular Assessment (CODA) were found to be effective in predicting the outcomes of Diverticular Disease (DD). We ascertain whether fecal calprotectin (FC) can further aid in improving risk stratification. METHODS: A three-year international, multicentre, prospective cohort study was conducted involving 43 Gastroenterology and Endoscopy centres. Survival methods for censored observations were used to estimate the risk of acute diverticulitis (AD) in newly diagnosed DD patients according to basal FC, DICA, and CODA. The net benefit of management strategies based on DICA, CODA and FC in addition to CODA was assessed with decision curve analysis, which incorporates the harms and benefits of using a prognostic model for clinical decisions. RESULTS: At the first diagnosis of diverticulosis/DD, 871 participants underwent FC measurement. FC was associated with the risk of AD at 3 years (HR per each base 10 logarithm increase: 3.29; 95% confidence interval, 2.13-5.10) and showed moderate discrimination (c-statistic: 0.685; 0.614-0.756). DICA and CODA were more accurate predictors of AD than FC. However, FC showed high discrimination capacity to predict AD at 3 months, which was not maintained at longer follow-up times. The decision curve analysis comparing the combination of FC and CODA with CODA alone did not clearly indicate a larger net benefit of one strategy over the other. CONCLUSIONS: FC measurement could be used as a complementary tool to assess the immediate risk of AD. In all other cases, treatment strategies based on the CODA score alone should be recommended.

Prevalence and Natural History of Segmental Colitis Associated With Diverticulosis.

INTRODUCTION: We assessed the prevalence and clinical outcomes of segmental colitis associated with diverticulosis (SCAD) in patients with newly diagnosed diverticulosis. METHODS: A 3-year international, multicenter, prospective cohort study was conducted involving 2,215 patients. RESULTS: SCAD diagnosis was posed in 44 patients (30 male patients; median age: 64.5 years; prevalence of 1.99%, 95% confidence interval, 1.45%-2.66%). Patients with SCAD types D and B showed worse symptoms, higher fecal calprotectin values, needed more steroids, and reached less likely complete remission. DISCUSSION: Although SCAD generally had a benign outcome, types B and D were associated with more severe symptoms and worse clinical course.

Efficacy of vedolizumab as maintenance therapy in a patient with ulcerative colitis receiving haemodialysis in end-stage kidney failure: A case report.

This report describes vedolizumab's clinical efficacy and safety in a patient with severe ulcerative colitis on haemodialysis for an end-stage kidney failure. The patient was a 75-year-old man on long-standing chronic diffusive three times per week haemodialytic treatment due to vascular nephropathy. At the presentation, the patient had severe bloody diarrhoea treated with a steroid cycle with temporary benefits and then developed steroid dependence. Upon remission, the patient started vedolizumab (Entivyo®) as maintenance therapy. After 6 weeks of induction, patient started the maintenance therapy with an infusion every 8 weeks. After the sixth infusion, the interval was prolonged to 9 weeks because of the good and fast response. Vedolizumab treatment proceeded without adverse events. However, no changes in renal function were noted during the same period, no complications were reported, and the patient regularly continued haemodialysis. At the second induction infusion (week 2) and the second maintenance infusion (week 22), we measured vedolizumab serum level before and after haemodialysis, observing no significant changes. Our case is the first report about using vedolizumab in a patient under haemodialysis, showing that vedolizumab can be safe, well tolerated, and effective in patients undergoing haemodialysis. However, more extensive trials are needed to prove its use in these patients.

Risk factors for inadequate bowel preparation in patients using high- and low-volume cleansing products.

INTRODUCTION: Bowel preparation is crucial for colonoscopy completeness and lesions detection. Today, several cleansing products are equally recommended by guidelines, irrespective of patients' characteristics. Identification of preparation-specific risk factors for inadequate bowel preparation may lead to a personalized prescription of cleansing products to refine patients' tolerance and improve endoscopic outcomes. METHODS: We prospectively enrolled consecutive outpatients referred for colonoscopy using either a high-volume [HV: 4 l polyethylene glycol (PEG)] or a low-volume (LV: 2 l PEG + bisacodyl) preparation. Day-before regimen or split-dose regimen was used for morning or afternoon colonoscopies, respectively. Univariate and multivariate analyses were conducted to identify risk factors related to inadequate bowel preparation, according to the Boston bowel preparation scale for HV and LV preparations. RESULTS: We enrolled 2040 patients, of which 1815 were included in the final analysis (average age 60.6 years, 50.2% men). Half of them (52%) used LV preparation. Adequate preparation was achieved by 87.6% without differences between the HV and LV groups (89.2% vs. 86.6%; P = 0.098). The use of day-before regimen and incomplete assumption of PEG were independent predictors of poor visibility for either HV or LV preparation. However, different specific risk factors for HV [diabetes: odds ratio (OR), 3.81; 95% confidence interval (CI), 1.91-7.58; low level of instruction: OR, 1.95; 95% CI, 1.11-3.44; and previous abdominal surgery: OR, 2.27; 95% CI, 1.20-4.30] and for LV (heart disease: OR, 2.06; 95% CI, 1.09-3.88; age > 65 years: OR, 1.51; 95% CI, 1.01-2.27) preparations were identified. CONCLUSION: Day-before preparation and incomplete assumption of the purgative agents affect bowel visibility irrespective of the preparation volume. LV should be preferred to HV preparations in patients with diabetes, low level of instruction, and previous abdominal surgery, whereas an HV preparation should be preferred in patients with heart disease and in older patients.

Prognostic performance of the 'DICA' endoscopic classification and the 'CODA' score in predicting clinical outcomes of diverticular disease: an international, multicentre, prospective cohort study.

OBJECTIVE: To investigate the predictive value of the Diverticular Inflammation and Complication Assessment (DICA) classification and to develop and validate a combined endoscopic-clinical score predicting clinical outcomes of diverticulosis, named Combined Overview on Diverticular Assessment (CODA). DESIGN: A multicentre, prospective, international cohort study. SETTING: 43 gastroenterology and endoscopy centres located in Europe and South America. PARTICIPANTS: 2215 patients (2198 completing the study) at the first diagnosis of diverticulosis/diverticular disease were enrolled. Patients were scored according to DICA classifications. INTERVENTIONS: A 3-year follow-up was performed. MAIN OUTCOME MEASURES: To predict the acute diverticulitis and the surgery according to DICA classification. Survival methods for censored observation were used to develop and validate a novel combined endoscopic-clinical score for predicting diverticulitis and surgery (CODA score). RESULTS: The 3-year cumulative probability of diverticulitis and surgery was of 3.3% (95% CI 2.5% to 4.5%) in DICA 1, 11.6% (95% CI 9.2% to 14.5%) in DICA 2 and 22.0% (95% CI 17.2% to 28.0%) in DICA 3 (p<0.001), and 0.15% (95% CI 0.04% to 0.59%) in DICA 1, 3.0% (95% CI 1.9% to 4.7%) in DICA 2 and 11.0% (95% CI 7.5% to 16.0%) in DICA 3 (p<0.001), respectively. The 3-year cumulative probability of diverticulitis and surgery was ≤4%, and ≤0.7% in CODA A; <10% and <2.5% in CODA B; >10% and >2.5% in CODA C, respectively. The CODA score showed optimal discrimination capacity in predicting the risk of surgery in the development (c-statistic: 0.829; 95% CI 0.811 to 0.846) and validation cohort (c-statistic: 0.943; 95% CI 0.905 to 0.981). CONCLUSIONS: DICA classification has a significant role in predicting the risk of diverticulitis and surgery in patients with diverticulosis, which is significantly enhanced by the CODA score. TRIAL REGISTRATION NUMBER: NCT02758860.

Efficacy and tolerability of high and low-volume bowel preparation compared: A real-life single-blinded large-population study.

BACKGROUND: Low-volume preparations for colonoscopy have shown similar efficacy compared to high-volume ones in randomized controlled trials (RCT). However, most RCTs do not provide data about clinical outcomes including lesions detection rate. Moreover, real-life comparisons are lacking. AIM: To compare efficacy (both in terms of adequate bowel preparation and detection of colorectal lesions) and tolerability of a high-volume (HV: 4 L polyethylene glycol, PEG) and a low-volume (LV: 2 L PEG plus bisacodyl) bowel preparation in a real-life setting. METHODS: Consecutive outpatients referred for colonoscopy were prospectively enrolled between 1 December 2014 and 31 December 2016. Patients could choose either LV or HV preparation, with a day-before schedule for morning colonoscopies and a split-dose for afternoon procedures. Adequate bowel preparation according to Boston Bowel Preparation Scale (BBPS), clinical outcomes including polyp detection rate (PDR), adenoma detection rate (ADR), advanced adenoma detection rate (AADR), sessile/serrated lesion detection rate (SDR) and cancer detection rate and self-reported tolerability of HV and LV were blindly assessed. RESULTS: Total 2040 patients were enrolled and 1815 (mean age 60.6 years, 50.2% men) finally included. LV was chosen by 52% of patients (50.8% of men, 54.9% of women). Split-dose schedule was more common with HV (44.7% vs 38.2%, P = 0.005). High-definition scopes were used in 33.4% of patients, without difference in the two groups (P = 0.605). HV and LV preparations showed similar adequate bowel preparation rates (89.2% vs 86.6%, P = 0.098), also considering the two different schedules (HV split-dose 93.8% vs LV split-dose 93.6%, P = 1; HV day-before 85.5% vs LV day-before 82.3%, P = 0.182). Mean global BBPS score was higher for HV preparations (7.1 ± 1.7 vs 6.8 ± 1.6, P < 0.001). After adjustment for sex, age and indications for colonoscopy, HV preparation resulted higher in PDR [Odds ratio (OR) 1.32, 95%CI: 1.07-1.63, P = 0.011] and ADR (OR 1.29, 95%CI 1.02-1.63, P = 0.038) and comparable to LV in AADR (OR 1.51, 95%CI 0.97-2.35, P = 0.069), SDR and cancer detection rate. The use of standard-definition colonoscopes was associated to lower PDR (adjusted OR 1.59, 95%CI: 1.22-2.08, P < 0.001), ADR (adjusted OR 1.71, 95%CI: 1.26-2.30, P < 0.001) and AADR (adjusted OR 1.97, 95%CI: 1.09-3.56, P = 0.025) in patients receiving LV preparation. Mean Visual Analogue Scale tolerability scored equally (7, P = 0.627) but a ≥ 75% dose intake was more frequent with LV (94.6% vs 92.1%, P = 0.003). CONCLUSION: In a real-life setting, PEG-based low-volume preparation with bisacodyl showed similar efficacy and tolerability compared to standard HV preparation. However, with higher PDR and ADR, HV should still be considered as the reference standard for clinical trials and the preferred option in screening colonoscopy, especially when colonoscopy is performed with standard resolution imaging.

Computerised analysis of antepartum foetal heart parameters: New reference ranges.

We selected 4012 cCTG records (one trace for each patient) performed in healthy pregnancies from 30th to 42nd gestational week using foetal heart rate (FHR), short-term variability (STV), long-term irregularity (LTI), Delta, approximate entropy (ApEn), spectral components as low frequency (LF), median frequency (MF), high frequency (HF) and LF/(HF + MF) ratio were analysed. Reference nomograms were created and sensitivity and specificity for the prediction of foetal compromise were calculated which were 90% and 89%, respectively. Changes of cCTG parameters according to gestational week were evaluated: FHR (r = -.65) and LF (r = -.87) showed a statistically significant reduction (p < .05) with gestational age. STV (r = .59), LTI (r = .69), Delta (r = .67), and MF (r = .88) showed a statistically significant increase (p < .05) with gestational age. In contrast, for ApEn (r = -.098), HF (r = .14) and LF/(HF + MF) ratio (r = -.47) a non-statistically significant change was found (p > .05). The identification of reference ranges for cCTG indexes in according to gestational age could provide a more objective examination of cCTG trace.

Computerized analysis of fetal heart rate variability signal during the stages of labor.

AIM: To analyze computerized cardiotocographic (cCTG) parameters (baseline fetal heart rate, baseline FHR; short term variability, STV; approximate entropy, ApEn; low frequency, LF; movement frequency, MF; high frequency, HF) in physiological pregnancy in order to correlate them with the stages of labor. This could provide more information for understanding the mechanisms of nervous system control of FHR during labor progression. METHODS: A total of 534 pregnant women were monitored on cCTG from the 37th week before the onset of spontaneous labor and during the first and the second stage of labor. Statistical analysis was performed using Kruskal-Wallis test and Wilcoxon rank-sum test with the Bonferroni adjusted α (< 0.05). RESULTS: Statistically significant differences were seen between baseline FHR, MF and HF (P < 0.001), in which the first two were reduced and the third was increased when compared between pre-labor, and the first and second stages of labor. Differences between some of the stages were found for ApEn, LF and for LF/(HF + MF), where the first and the third were reduced and the second was increased. CONCLUSIONS: cCTG modifications during labor may reflect the physiologic increased activation of the autonomous nervous system. Using computerized fetal heart rate analysis during labor it may be possible to obtain more information from the fetal cardiac signal, in comparison with the traditional tracing.

Development and validation of an endoscopic classification of diverticular disease of the colon: the DICA classification.

BACKGROUND: A validated endoscopic classification of diverticular disease (DD) of the colon is lacking at present. Our aim was to develop a simple endoscopic score of DD: the Diverticular Inflammation and Complication Assessment (DICA) score. METHODS: The DICA score for DD resulted in the sum of the scores for the extension of diverticulosis, the number of diverticula per region, the presence and type of inflammation, and the presence and type of complications: DICA 1 (≤ 3), DICA 2 (4-7) and DICA 3 (>7). A comparison with abdominal pain and inflammatory marker expression was also performed. A total of 50 videos of DD patients were reassessed in order to investigate the predictive role of DICA on the outcome of the disease. RESULTS: Overall agreement in using DICA was 0.847 (95% confidence interval, CI, 0.812-0.893): 0.878 (95% CI 0.832-0.895) for DICA 1, 0.765 (95% CI 0.735-0.786) for DICA 2 and 0.891 (95% CI 0.845-0.7923) for DICA 3. Intra-observer agreement (kappa) was 0.91 (95% CI 0.886-0.947). A significant correlation was found between the DICA score and C-reactive protein values (p = 0.0001), as well as between the median pain score and the DICA score (p = 0.0001). With respect to the 50 patients retrospectively reassessed, occurrence/recurrence of disease complications was recorded in 29 patients (58%): 10 (34.5%) were classified as DICA 1 and 19 (65.5%) as DICA 2 (p = 0.036). CONCLUSIONS: The DICA score is a simple, reproducible, validated and easy-to-use endoscopic scoring system for DD of the colon.

Governance of innovation and appropriateness of hospitalization for high-risk pregnancy: the TOCOMAT system.

BACKGROUND: Over the last 30 years, a great increase in the application of technologies in public health, with an undisputed impact on both the effectiveness of performance and the investment and management costs, has occurred. This evidence has induced the development of assessment tools to clarify the relationships among resources, outputs, and outcomes of technological innovations. This analysis was developed in order to examine the use of a telematic system for reporting remotely transmitted cardiotocographic traces, specifically (1) its impact on the health organization and on the appropriateness of the care setting used and (2) the efficiency of its adoption in a regional network. MATERIALS AND METHODS: We adopted a case-control study on patients' medical records during the first 4 months of 2009, 2010, and 2011 and a cost analysis of resources used for the creation of a computerized telecardiotocography network connecting eight peripheral areas to the operations center. RESULTS: The case-control study showed a reduction in the average hospital stay days for high-risk patients (1.32) and for low-risk patient (1.7) with a total of cost savings of €89,628 for high-risk patients and €170,170 for low-risk patients. The cost savings of the regional network was €20,769.04. CONCLUSIONS: The adoption of a remote transmission system of cardiotocography provided a managerial and economic advantage in the reduction of inappropriate admissions for prepartum symptoms and an improvement in the admission indicators (hospital stay days).

Upper gastrointestinal involvement of Crohn's disease: a prospective study on the role of upper endoscopy in the diagnostic work-up.

BACKGROUND: Prevalence of upper gastrointestinal (GI) tract involvement in adult Crohn's disease (CD) has been reported to be very low (0.3-5%). In routine practice, upper endoscopy is recommended only in CD patients with upper GI symptoms. Available data concerning the prevalence of asymptomatic upper GI lesions in CD patients are controversial. The aim of this study was to prospectively evaluate the prevalence of upper GI CD involvement in CD patients, irrespective of upper GI symptoms. METHODS: A series of 119 consecutive CD patients underwent clinical assessment, including occurrence and score of upper GI symptoms, and upper endoscopy with biopsy samples for histological assessment and Helicobacter pylori (Hp) infection detection. In an attempt to further recognize the upper GI tract lesions as CD or other form of inflammation, in a subgroup of CD patients, the histological and endoscopic evaluation was repeated following 12 weeks of anti-TNF-α or other treatments in association with proton-pump inhibitors. RESULTS: Upper CD involvement was found in 19/119 (16%) patients. Hp infection was detected in 10/119 (8.4%) CD patients. Hp-negative focally active chronic gastritis was found in 34/119 (28.6%) CD patients. At presentation, 12/19 patients (63%) showing upper CD involvement were asymptomatic and 7 (37%) symptomatic. CONCLUSION: A high prevalence of upper GI tract involvement has been observed in CD patients, irrespective of upper symptoms. This finding suggests the usefulness of routine upper endoscopy in the diagnostic work-up of CD patients in order to correctly classify the distribution and extent of the disease.

Pelvic adhesion and gonadotropin-releasing hormone analogue: effects of triptorelin acetate depot on coagulation and fibrinolytic activities.

The study investigated the impact of gonadotropin-releasing hormone analogue (GnRH-a) on coagulation and fibrinolytic activities and its effectiveness in the prevention of pelvic adhesion after myomectomy. Thirty-two infertile women underwent myomectomy followed by adhesion evaluation surgery with a second-look laparoscopy. Before myomectomy, 15 women were treated with triptorelin acetate for 3 months and 17 received no treatment. Plasminogen activator inhibitor (PAI), thrombin activatable fibrinolysis inhibitor (TAFI), protein C (PC), plasminogen, α2-antiplasmin were determined by enzyme-linked immunosorbent assays and the activity of coagulation factors V and VIII by coagulometric methods. Patients treated with GnRH-a showed significant decrease in PAI, TAFI, factors V, and VIII (P < .05) and increased PC (P < .05), but no significant change in plasminogen and α2-antiplasmin levels compared with control group. The incidence, extent, and severity of adhesions were significantly lower in GnRH-a-treated patients compared with control group (P < .05), suggesting a possible critical role of the GnRH-a therapy in preventing postoperative adhesion development.

Fetal vibroacoustic stimulation in computerized cardiotocographic analysis: the role of short-term variability and approximate entropy.

The aim of this study was to evaluate the impact of vibroacoustic stimulation (VAS) on computerized cardiotocography short-term variability (STV) and approximate entropy (ApEn) in both low- and high-risk pregnancies. VAS was performed on 121 high- and 95 low-risk pregnancies after 10 minutes of continuous quiet, while their FHR parameters were monitored and recorded by cCTG analysis. Fetal heart rate was recorded using a computer-assisted equipment. Baseline FHR, accelerations, decelerations, STV, long-term irregularity (LTI), ApEn, and fetal movements (FMs) were calculated for defined observational periods before VAS and after 10 minutes. Data were also investigated in relationship with the perinatal outcome. In each group of patients, FHR after VAS remained almost unmodified. Fetal movements significantly increased after VAS in both groups. Results show that only in the high-risk pregnancies, the increase of STV and the decrease of ApEn after VAS were significantly associated with favorable perinatal outcomes.

Severe acute hypertriglyceridemia during acute lymphoblastic leukemia induction successfully treated with plasmapheresis.

Children suffering from Acute Lymphoblastic Leukaemia (ALL) treated with asparaginase and corticosteroids are at risk of developing severe lipid abnormalities. The authors report the case of a 10-year-old male with extremely high plasma triglyceride concentrations (4,000 mg/dl) during the induction phase of ALL associated with mild pancreatitis. Hypertriglyceridemia was successfully managed with plasmapheresis with a decrease in triglyceride levels to 590 mg/dl. Apheresis appears to be safe and effective in reducing hypertriglyceridemia and preventing related complications.

Maintenance of remission with infliximab in inflammatory bowel disease: efficacy and safety long-term follow-up.

AIM: To evaluate the safety and efficacy of a long-term therapy with infliximab in Crohn's disease (CD) and ulcerative colitis (UC) patients retrospectively. METHODS: The medical charts of 50 patients (40 CD and 10 UC), who received after a loading dose of 3 infliximab infusions scheduled re-treatments every 8 wk as a maintenance protocol, were reviewed. RESULTS: Median (range) duration of treatment was 27 (4-64) mo in CD patients and 24.5 (6-46) mo in UC patients. Overall, 32 (80%) CD and 9 (90%) UC patients showed a sustained clinical response or remission throughout the maintenance period. Three CD patients shortened the interval between infusions. Eight (20%) CD patients and 1 UC patient underwent surgery for flare up of disease. Nine out of 29 CD and 4 out of 9 UC patients, who discontinued infliximab scheduled treatment, are still relapse-free after a median of 16 (5-30) and 6.5 (4-16) mo following the last infusion, respectively. Ten CD patients (25%) and 1 UC patient required concomitant steroid therapy during maintenance period, compared to 30 (75%) and 9 (90%) patients at enrollment. Of the 50 patients, 16 (32%) experienced at least 1 adverse event and 3 patients (6%) were diagnosed with cancer during maintenance treatment. CONCLUSION: Scheduled infliximab strategy is effective in maintaining long-term clinical remission both in CD and UC and determines a marked steroid sparing effect. Long-lasting remission was observed following infliximab withdrawal.