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Aschaffenburg, Germany

Halphen M.,Norgine Ltd | Kloess H.R.,Norgine GmbH | Fischbach W.,Klinikum Aschaffenburg
PLoS ONE | Year: 2015

Objectives: Efficacy of two low volume bowel cleansing preparations, polyethylene glycol plus ascorbate (PEG+Asc) and sodium picosulfate/magnesium citrate (NaPic/MgCit), were compared for polyp and adenoma detection rate (PDR and ADR) and overall cleansing ability. Primary endpoint was PDR (the number of patients with -1 polypoid or flat lesion recorded by the colonoscopist). Methods: Diagnostic, surveillance or screening colonoscopy patients were enrolled into this investigator-blinded, multi-center Phase IV study and randomized 1:1 to receive PEG+Asc (administered the evening before and the morning of colonoscopy, per label) or NaPic/MgCit (administered in the morning and afternoon the day before colonoscopy, per label). The blinded colonoscopist documented any lesion and assessed cleansing quality (Harefield Cleansing Scale). Results: Of 394 patients who completed the study, 393 (PEG+Asc, N=200; NaPic/MgCit, N=193) had a colonoscopy. Overall PDR for PEG+Asc versus NaPic/MgCit was 51.5%versus 44.0%, p=0.139. PDR and ADR on the right side of the bowel were significantly higher with PEG+Asc versus NaPic/MgCit (PDR: 56[28.0%] versus 32[16.6%], p=0.007; ADR: 42 [21.0%] versus 23[11.9%], p=0.015), as was detection of flat lesions (43[21.5%] versus 25 [13.0%], p=0.025). Cleansing quality was better with PEG+Asc than NaPic/MgCit (98.5% versus 57.5% considered successful cleansing). Overall, there were 132 treatment-emergent adverse events (93 versus 39 for PEG+Asc and NaPic/MgCit, respectively). These were mainly mild abdominal symptoms, all of which were reported for higher proportions of patients in the PEG+Asc than NaPic/MgCit group. Twice as many patients in the NaPic/MgCit versus the PEG+Asc group reported tolerance of cleansing solution as 'very good'. Conclusions: Compared with NaPic/MgCit, PEG+Asc may be more efficacious for overall cleansing ability, and subsequent detection of right-sided and flat lesions. This is likely attributable to the different administration schedules of the two bowel cleansing preparations, which may positively impact the detection and prevention of colorectal cancer, thereby improving mortality rates. Trial Registration: ClinicalTrials.gov NCT01689792. © 2015 Pohl et al. Source


Belsey J.,JB Medical Ltd | Crosta C.,Italian National Cancer Institute | Epstein O.,Center for Gastroenterology | Fischbach W.,Klinikum Aschaffenburg | And 3 more authors.
Current Medical Research and Opinion | Year: 2012

Objective: It is unclear whether small bowel visibility in video capsule endoscopy (VCE) is enhanced by the use of bowel preparation in addition to pre-procedural fasting. The objective of this study was to clarify this issue by means of a systematic review of the literature and meta-analysis. Methods: Randomised controlled trials comparing the use of laxative bowel preparation with fasting alone were identified using a literature search. Categorical measures of treatment efficacy were extracted from qualifying studies and pooled using random-effects meta-analyses. Primary analysis compared any bowel preparation with fasting alone; subsidiary analyses assessed diagnostic yield and results for each regimen. Results: Eight studies were identified, using either polyethylene glycol (PEG) or sodium phosphate (NaP) based regimens. No qualifying studies were identified using other laxatives. Study quality was sufficiently high to warrant meta-analysis. Use of any form of bowel preparation yielded significantly better visibility than fasting alone (OR=2.31; 95% CI=1.46-3.63; p<0.0001). Similar results were seen for diagnostic yield (OR=1.88; 95% CI=1.24-2.84; p=0.023). When sub-analysed according to the treatment used, PEG-based regimens showed benefit (OR=3.11; 95% CI=1.96-4.94; p<0.0001), while NaP-based regimens yielded no significant difference from fasting alone (OR=1.32; 95% CI=0.59-2.96; p<0.0001). Limitations: The study did not consider results from retrospective studies, nor those which did not give a categorical measure of efficacy. The impact of prokinetic and other adjunctive treatments was not considered. The results are only relevant to the most commonly used video capsule, as data for newer alternative devices have not yet been published. Conclusion: Based on the results of this analysis, the use of bowel preparation alongside fasting is recommended for VCE. PEG-based regimens offer a clear advantage in these patients, while the currently available evidence base does not support the use of NaP. For VCE, lower volume PEG appears to be as efficacious as higher volumes traditionally used for colonoscopy preparation. © 2012 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted. Source


Due to professional independence of both midwifes and physicians, the obligation of mutual assistance in normal and pathological births generates conflicts and uncertanties between those two professionals. Although the legal framework seems to be clear, in practice cooperation is often jeopardized by ignoring or simply not knowing the according limits of responsibility. The principles of defining the field of midwifery as well as the criteria for allocating physicians duties and responsibilities in line with legal regulations are discussed in the article. © 2013 Springer-Verlag Berlin Heidelberg. Source


Lohr J.M.,University of Mannheim | Lohr J.M.,Karolinska Institutet | Haas S.L.,University of Mannheim | Haas S.L.,Karolinska Institutet | And 10 more authors.
Annals of Oncology | Year: 2012

Background: Paclitaxel embedded in cationic liposomes (EndoTAG™-1; ET) is an innovative agent targeting tumor endothelial cells. This randomized controlled phase II trial evaluated the safety and efficacy of ET in combination with gemcitabine (GEM) in advanced pancreatic cancer (PDAC). Patients and methods: Chemotherapy-naive patients with locally advanced or metastatic disease were randomly assigned to receive weekly GEM 1000 mg/m. 2 or GEM plus twice-weekly ET 11, 22 or 44 mg/m. 2 for 7 weeks. After a safety run-in of 100 patients, a second cohort continued treatment. End points included overall survival (OS), progression-free survival (PFS), tumor response and safety. Results: Two hundred and twelve patients were randomly allocated to the study and 200 were treated (80% metastatic, 20% locally advanced). Adverse events were manageable and reversible. Transient thrombocytopenia and infusion reactions with chills and pyrexia mostly grade 1 or 2 occurred in the ET groups. Disease control rate after the first treatment cycle was 43% with GEM and 60%, 65% and 52% in the GEM + ET cohorts. Median PFS reached 2.7 compared with 4.1, 4.6 and 4.4 months, respectively. Median OS was 6.8 compared with 8.1, 8.7 and 9.3 months, respectively. Conclusions: Treatment of advanced PDAC with GEM + ET was generally well tolerated. GEM + ET showed beneficial survival and efficacy. A randomized phase III trial should confirm this positive trend. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source


Hartel C.,University of Lubeck | Pagel J.,University of Lubeck | Rupp J.,University of Lubeck | Bendiks M.,University of Lubeck | And 11 more authors.
Journal of Pediatrics | Year: 2014

Objective To evaluate outcome data in an observational cohort of very low birth weight infants of the German Neonatal Network stratified to prophylactic use of Lactobacillus acidophilus/Bifidobacterium infantis probiotics. Study design Within the observational period (September 1, 2010, until December 31, 2012, n = 5351 infants) study centers were categorized into 3 groups based on their choice of Lactobacillus acidophilus/Bifidobacterium infantis use: (1) no prophylactic use (12 centers); (2 a/b) change of strategy nonuser to user during observational period (13 centers); and (3) use before start of observation (21 centers). Primary outcome data of all eligible infants were determined according to center-specific strategy. Results The use of probiotics was associated with a reduced risk for necrotizing enterocolitis surgery (group 1 vs group 3: 4.2 vs 2.6%, P =.028; change of strategy: 6.2 vs 4.0%, P <.001), any abdominal surgery, and hospital mortality. Infants treated with probiotics had improved weight gain/day, and probiotics had no effect on the risk of blood-culture confirmed sepsis. In a multivariable logistic regression analysis, probiotics were protective for necrotizing enterocolitis surgery (OR 0.58, 95% CI 0.37-0.91; P =.017), any abdominal surgery (OR 0.7, 95% CI 0.51-0.95; P =.02), and the combined outcome abdominal surgery and/or death (OR 0.43; 95% CI 0.33-0.56; P <.001). Conclusions Our observational data support the use of Lactobacillus acidophilus/Bifidobacterium infantis probiotics to reduce the risk for gastrointestinal morbidity but not sepsis in very low birth weight infants. Copyright © 2014 Elsevier Inc. All rights reserved. Source

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