In what case do you like reading so much? What about the type of the guide to clinical preventive services book? The needs to read? Well, everybody has their own reason why should read some books. Mostly, it will relate to their necessity to get knowledge from the book and want to read just to get entertainment. Novels, story book, and other entertaining books become so popular this day. Besides, the scientific books will also be the best reason to choose, especially for the students, teachers, doctors, businessman, and other professions who are fond of reading.

Guide to Clinical Preventive Services

BACKGROUND: With introduction of the total mesorectal excision technique and preoperative radiotherapy in rectal cancer surgery, the local recurrence rate has decreased and the overall survival has ...

Risk factors for anastomotic leakage after rectal cancer surgery: a case-control study.

Background:

The value of peritoneal lavage for intra-abdominal contamination and infection has never been proven scientifically. In contrast, the stimulation of host defence mechanisms with cytokines such as granulocyte colony-stimulating factor (G-CSF) has appeared promising in recent clinical trials.



Methods:

Clinic modelling randomized trials (CMRTs), which model the complexity of the clinical reality, were used in rats in which peritoneal contamination and infection (PCI) was produced with human stool bacteria. The following groups were compared: trial 1, intraoperative peritoneal lavage with saline versus taurolin (18 rats per group); trial 2, no lavage versus saline lavage versus saline lavage plus subcutaneous administration of G-CSF (18 rats per group); trial 3, lavage with saline versus no lavage (30 rats per group). The primary endpoint was mortality at 120 h. Secondary endpoints were the phagocytic activity of granulocytes, and systemic and peritoneal cytokine levels.



Results:

In trial 1 lavage with taurolin was not superior to that with saline (five of 18 versus eight of 18 animals survived; P = 0·32). In trial 2, six of 18 animals having no lavage and three of 18 receiving saline lavage survived. The combination of lavage and G-CSF increased the number of animals surviving to 11 of 18 (P < 0·05). Lavage combined with G-CSF stimulated granulocyte phagocytic activity (P < 0·01) and reduced the levels of interleukin (IL) 6 (P < 0·01) and tumour necrosis factor α (P < 0·05) in peritoneal fluid, as well as plasma levels of IL-6 (P < 0·05) and IL-10 (P < 0·01). In trial 3, survival was not significantly different in animals having lavage (14 of 30) and no lavage (19 of 30) (P = 0·14).



Conclusion:

In these CMRTs of intra-abdominal contamination and infection, peritoneal lavage was not beneficial, but when lavage was combined with subcutaneous administration of G-CSF mortality was reduced and the local and systemic cytokine response was downgraded. Results from these CMRTs were used directly to define the trial conditions of a randomized clinical trial with G-CSF. Peritoneal lavage is not recommended. © 2002 British Journal of Surgery Society Ltd

Granulocyte colony-stimulating factor but not peritoneal lavage increases survival rate after experimental abdominal contamination and infection.

Perioperative prophylaxis with granulocyte colony-stimulating factor (G-CSF) in high-risk colorectal cancer patients for an improved recovery: A randomized, controlled trial

General design: 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). Objective: 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 modulators) in addition to traditional prophylaxes (i. e. antibiotics, heparin, volume substitutes) may improve postoperative outcome in appropriate selected patients with reduced host defence and increased immunological stress response, but these have to be defined. Patients classified as ASA 3 and 4 (American Society for Anaesthesiologists) and with colorectal cancer will be studied to prove this hypothesis. Choice of biological response modifier: - Filgrastim has been chosen as an example of a biological response modifier because it was effective in a new study type, clinic-modelling randomised trials in rodents, and has shown promise in some clinical trials for indications other than preoperative prophylaxis. It has also enhanced host defence and has been anti-inflammatory in basic research. Conclusion: The following hypothesis will be tested in patients with operations for colorectal cancer and increased preoperative risk (ASA 3 and 4): is the outcome as evaluated by the hermeneutic endpoint (quality of life expressed by the patient) and mechanistic endpoints (mortality rate, complication rate, relative hospital stay, assessed by the doctor) improved in the group receiving filgrastim prophylaxis in comparison with the placebo group? Quality of life will be the first primary endpoint in the hierarchical, statistical testing of confirmatory analysis.

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) : Part one

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 three: individual patient, complication algorithm and quality manage.

Modelle zur Evaluation von Therapieablaufen (Leitlinien, klinische Algorithmen) werden heute in der Gesundheitsforschung und -politik eindringlich gefordert. Was aber fehlt, sind die praktischen Anwendungen von Evaluation. Die Nation ist gespalten in fordernde Theoretiker und desinteressierte Kliniker. Um diesen Gegensatz zu uberwinden, hat sich die Luzerngruppe fur Sepsisforschung dafur engagiert, Leitlinien bei Sepsis fur den taglichen Gebrauch und fur kontrollierte Studien zu entwickeln. Ihr gegenwartiges Konzept fust auf der Definition des Systemic Inflammatory Response Syndroms (SIRS). - Jeder Chirurg hat eine eigene feste Vorstellung von Sepsis. Dies wurde durch eine multizentrische Studie an 22 Kliniken, davon 3 aus den USA und 19 aus Europa, an fallspezifischen Managementleitlinien bestatigt. Die Leitlinien fur Sepsistherapie variierten erheblich zwischen den Zentren. Die Luzerngruppe machte nicht nur diese Heterogenitat deutlich, sondern wies auch in einem nominalen Gruppenprozes (Delbecq) den Weg zum Konsens.

Evaluationsmodelle zur Therapieplanung/Standardisierung am Beispiel der Sepsis

Models of evaluation in therapeutic management pathways (practice guidelines, clinical algorithms) are demanded today, both by public health research and health policy. However, practical achievements are lacking. To overcome this controversy, the Lucerne Study Group on Sepsis Research was founded to develop guidelines in accordance with a series of official groups. It was shown that there was no agreement between the providers and the daily users. However, every surgeon has a firm, personal view about sepsis.

E. Hanisch

Papers

Evaluationsmodelle zur Therapieplanung/Standardisierung am Beispiel der Sepsis

[Evaluation models for therapy planning/standardization exemplified by infection].