Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patientswith 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 andquality management

General design: Presentation of a new type of a study protocol for evaluati on of the effectiveness of an immune modifier (rhG-CSF, filgrastim): preven tion of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperativ e risk (ASA 3 and 4). A randomised placebo controlled, double-blinded, sing le-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 quali ty management. Objective: In part three of the protocol, the three major sections include: - The course of the individual patient using a comprehensive graphic displa y, including the perioperative period, hospital stay and post discharge out come. - A center based clinical practice guideline for the management of the most important postoperative complication anastomotic leakage - including evide nce 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 bet ter structured (reduction of variance) to achieve uniform patient managemen t in a complex clinical scenario. This new type of a single-centre trial ai ms to reduce the gap between animal experiments and clinical trials or - if it fails - at least demonstrates new ways for explaining the failures.