The Experts below are selected from a list of 169491 Experts worldwide ranked by ideXlab platform

H Sitter - One of the best experts on this subject based on the ideXlab platform.

  • 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 manage
    Inflammation Research, 2001
    Co-Authors: B Stinner, A Bauhofer, W Lorenz, M Rothmund, U Plaul, A Torossian, I Celik, H Sitter, M Koller, A Black
    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.

  • 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 one rationale and hypothesis
    Inflammation Research, 2001
    Co-Authors: W Lorenz, B Stinner, A Bauhofer, M Rothmund, I Celik, M Koller, A Fingerhut, R H W Lorijn, P O Nystrom, H Sitter
    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). 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.¶

W Lorenz - One of the best experts on this subject based on the ideXlab platform.

  • 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 manage
    Inflammation Research, 2001
    Co-Authors: B Stinner, A Bauhofer, W Lorenz, M Rothmund, U Plaul, A Torossian, I Celik, H Sitter, M Koller, A Black
    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.

  • 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 one rationale and hypothesis
    Inflammation Research, 2001
    Co-Authors: W Lorenz, B Stinner, A Bauhofer, M Rothmund, I Celik, M Koller, A Fingerhut, R H W Lorijn, P O Nystrom, H Sitter
    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). 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.¶

B Stinner - One of the best experts on this subject based on the ideXlab platform.

  • 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 manage
    Inflammation Research, 2001
    Co-Authors: B Stinner, A Bauhofer, W Lorenz, M Rothmund, U Plaul, A Torossian, I Celik, H Sitter, M Koller, A Black
    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.

  • 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 one rationale and hypothesis
    Inflammation Research, 2001
    Co-Authors: W Lorenz, B Stinner, A Bauhofer, M Rothmund, I Celik, M Koller, A Fingerhut, R H W Lorijn, P O Nystrom, H Sitter
    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). 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.¶

M Rothmund - One of the best experts on this subject based on the ideXlab platform.

  • 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 manage
    Inflammation Research, 2001
    Co-Authors: B Stinner, A Bauhofer, W Lorenz, M Rothmund, U Plaul, A Torossian, I Celik, H Sitter, M Koller, A Black
    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.

  • 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 one rationale and hypothesis
    Inflammation Research, 2001
    Co-Authors: W Lorenz, B Stinner, A Bauhofer, M Rothmund, I Celik, M Koller, A Fingerhut, R H W Lorijn, P O Nystrom, H Sitter
    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). 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.¶

M Koller - One of the best experts on this subject based on the ideXlab platform.

  • 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 manage
    Inflammation Research, 2001
    Co-Authors: B Stinner, A Bauhofer, W Lorenz, M Rothmund, U Plaul, A Torossian, I Celik, H Sitter, M Koller, A Black
    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.

  • 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 one rationale and hypothesis
    Inflammation Research, 2001
    Co-Authors: W Lorenz, B Stinner, A Bauhofer, M Rothmund, I Celik, M Koller, A Fingerhut, R H W Lorijn, P O Nystrom, H Sitter
    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). 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.¶