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Stock C.,German Cancer Research Center | Ihle P.,University of Cologne | Sieg A.,Practice of Gastroenterology | Schubert I.,University of Cologne | And 2 more authors.
Gastrointestinal Endoscopy | Year: 2013

Background: The incidence of adverse events (AEs) is a crucial factor when colonoscopy is considered for mass screening, but few studies have addressed delayed and non-GI AEs. Objectives: To investigate the risk of AEs requiring hospitalization after screening and nonscreening colonoscopies compared with control subjects who did not undergo colonoscopy. Design: Retrospective matched cohort. Setting: Statutory health insurance fund in Germany. Patients: A total of 33,086 individuals who underwent colonoscopy as an outpatient (8658 screening, 24,428 nonscreening) and 33,086 matched controls who did not undergo colonoscopy. Interventions: Outpatient screening and nonscreening colonoscopies. Main Outcomes Measurements: Risk of AEs (perforation, bleeding, myocardial infarction, stroke, splenic injury, and others) requiring hospitalization within 30 days after colonoscopy/index date and risk differences between the group that underwent colonoscopy and the group that did not. Results: The incidence of perforation was 0.8 (95% confidence interval [CI], 0.3-1.7) and 0.7 (95% CI, 0.4-1.1) per 1000 screening and nonscreening colonoscopies, respectively. Hospitalizations because of bleeding occurred in 0.5 (95% CI, 0.1-1.2) and 1.1 (95% CI, 0.8-1.7) per 1000 screening and nonscreening colonoscopies, respectively. The incidence of myocardial infarction, stroke, and other non-GI AEs was similar in colonoscopy and control groups. No splenic injury was observed. Those with AEs generally had a higher mean age and comorbidity rate than the overall study population. Limitations: The analysis relies on health insurance claims data. Conclusions: This study provides further evidence of the safety of colonoscopy in routine practice with regard to delayed and non-GI AEs. Hospitalizations because of the investigated AEs were uncommon or rare for both screening and nonscreening colonoscopies. © 2013 American Society for Gastrointestinal Endoscopy.


Hofmann W.P.,Practice of Gastroenterology | Mauss S.,Center for and Hepatogastroenterology | Lutz T.,Infektiologikum | Schober A.,Practice of Hepatology | And 7 more authors.
PLoS ONE | Year: 2015

Background and Aims: Individualization of treatment with peginterferon alfa and ribavirin in patients with chronic hepatitis C showed benefit in controlled trials and was implemented in treatment guidelines to increase response rates and to reduce side effects and costs. However, it is unknown whether individualization was adopted in routine daily practice and whether it translated into improved outcomes. Methods: From a large noninterventional cohort study, clinical and virologic response data of 10,262 HCV patients who received peginterferon alfa-2a and ribavirin between 2003-2007 and 2008-2011 were analyzed. To account for treatment individualization, a matched-pair analysis (2,997 matched pairs) was performed. Variation in treatment duration and dosing of ribavirin were analyzed as indicators for individualization. Results: Sustained virological response (SVR) rates were similar between 2003-2007 and 2008-2011 (62.0% vs. 63.7%). Patients with comorbidities were more abundant in the later period, (44.3% vs. 57.1%). The subsequent matched-pair analysis demonstrated higher SVR rates in the 2008-2011 period (64.3%) than in the 2003-2007 period (61.2%, p=0.008). More patients received abbreviated or extended treatment regimens in the later than the earlier period as an indicator of treatment individualization. To the same end, ribavirin doses were higher in the later period (12.6 versus 11.6 mg/kg/day). Factors independently associated with SVR included HCV genotype, low baseline viral load, younger age, route of infection, absence of concomitant diseases, lower APRI score, normal gamma-GT, higher ribavirin doses, no substitution for drug abuse, treatment duration, and treatment in the 2008-2011 period. Conclusions: Treatment individualization with peginterferon alfa and ribavirin was implemented in daily routine between 2003-2007 and 2008-2011, SVR rates improved in the same period. These findings may be most relevant in resource-limited settings. © 2015 Hofmann et al.


Sieg A.,Practice of Gastroenterology
Expert Review of Medical Devices | Year: 2011

Given the low compliance with screening colonoscopy in countries with a national colorectal cancer screening program, noninvasive methods with an acceptable high rate of sensitivity and specificity are welcome to enlarge the array of screening tools. Colon capsule endoscopy seems to be a safe and effective method of visualizing the colonic mucosa without the need for sedation or insufflation of air. Bowel cleansing for colon capsule endoscopy is more rigorous as only excellent or good results can be accepted in order to obtain an adequate sensitivity. This restricts its application on persons who are able to drink 4 l of polyethylene glycol plus laxatives. The sensitivity of colon capsule endoscopy to detect polyps, advanced adenomas and cancer is lower compared with optical colonoscopy. It still seems to be an adequate alternative for patients reluctant to undergo colonoscopy. Conventional colonoscopy is still established as the gold standard in colorectal cancer screening and is used to evaluate positive screening tests of all programs. It is the only method with the ability to remove detected polyps and obtain biopsy specimens. © 2011 Expert Reviews Ltd.

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