title: 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: design of the study.
abstract: METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute of Theoretical Surgery, Philipps-University Marburg, Germany. bauhofer@mailer.uni-marburg.de
authors.forename: A
authors.initials: A
authors.lastname: Bauhofer
authors.forename: W
authors.initials: W
authors.lastname: Lorenz
authors.forename: B
authors.initials: B
authors.lastname: Stinner
authors.forename: M
authors.initials: M
authors.lastname: Rothmund
authors.forename: M
authors.initials: M
authors.lastname: Koller
authors.forename: H
authors.initials: H
authors.lastname: Sitter
authors.forename: I
authors.initials: I
authors.lastname: Celik
authors.forename: J R
authors.initials: JR
authors.lastname: Farndon
authors.forename: A
authors.initials: A
authors.lastname: Fingerhut
authors.forename: J M
authors.initials: JM
authors.lastname: Hay
authors.forename: R
authors.initials: R
authors.lastname: Lefering
authors.forename: R
authors.initials: R
authors.lastname: Lorijn
authors.forename: P O
authors.initials: PO
authors.lastname: Nyström
authors.forename: H
authors.initials: H
authors.lastname: Schäfer
authors.forename: M
authors.initials: M
authors.lastname: Schein
authors.forename: J
authors.initials: J
authors.lastname: Solomkin
authors.forename: H
authors.initials: H
authors.lastname: Troidl
authors.forename: H D
authors.initials: HD
authors.lastname: Volk
authors.forename: D H
authors.initials: DH
authors.lastname: Wittmann
authors.forename: J
authors.initials: J
authors.lastname: Wyatt
mesh_terms: D002985:Clinical Protocols; D015179:Colorectal Neoplasms / Q000601:surgery*; D004311:Double-Blind Method; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D017053:Infection Control; D010919:Placebos; D011183:Postoperative Complications / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins; D012107:Research Design; D012307:Risk Factors
chemical_list: D010919:Placebos; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor