A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study.

BACKGROUND: The importance of high quality preprocedural bowel preparation is widely acknowledged, but suboptimal bowel cleansing still occurs in up to 20 % of all colonoscopy patients. The aim of this study was to evaluate the performance of a novel intraprocedural cleaning device for cleaning poorly prepared colons. METHODS: This multicenter feasibility study included patients aged 18 - 75 years who were referred for colonoscopy. Intraprocedural cleaning was performed in patients after a limited preprocedural bowel preparation regimen (2 days of dietary restrictions and 2 × 10 mg bisacodyl). The primary outcome was the proportion of adequately prepared patients (Boston Bowel Preparation scale [BBPS] ≥ 2 in each segment) before and after segmental washing with the new device. Secondary outcomes included: cecal intubation rate, procedure time, system usability, patient satisfaction, and safety. RESULTS: 47 patients (42.6 % male), with a median age of 61 years (interquartile range [IQR] 46 - 67 years), were included at three clinical sites. Cecal intubation was achieved in 46/47 patients (97.9 %). The cleaning device significantly improved the proportion of patients with adequate bowel cleansing (from 19.1 % to 97.9 %; P < 0.001) and median BBPS score (from 3.0 [IQR 0.0 - 5.0] to 9.0 [IQR 8.0 - 9.0]). Median cecal intubation time and total procedure time were 16.5 minutes (IQR 9.0-28.3) and 34.0 minutes (IQR 25.0 - 42.8), respectively. Physicians were satisfied with the ease of use of the device and it was well tolerated by patients. No severe adverse events occurred during the study period. CONCLUSIONS: This feasibility study suggests that the intraprocedural cleaning device appears to be safe and effective in cleaning poorly prepared colons to an adequate level, allowing a thorough colorectal examination.

Early virological response may predict treatment response in sofosbuvir-based combination therapy of chronic hepatitis c in a multi-center "real-life" cohort.

BACKGROUND: The combination of sofosbuvir (SOF), ribavirin (RBV) and peg-interferon-alfa-2a (peg-IFN-alfa-2a) as well as the combination of SOF and RBV for the treatment of patients infected with hepatitis c virus (HCV) has improved rates of sustained virological response (SVR) considerably in recent trials. However, there is only limited data concerning the efficacy and safety in a "real-life" cohort. METHODS: We analyzed a cohort of 119 patients with chronic HCV infection treated at four investigational sites in Germany. All patients received either a combination treatment of SOF, RBV and peg-IFN-alfa-2a or SOF and RBV. RESULTS: The rates of SVR at 12 weeks after end of treatment (SVR 12) were as follows: Among 76 patients with genotype 1 infection the SVR 12 rate was 74% (n = 56), among 14 patients with genotype 2 infection the SVR 12 rate was 79% (n = 11), among 24 patients with genotype 3 infection the SVR 12 rate was 92% (n = 22) and among 5 patients with genotype 4 infection the SVR 12 rate was 80% (n = 4). Of all 26 patients with a relapse in our cohort, 69% (n = 18) of these patients presented with liver cirrhosis and 58% (n = 15) were treatment experienced. Notably, the level of HCV-RNA after 4 weeks of treatment was a significant predictor of treatment response in genotype 1 patients. Patients with HCV-RNA levels ≥ 12 IU ml-1 after 4 weeks of treatment achieved SVR 12 only in 30% (n = 17/56, p < 0.0001) of cases and treatment response was even lower with SVR 12 of 25% (n = 5/20, p = 0.0016) in the subgroup of patients with cirrhosis. CONCLUSION: We observed a high rate of SVR 12 with SOF-based treatment regimes, however probably due to the high number of patients with liver cirrhosis and prior treatment experience, treatment response rates were lower than in previously published trials. In genotype 1 patients the analysis of early virological response may predict treatment response in SOF-based combination therapies.

Medical appointments and provision of medical care during the COVID-19 pandemic in Mainz, Germany.

Previous evidence suggested that non-COVID-19-related medical care was reduced during the first wave of the COVID-19 pandemic, but it remained unclear whether or to which extent this effect lasted beyond the first wave, or existed in a longer time frame. Here, we consider questionnaire data of the Gutenberg-COVID-19 study together with pre-pandemic baseline data of the Gutenberg Health Study concerning the region around Mainz, Germany, to study the effects of the pandemic on the provision of medical care until April 2021. We observed that the proportion of cancelled medical appointments was low and that the fraction of participants with a medical appointment as an indicator for the number of appointments being made was in line with pre-pandemic levels. Appointments were more likely cancelled by the patient (rather than the provider), and more likely cancelled by medical specialists such as dentists or ophthalmologists (rather than GPs). In conclusion, we found some evidence that, at least with regard to realized appointments, the medical system and the provision of medical care were not harmed by the COVID-19 pandemic on a longer time scale.

Adding pegylated interferon to a current nucleos(t)ide therapy leads to HBsAg seroconversion in a subgroup of patients with chronic hepatitis B.

BACKGROUND: Nucleos(t)ides effectively halt disease progression in hepatitis B but require long-term medication. OBJECTIVES: To determine whether add-on of peg-IFN to an ongoing nucleos(t)ide therapy accelerates decline of HBsAg and induces seroconversion. STUDY DESIGN: We observed HBsAg kinetics in 12 patients on a stable oral therapy with undetectable HBV-DNA who additionally received peg-IFN-alfa 2a as an individualized therapy. 3 patients were HBeAg positive. Mean baseline HBsAg was 4695 (range 16-15,120)IU/ml. RESULTS: A continuous decline of HBsAg was observed in 2 patients. The slope, respectively, became detectable at week 8 or 16. HBsAg had dropped by 2.90log(10) or 4.25log(10) fold at week 48, and anti-HBs appeared at week 40 or 32. Patient A - HBe-positive, genotype A, F3 fibrosis - had been HBV-DNA negative for 10 months receiving entecavir plus tenofovir. Previous therapy with peg-IFN had been unsuccessful, but now the patient experienced HBeAg seroconversion at week 24. Patient B - HBeAg negative, genotype D, cirrhosis - had a low initial HBsAg level of 16U/l. Receiving entecavir, his HBV-DNA had previously been non-detectable for 27 months. In the remaining 10 patients HBsAg declined only by a mean of 0.09log(10) (range 0.01-0.25log(10)) after 8-24 (mean 16.4) weeks, and therefore, peg-IFN was stopped. No unexpected side effects were observed. DISCUSSION: We observed that the add-on of peg-IFN induced HBsAg seroconversion in 2 out of 12 patients. Response rates may have been higher with prolongation of therapy. The add-on concept merits to be evaluated in a clinical trial.