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 management¶

Abstract

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.

Understanding quality of life in patients with colorectal cancer: comparison of data from a randomised controlled trial, a population based cohort study and the norm reference population

“…The estimation of the sample size, 40 patients per group, was based on the primary endpoint, global quality of life. Surgical treatment and complication management were standardised according to an evidence-based clinical algorithm [8,15,16]. Patients were followed up until six months postoperatively.…”

Antibiotic prophylaxis influences cardiovascular stability in complicated surgery

“…Furthermore, this concept was applied to studies in rodents investigating the effect of the immunomodulating growth factor G-CSF (granulocyte-colony stimulating factor) applied as a prophylaxis on the course and outcome of peritonitis and sepsis in rats [19,22,44]. The results of these pre-clinical experiments in rats were used for the development of a clinical study protocol which was published in three parts [45][46][47] before the prospective, randomised, clinical study was successfully conducted. A preliminary data analysis reveals a good approximation between the preclinical results following the concept of CMRTs and the results of the clinical study using a G-CSF-prophylaxis.…”

Computerized visualization of quality of life data of individual cancer patients ? the QoL-Profiler

“…The third study was a prospective, controlled, randomised trial on preoperative G-CSF administration to improve postoperative recovery [9]. A total of 80 high risk patients (ASA III and IV) with colorectal cancer were included in this study.…”

“…The aim is to give access to QoL-profiles to every physician dealing with the patients. Figure 1 shows the QoL-profile of a patient who was randomized into the G-CSF-study [9]. QoL-assessments were taken at discharge from hospital, as well as two months and six months after operation.…”