PMID: 11339498May 8, 2001Paper

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 : Official Journal of the European Histamine Research Society ... [et Al.]
Wilfried LorenzD H Wittmann

Abstract

Presentation of a novel study protocol to evalue the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). The rationale and hypothesis are presented in this part of the protocol of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). Part one of this protocol describes the concepts of three major sections of the study: Definition of optimum and sub-optimal recovery after operation. Recovery, as an outcome, is not a simple univariate endpoint, but a complex construction of mechanistic variables (i. e. death, complications and health status assessed by the surgeon), quality of life expressed by the patient, and finally a weighted outcome judgement by both the patient and the surgeon (true endpoint). Its conventional early assessment within 14-28 days is artificial: longer periods (such as 6 months) are needed for the patient to state: "I am now as well as I was before". Identification of suitable target patients: the use of biological response modifiers (immune mod...Continue Reading

Citations

Mar 6, 2008·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·P JestinU Gunnarsson
Jan 24, 2006·Contemporary Clinical Trials·Leslie Ain McClure, Morton B Brown
May 29, 2007·Journal of Pain and Symptom Management·Richard A MularskiRobert S Krouse

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