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- Stinner, B, et al.
(author)
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Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4) - Protocol of a controlled clinical trial developed by consensus of an international study group Part three : individual patient, complication algorithm and quality management
- 2001
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In: Inflammation Research. - 1023-3830 .- 1420-908X. ; 50:5, s. 233-248
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Research review (peer-reviewed)abstract
- General design: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). A randomised placebo controlled, double-blinded, single-centre study is performed at an University Hospital (n = 40 patients for each group). This part presents the course of the individual patient and a complication algorithm for the management of anastomotic leakage and quality management. Objective: In part three of the protocol, the three major sections include: - The course of the individual patient using a comprehensive graphic display, including the perioperative period, hospital stay and post discharge outcome. - A center based clinical practice guideline for the management of the most important postoperative complication anastomotic leakage - including evidence based support for each step of the algorithm. - Data management, ethics and organisational structure. Conclusions: Future studies with immune modifiers will also fail if not better structured (reduction of variance) to achieve uniform patient management in a complex clinical scenario. This new type of a single-centre trial aims to reduce the gap between animal experiments and clinical trials or - if it fails - at least demonstrates new ways for explaining the failures.
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- Reijnen, M M, et al.
(author)
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The antiadhesive agent sodium hyaluronate increases the proliferation rate of human peritoneal mesothelial cells.
- 2000
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In: Fertility and sterility. - 0015-0282. ; 74:1, s. 146-51
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Journal article (peer-reviewed)abstract
- Design: Controlled laboratory experiment. Setting: A university hospital. Patient(s): Five patients undergoing colorectal surgery for noninfectious reasons. Intervention(s): Human peritoneal mesothelial cells were harvested from patients undergoing a laparotomy for noninfectious reasons. Cells, both nonattached and attached, were incubated for 4 and 24 hours with different concentrations of sodium hyaluronate. Thereafter, the cell proliferation rate was measured by XTT (2,3-bis-(2-methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide) colorimetric assay. To mimic peritoneal injury, the cells were exposed to tumor necrosis factor α and/or lipopolysaccharide and were incubated immediately or after 24 hours of exposure to 0% or 0.2% sodium hyaluronate. Afterward, the cell proliferation rate was measured. Main Outcome Measure(s): Proliferation rate measured by XTT assay. Result(s): Sodium hyaluronate significantly increased the proliferation rate of mesothelial cells, both in a nonattached (P<.005) and attached (P<.001) state. Exposure of the mesothelial cells to tumor necrosis factor α and/or lipopolysaccharide diminished the cells’ proliferation rate. However, incubation of these exposed cells with 0.2% sodium hyaluronate significantly increased the proliferation rate, regardless of whether the sodium hyaluronate was added immediately (P<.001) or after 24 hours (P<.001). Conclusion(s): Sodium hyaluronate increases the proliferation rate of human peritoneal mesothelial cells, both attached and nonattached, under normal conditions and after stimulation with tumor necrosis factor α and/or lipopolysaccharide.
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