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.
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). 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.
Stinner
B
B
Department of General Surgery, Philipps-University Marburg, Germany.
Bauhofer
A
A
Lorenz
W
W
Rothmund
M
M
Plaul
U
U
Torossian
A
A
Celik
I
I
Sitter
H
H
Koller
M
M
Black
A
A
Duda
D
D
Encke
A
A
Greger
B
B
van Goor
H
H
Hanisch
E
E
Hesterberg
R
R
Klose
K J
KJ
Lacaine
F
F
Lorijn
R H
RH
Margolis
C
C
Neugebauer
E
E
Nyström
P O
PO
Reemst
P H
PH
Schein
M
M
Solovera
J
J
D000465:Algorithms; D000758:Anesthesia; D015179:Colorectal Neoplasms / Q000601:surgery*; D018849:Controlled Clinical Trials as Topic; D019317:Evidence-Based Medicine; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D011183:Postoperative Complications / Q000517:prevention & control*; D011786:Quality Control; D011994:Recombinant Proteins; D012107:Research Design; D012306:Risk
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor