Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial - Full Text View

Purpose

To investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion.

Condition	Intervention
Elective Colectomie Median Laparotomie	Procedure: Standard Care Procedure: Fast Track care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:

complications until 30 days after surgery according to the zurich classification [ Time Frame: 30 days postoperative ]

Secondary Outcome Measures:

hospital stay, adherence to Fast track protocol [ Time Frame: 30 days ]

Enrollment:	150
Study Start Date:	November 2004
Study Completion Date:	January 2007

Arms	Assigned Interventions
1 Standard Care	Procedure: Standard Care standard fluid regime, delayed feeding
2 Fast Track Care	Procedure: Fast Track care restrictive fluid regime, early oral feeding, enforced mobilisation

Detailed Description:

Our fast track protocol contains the four major components perioperative fluid restriction, epidural analgesia, early oral feeding and enforced mobilisation

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

all patients admitted for open colonic surgery

Exclusion Criteria:

no primary anastomosis and/or stoma rectum resection emergency situation patients not speaking german immobile patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556790

Locations


Switzerland
	Kantonsspital Winterthur
	Winterthur, Switzerland, 8401
	Kantonsspital Olten
	Olten, Switzerland, 4600
	Spital Uster
	Uster, Switzerland, 8610

Sponsors and Collaborators

University of Lausanne Hospitals

University of Zurich

Kantonsspital Olten

Kantonsspital Winterthur

Spital Uster

Investigators


Principal Investigator:	Sven Muller, MD	University of Zurich

More Information

Study ID Numbers:	263/2003 USZ
First Received:	November 9, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00556790
Health Authority:	Switzerland: Swissmedic

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	University of Lausanne Hospitals University of Zurich Kantonsspital Olten Kantonsspital Winterthur Spital Uster
Information provided by:	University of Lausanne Hospitals
ClinicalTrials.gov Identifier:	NCT00556790