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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
Univ Marburg, Inst Theoret Surg, D-35033 Marburg, Germany Univ Marburg, Dept Gen Surg, D-35032 Marburg, Germany Univ Marburg, Dept Anaesthesia & Intens Care Med, D-35032 Marburg, Germany Bristol Royal Infirm, Dept Anaesthesia, Bristol, Avon, England Rot Kreuz Clin, Dept Surg, Kassel, Germany Univ Frankfurt, Dept Surg, D-6000 Frankfurt, Germany Dept Surg, Lichtenfels, Germany Univ Nijmegen, Med Ctr, Dept Surg, Nijmegen, Netherlands Knappschafts Clin, Dept Surg, Dortmund, Germany St Hildegardes Clin, Dept Anaesthesia, Mainz, Germany Univ Marburg, Dept Radiol, D-35032 Marburg, Germany Hosp Tenon, Dept Surg, Paris, France Amgen Inc Europe, Lucerne, Switzerland Ben Gurion Univ Negev, Fac Hlth Sci, Ctr Med Descis Making, IL-84105 Beer Sheva, Israel Univ Cologne, Dept Surg 2, Biochem & Expt Div, D-5000 Cologne 41, Germany Linkoping Univ, Dept Med Surg Gastroenterol, S-58183 Linkoping, Sweden Diakonissenhuis, Dept Surg, Eindhoven, Netherlands Cornell Univ, New York Methodist Hosp, Dept Surg, Ithaca, NY 14853 USA.
Univ Marburg, Inst Theoret Surg, D-35033 Marburg, Germany Univ Marburg, Dept Gen Surg, D-35032 Marburg, Germany Univ Marburg, Dept Anaesthesia & Intens Care Med, D-35032 Marburg, Germany Bristol Royal Infirm, Dept Anaesthesia, Bristol, Avon, England Rot Kreuz Clin, Dept Surg, Kassel, Germany Univ Frankfurt, Dept Surg, D-6000 Frankfurt, Germany Dept Surg, Lichtenfels, Germany Univ Nijmegen, Med Ctr, Dept Surg, Nijmegen, Netherlands Knappschafts Clin, Dept Surg, Dortmund, Germany St Hildegardes Clin, Dept Anaesthesia, Mainz, Germany Univ Marburg, Dept Radiol, D-35032 Marburg, Germany Hosp Tenon, Dept Surg, Paris, France Amgen Inc Europe, Lucerne, Switzerland Ben Gurion Univ Negev, Fac Hlth Sci, Ctr Med Descis Making, IL-84105 Beer Sheva, Israel Univ Cologne, Dept Surg 2, Biochem & Expt Div, D-5000 Cologne 41, Germany Linkoping Univ, Dept Med Surg Gastroenterol, S-58183 Linkoping, Sweden Diakonissenhuis, Dept Surg, Eindhoven, Netherlands Cornell Univ, New York Methodist Hosp, Dept Surg, Ithaca, NY 14853 USA.
Univ Marburg, Inst Theoret Surg, D-35033 Marburg, Germany Univ Marburg, Dept Gen Surg, D-35032 Marburg, Germany Univ Marburg, Dept Anaesthesia & Intens Care Med, D-35032 Marburg, Germany Bristol Royal Infirm, Dept Anaesthesia, Bristol, Avon, England Rot Kreuz Clin, Dept Surg, Kassel, Germany Univ Frankfurt, Dept Surg, D-6000 Frankfurt, Germany Dept Surg, Lichtenfels, Germany Univ Nijmegen, Med Ctr, Dept Surg, Nijmegen, Netherlands Knappschafts Clin, Dept Surg, Dortmund, Germany St Hildegardes Clin, Dept Anaesthesia, Mainz, Germany Univ Marburg, Dept Radiol, D-35032 Marburg, Germany Hosp Tenon, Dept Surg, Paris, France Amgen Inc Europe, Lucerne, Switzerland Ben Gurion Univ Negev, Fac Hlth Sci, Ctr Med Descis Making, IL-84105 Beer Sheva, Israel Univ Cologne, Dept Surg 2, Biochem & Expt Div, D-5000 Cologne 41, Germany Linkoping Univ, Dept Med Surg Gastroenterol, S-58183 Linkoping, Sweden Diakonissenhuis, Dept Surg, Eindhoven, Netherlands Cornell Univ, New York Methodist Hosp, Dept Surg, Ithaca, NY 14853 USA.
Univ Marburg, Inst Theoret Surg, D-35033 Marburg, Germany Univ Marburg, Dept Gen Surg, D-35032 Marburg, Germany Univ Marburg, Dept Anaesthesia & Intens Care Med, D-35032 Marburg, Germany Bristol Royal Infirm, Dept Anaesthesia, Bristol, Avon, England Rot Kreuz Clin, Dept Surg, Kassel, Germany Univ Frankfurt, Dept Surg, D-6000 Frankfurt, Germany Dept Surg, Lichtenfels, Germany Univ Nijmegen, Med Ctr, Dept Surg, Nijmegen, Netherlands Knappschafts Clin, Dept Surg, Dortmund, Germany St Hildegardes Clin, Dept Anaesthesia, Mainz, Germany Univ Marburg, Dept Radiol, D-35032 Marburg, Germany Hosp Tenon, Dept Surg, Paris, France Amgen Inc Europe, Lucerne, Switzerland Ben Gurion Univ Negev, Fac Hlth Sci, Ctr Med Descis Making, IL-84105 Beer Sheva, Israel Univ Cologne, Dept Surg 2, Biochem & Expt Div, D-5000 Cologne 41, Germany Linkoping Univ, Dept Med Surg Gastroenterol, S-58183 Linkoping, Sweden Diakonissenhuis, Dept Surg, Eindhoven, Netherlands Cornell Univ, New York Methodist Hosp, Dept Surg, Ithaca, NY 14853 USA.
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2001 (English)In: Inflammation Research, ISSN 1023-3830, E-ISSN 1420-908X, Vol. 50, no 5, 233-248 p.Article, review/survey (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2001. Vol. 50, no 5, 233-248 p.
National Category
Medical and Health Sciences
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URN: urn:nbn:se:liu:diva-49241OAI: oai:DiVA.org:liu-49241DiVA: diva2:270137
Available from: 2009-10-11 Created: 2009-10-11 Last updated: 2017-12-12

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Nyström, Per-Olof

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