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 for a controlled clinical trial developed by consensus of an international study group: Part two

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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 for a controlled clinical trial developed by consensus of an international study group : Part two

Bauhofer, A. (författare): Institute of Theoretical Surgery, Philipps-University Marburg, Baldingerstrasse, 35033 Marburg, Germany

Lorenz, W. (författare): Institute of Theoretical Surgery, Philipps-University Marburg, Baldingerstrasse, 35033 Marburg, Germany

Stinner, B. (författare): Department of General Surgery, Philipps-University Marburg, Germany

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Rothmund, M. (författare): Department of General Surgery, Philipps-University Marburg, Germany

Koller, M. (författare): Institute of Theoretical Surgery, Philipps-University Marburg, Baldingerstrasse, 35033 Marburg, Germany

Sitter, H. (författare): Institute of Theoretical Surgery, Philipps-University Marburg, Baldingerstrasse, 35033 Marburg, Germany

Celik, I. (författare): Institute of Theoretical Surgery, Philipps-University Marburg, Baldingerstrasse, 35033 Marburg, Germany

Farndon, J.R. (författare): Department of Surgery, Bristol Royal Infirmary, Bristol, United Kingdom

Fingerhut, A. (författare): Department of Surgery, Centre Hospitalier Intercommunal, Poissy, France

Hay, J.M. (författare): Department of Surgery, Hopital Louis Mourier, Colombes, France

Lefering, R. (författare): 2nd Department of Surgery, University of Cologne, Germany

Lorijn, R. (författare): AMGEN Europe, Lucerne, Switzerland

Nyström, Per-Olof (författare): Östergötlands Läns Landsting,Linköpings universitet,Hälsouniversitetet,Kirurgi,Kirurgiska kliniken i Östergötland med verksamhet i Linköping, Norrköping och Motala

Schafer, H. (författare): Schäfer, H., Institute of Medical Biometrics and Epidemiology, Philipps-University Marburg, Germany

Schein, M. (författare): Department of Surgery, New York Methodist Hospital, Cornell University, United States

Solomkin, J. (författare): Department of Surgery, University of Cincinnati, College of Medicine, United States

Troidl, H. (författare): 2nd Department of Surgery, University of Cologne, Germany

Volk, H.-D. (författare): Institute of Medical Immunology, Humboldt-University Berlin, Germany

Wittmann, D.H. (författare): Department of Surgery, Medical College of Wisconsin, Milwaukee, United States

Wyatt, J. (författare): School of Public Policy, University College London, United Kingdom

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(creator_code:org_t)

Springer Science and Business Media LLC, 2001
2001
Engelska.
Ingår i: Inflammation Research. - : Springer Science and Business Media LLC. - 1023-3830 .- 1420-908X. ; 50:4, s. 187-205

Relaterad länk:: https://urn.kb.se/re...; visa fler...; https://doi.org/10.1...; visa färre...

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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) This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). Objective: The trial design includes the following elements for a prototype protocol: - The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). - Patients are allocated by random to the control or treatment group. - The double blinding strategy of the trial is assessed by psychometric indices - An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. - Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. Conclusion: This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

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Av författaren/redakt...: Bauhofer, A.; Lorenz, W.; Stinner, B.; Rothmund, M.; Koller, M.; Sitter, H.; visa fler...; Celik, I.; Farndon, J.R.; Fingerhut, A.; Hay, J.M.; Lefering, R.; Lorijn, R.; Nyström, Per-Olo ...; Schafer, H.; Schein, M.; Solomkin, J.; Troidl, H.; Volk, H.-D.; Wittmann, D.H.; Wyatt, J.; visa färre...

Artiklar i publikationen: Inflammation Res ...

Av lärosätet: Linköpings universitet

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