Clinical—Alimentary TractA Fast-Track Program Reduces Complications and Length of Hospital Stay After Open Colonic Surgery
Section snippets
Patients and Eligibility
We conducted a multicenter, randomized trial in 4 surgical departments (teaching hospitals) in Switzerland. Eligible for this trial were patients older than 18 years of age who were undergoing open elective colonic resection with a primary anastomosis. Exclusion criteria were emergency situations, contraindication to epidural anesthesia, scheduled total colectomy or rectum resection, and preoperatively immobile patients. The study was approved by the local ethical committees of the
Results
From November 2004 until October 2006 there were 156 patients who fulfilled inclusion criteria and were assigned randomly to the fast-track and standard care groups. A planned interim analysis was performed after inclusion of one third of the calculated sample size and the study was stopped prematurely after reaching a significant difference for the primary end point according to the O'Brien–Fleming approach. Thus, 151 patients completed the study period (supplementary Table 1; see
Discussion
The results of this randomized multicenter trial indicate that a fast-track program significantly reduces the number of postoperative complications, especially general complications, leading to a shorter hospital stay after elective open colonic surgery. In a multivariate analysis, the present study shows that intraoperative fluid restriction and an effective EDA are significant predictors of reduced postoperative complications. Methodologic limitations of this study, which may cause a bias of
Investigators of the Zurich Fast Track Trial Group
Sven Muller, MD, and Nicolas Demartines, MD, Department of Visceral Surgery, CHUV, Lausanne, and formerly Visceral and Transplant Surgery, University Hospital Zurich; Pierre A. Clavien, MD, PhD, Visceral and Transplant Surgery, University Hospital Zurich; Marco P. Zalunardo, MD, Institute of Anesthesiology, University Hospital Zurich; Marco Decurtins, MD, Department of Surgery, Kantonsspital Winterthur; Lukas Eisner, MD, Department of Surgery, Kantonsspital Olten; Italo Castelli, MD, Department
Acknowledgements
Members of the Zurich Fast Track Study Group are listed at the end of the article.
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Trial Registration: http://www.clinicaltrials.gov; identifier: NCT00556790.
Dr Muller designed the study, analyzed the data, performed statistical analysis and drafted the manuscript and had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr Zalunardo, Dr Hubner, and Dr Clavien participated in the design and coordination of the study and data analyses and helped to draft the manuscript. Dr Demartines designed the study, analyzed the data, and helped to draft the manuscript. All authors read and approved the final manuscript.
Conflicts of interest The authors disclose the following: Dr Muller, Dr Clavien, and Dr Demartines have received research support from Fresenius Kabi, Stans, Switzerland. Dr Zalunardo and Dr Hubner disclose no conflicts.