Advertisement

Inflammation Research

, Volume 50, Issue 5, pp 233–248 | Cite as

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¶

  • B. Stinner
  • A. Bauhofer
  • W. Lorenz
  • M. Rothmund
  • U. Plaul
  • A. Torossian
  • I. Celik
  • H. Sitter
  • M. Koller
  • A. Black
  • D. Duda
  • A. Encke
  • B. Greger
  • H. van Goor
  • E. Hanisch
  • R. Hesterberg
  • K. J. Klose
  • F. Lacaine
  • R.H.W. Lorijn
  • C. Margolis
  • E. Neugebauer
  • P.O. Nyström
  • P.H.M. Reemst
  • M. Schein
  • J. Solovera
  •  Lucerne Group for Consensus-assisted Development of the Study Protocol on Prevention of Abdominal Sepsis: Example G-CSF

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.¶

Key words: G-CSF - Postoperative infections - Postoperative recovery - Colorectal cancer - Complication guideline 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Copyright information

© Birkhäuser Verlag, 2001

Authors and Affiliations

  • B. Stinner
    • 1
  • A. Bauhofer
    • 2
  • W. Lorenz
    • 2
  • M. Rothmund
    • 1
  • U. Plaul
    • 1
  • A. Torossian
    • 3
  • I. Celik
    • 2
  • H. Sitter
    • 2
  • M. Koller
    • 2
  • A. Black
    • 4
  • D. Duda
    • 5
  • A. Encke
    • 6
  • B. Greger
    • 7
  • H. van Goor
    • 8
  • E. Hanisch
    • 8
  • R. Hesterberg
    • 9
  • K. J. Klose
    • 10
  • F. Lacaine
    • 11
  • R.H.W. Lorijn
    • 12
  • C. Margolis
    • 13
  • E. Neugebauer
    • 14
  • P.O. Nyström
    • 15
  • P.H.M. Reemst
    • 16
  • M. Schein
    • 17
  • J. Solovera
    • 18
  •  Lucerne Group for Consensus-assisted Development of the Study Protocol on Prevention of Abdominal Sepsis: Example G-CSF
    • 18
  1. 1.Department of General Surgery, Philipps-University Marburg, Germany DE
  2. 2.Institute of Theoretical Surgery, Philipps-University Marburg, Baldingerstrasse, 35033 Marburg, Germany, Fax: +49 6421 286 6252, e-mail: bauhofer@mailer.uni-marburg.de DE
  3. 3.Department of Anaesthesia and Intensive Care Medicine, Philipps-University Marburg, Germany DE
  4. 4.Department of Anaesthesia, Bristol Royal Infirmary, Bristol, Great Britain GB
  5. 5.Department of Surgery, Rot Kreuz Clinic, Kassel, Germany DE
  6. 6.Department of Surgery, University of Frankfurt, Germany DE
  7. 7.Department of Surgery, Lichtenfels, Germany DE
  8. 8.Department of Surgery, University Medical Center Nijmegen, The Netherlands NL
  9. 9.Department of Anaesthesia, St. Hildegardes Clinic, Mainz, Germany DE
  10. 10.Department of Radiology, Philipps-University Marburg, Germany DE
  11. 11.Department of Surgery, Hospital Tenon, Paris, France FR
  12. 12.AMGEN - Inc. Europe, Lucerne, Switzerland CH
  13. 13.Center of Medical Decision Making, Faculty of Health Science, Ben Gurion University, Beer Sheva, Israel IL
  14. 14.Biochemical and Experimental Division, Surgical Department II, University of Cologne, Germany DE
  15. 15.Department of Medico-Surgical Gastroenterology, University of Linköping, Sweden SE
  16. 16.Department of Surgery, Diakonissenhuis, Eindhoven, The Netherlands NL
  17. 17.Department of Surgery, New York Methodist Hospital, Cornell University, USA US
  18. 18.Bartscherer (Marburg), Bauer (Altötting), Dietz (Delmenhorst), Farndon (Bristol), Fingerhut, Fagniez (Paris), Hartel (München), Hay (Paris), Horeyseck (Siegburg), Izbicki, Schneider (Hamburg), Kisker, Krack, Middeke (Marburg), Lefering (Cologne), Menger (Homburg Saar), Millat (Montpellier), Pliskin (Beer Sheva), Solomkin (Cincinnatti), Troidl (Cologne), Platzer (Basle), van Deventer (Amsterdam), Voigt (Marburg), Volk (Berlin), Wendel, Hartung (Konstanz), Werdan (Halle), Willatts, Wyatt (Bristol), Wittmann (Milwaukee).DE

Personalised recommendations