Infection Control Practices and Outcomes of Endoscopy Units in the Lombardy Region of Italy: A Survey From the Italian Society of Digestive Endoscopy During COVID-19 Spread.

GOALS: The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area. BACKGROUND: Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy. METHODS: A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak. RESULTS: In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P=0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found. CONCLUSIONS: Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.

Performance of a multicompounds nutraceutical formulation in patients with symptomatic uncomplicated diverticular disease.

BACKGROUND: Symptomatic uncomplicated diverticular disease (SUDD) is a recognized clinical condition characterized by abdominal pain and changes in bowel habits, attributed to diverticula but without macroscopic signs of diverticulitis. There is no consensus about the management of these patients. Enteroflegin®, an association of natural active ingredients, could be effective in the treatment of those patients. METHODS: We conducted a retrospective observational study to evaluate the performances of Enteroflegin® in patients with SUDD. Patients were treated with Enteroflegin® 2 cp/day for 10 days per month for 6 months. Primary endpoint was the clinical remission rate, defined as the absence of any symptoms; secondary endpoints were the impact of the treatment on reduction of symptoms, on fecal calprotectin (FC) expression, and the prevention of acute diverticulitis. RESULTS: Three hundred and fifty patients were retrospectively enrolled (183 males, median age 64 years, IQR 54-70). Enteroflegin® was effective in inducing remission in 9.34% and 17.64% of patients at 3 and 6 months respectively (P<0.001). Reduction of symptoms occurred in 92.3% and in 85.3% of patients at 3 and 6 months respectively (P<0.001), and symptoms' recurrence or worsening was recorded in only 1.71% of patients during the follow-up. FC expression dropped from 181.3 µg/g at baseline to 100.2 µg/g (P<0.001) and to 67.9 µg/g (P<0.001) at 3 and 6 months of follow-up respectively. No adverse event was recorded during the follow-up. Finally, acute diverticulitis occurred in just 2% of patients during the follow-up. CONCLUSIONS: Enteroflegin® seems to be an effective nutraceutical compound in obtaining remission and symptom relief in SUDD patients. Further randomized, placebo-controlled clinical trials are needed to confirm these preliminary data.

Prospective evaluation of ERCP performance in an Italian regional database study.

BACKGROUND: Prospective studies about endoscopic retrograde cholangio-pancreatography (ERCP) in a community setting are rare. AIM: To assess success and complication rates of routinely-performed ERCP in a regional setting, and the priority quality indicators for ERCP practice. METHODS: Prospective region wide observational study on consecutive patients undergoing ERCP during a 6-month period. A centralized online ERCP questionnaire was built and used for data storage. Primary quality indicators provided by the American Society of Gastrointestinal Endoscopy (ASGE) were considered. RESULTS: 38 endoscopists from 18 centers performed a total of 2388 ERCP. The most common indication for ERCP was choledocholitiasis (54.8%) followed by malignant jaundice (22.6%). Cannulation of the desired duct was obtained in 2293 cases (96%) and ERCP was successful in 2176 cases (91.1%). Success and ERCP difficulty were significantly related to the experience of the operator (p = 0.001 and p < 0.001, respectively). ERCP difficulty was also significantly related to volume centers (p < 0.01). The overall complication rate was 8.4%: post-ERCP pancreatitis (PEP) occurred in 4.1% of procedures, bleeding in 2.9%, infection in 0.8%, perforation in 0.4%. Mortality rate was 0.4%. All the ASGE priority quality indicators for ERCP were confirmed. CONCLUSIONS: The procedural questionnaire proved to be an important tool to assess and verify the quality of routinely-performed ERCP performance in a community setting.

Outcome of non-variceal acute upper gastrointestinal bleeding in relation to the time of endoscopy and the experience of the endoscopist: a two-year survey.

AIM: To prospectively assess the impact of time of endoscopy and endoscopist's experience on the outcome of non-variceal acute upper gastrointestinal (GI) bleeding patients in a large teaching hospital. METHODS: All patients admitted for non-variceal acute upper GI bleeding for over a 2-year period were potentially eligible for this study. They were managed by a team of seven endoscopists on 24-h call whose experience was categorized into two levels (high and low) according to the number of endoscopic hemostatic procedures undertaken before the study. Endoscopic treatment was standardized according to Forrest classification of lesions as well as the subsequent medical therapy. Time of endoscopy was subdivided into two time periods: routine (8 a.m.-5 p.m.) and on-call (5 p.m.-8 a.m.). For each category of experience and time periods rebleeding rate, transfusion requirement, need for surgery, length of hospital stay and mortality we compared. Multivariate analysis was used to discriminate the impact of different variables on the outcomes that were considered. RESULTS: Study population consisted of 272 patients (mean age 67.3 years) with endoscopic stigmata of hemorrhage. The patients were equally distributed among the endoscopists, whereas only 19% of procedures were done out of working hours. Rockall score and Forrest classification at admission did not differ between time periods and degree of experience. Univariate analysis showed that higher endoscopist's experience was associated with significant reduction in rebleeding rate (14% vs 37%), transfusion requirements (1.8+/-0.6 vs 3.0+/-1.7 units) as well as surgery (4% vs 10%), but not associated with the length of hospital stay nor mortality. By contrast, outcomes did not significantly differ between the two time periods of endoscopy. On multivariate analysis, endoscopist's experience was independently associated with rebleeding rate and transfusion requirements. Odds ratios for low experienced endoscopist were 4.47 for rebleeding and 6.90 for need of transfusion after the endoscopy. CONCLUSION: Endoscopist's experience is an important independent prognostic factor for non-variceal acute upper GI bleeding. Urgent endoscopy should be undertaken preferentially by a skilled endoscopist as less expert staff tends to underestimate some risk lesions with a negative influence on hemostasis.

2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation.

BACKGROUND: Chronic constipation is a risk factor of inadequate bowel preparation for colonoscopy; however, no large clinical trials have been performed in this subgroup of patients. AIMS: To compare bowel cleansing efficacy, tolerability and acceptability of 2-L polyethylene-glycol-citrate-simethicone (PEG-CS) plus 2-day bisacodyl (reinforced regimen) vs. 4-L PEG in patients with chronic constipation undergoing colonoscopy. METHODS: Randomized, observer-blind, parallel group study. Adult outpatients undergoing colonoscopy were randomly allocated to 2-L PEG-CS/bisacodyl or 4-L PEG, taken as split regimens before colonoscopy. Quality of bowel preparation was assessed by the Ottawa Bowel Cleansing Scale (OBCS). The amount of foam/bubble interfering with colonic visualization was also measured. RESULTS: 400 patients were enrolled. There was no significant difference in successful cleansing (OBCS score ≤6): 80.2% in the 2-L PEG-CS/bisacodyl vs. 81.4% in the 4-L PEG group. Significantly more patients taking 2L PEG-CS/bisacodyl showed no or minimal foam/bubbles in all colonic segments (80% vs. 63%; p<0.001). 2-L PEG-CS/bisacodyl was significantly more acceptable for ease of administration (p<0.001), willingness to repeat (p<0.001) and showed better compliance (p=0.002). CONCLUSION: Split 2-L PEG-CS plus bisacodyl was not superior to split 4-L PEG for colonoscopy bowel cleansing in patients with chronic constipation; however, it performed better than the standard regimen in terms of colonic mucosa visualization, patient acceptance and compliance.

Incidence and risk factors for gallstones in patients with inflammatory bowel disease: a large case-control study.

UNLABELLED: The risk for gallstones (GD) in inflammatory bowel diseases and the factors responsible for this complication have not been well established. We studied the incidence of GD in a cohort of Crohn's disease (CD) and ulcerative colitis (UC) patients and investigated the related risk factors. A case-controlled study was carried out. The study population included 634 inflammatory bowel disease (IBD) patients (429 CD, 205 UC) and 634 age-matched, sex-matched, and body mass index (BMI)-matched controls free of GD at enrollment, who were followed for a mean of 7.2 years (range, 5-11 years). The incidence of GD was calculated by dividing the number of events per person-years of follow-up. Multivariate analysis was used to discriminate among the impact of different variables on the risk of developing GD. The incidence rates of GD were 14.35/1,000 persons/year in CD as compared with 7.75 in matched controls (P=0.012) and 7.48/1000 persons/year in UC patients as compared with 6.06 in matched-controls (P=0.38). Ileo-colonic CD location (OR, 2.14), disease duration>15 years (OR, 4.26), >3 clinical recurrences (OR, 8.07), ileal resection>30 cm (OR, 7.03), >3 hospitalizations (OR, 20.7), multiple TPN treatments (OR, 8.07), and long hospital stay (OR, 24.8) were significantly related to GD in CD patients. CONCLUSION: Only CD patients have a significantly higher risk of developing GD than well-matched hospital controls. Site of disease at diagnosis, lifetime surgery, extent of ileal resections, number of clinical recurrences, TPN, and the frequency and duration of hospitalizations are independently associated with GD.

Sonographic prevalence of liver steatosis and biliary tract stones in patients with inflammatory bowel disease: study of 511 subjects at a single center.

GOALS: Inflammatory bowel diseases (IBDs) are associated with pathologic findings in the liver and biliary tract. Ultrasonography (US) represents a noninvasive means to study hepatobiliary abnormalities. This study evaluated the prevalence of US hepatobiliary changes and their relationship to clinical variables in a large IBD patient population followed in a single center. STUDY: Five hundred eighty-three consecutive IBD patients were studied with US. After excluding patients with preexisting acute or chronic hepatitis, metabolic disorders, or obesity, 511 patients were investigated for age, duration, site, and severity of the disease, history of surgery, and present medical treatment. At US, liver size, echogenicity (graded as mild-to-moderate or severe indicating a corresponding degree of hepatic steatosis), focal lesions of the liver and gallbladder, and biliary tract abnormalities were recorded. RESULTS: Three hundred eleven patients with Crohn disease (CD) and 200 patients with ulcerative colitis (UC) were recruited for the study. Hepatobiliary abnormalities were found at US in 54.2% and 55.9% of CD and UC patients, respectively. Liver enlargement and mild-to-moderate to severe liver steatosis were found in 25.7% and 39.5% of CD patients and in 25.5% and 35.5% of UC patients, respectively, a higher prevalence than among healthy controls (P < 0.001). The prevalence of gallstones among CD patients was 11%, higher than that among UC patients (7.5%) and controls (5.5%) (P = 0.016). The higher risk of gallbladder stones in CD was related to age, female sex, and previous surgery. CONCLUSION: The prevalence of liver enlargement and liver steatosis was higher among IBD patients. The prevalence of gallstones was increased in CD patients only. This risk was related to age, female sex, and previous surgery.