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

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ClinicalTrials.gov Identifier: NCT00556790
Recruitment Status : Terminated (interim analysis)
First Posted : November 12, 2007
Last Update Posted : November 12, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Elective Colectomie Median Laparotomie Procedure: Standard Care Procedure: Fast Track care

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial
Study Start Date : November 2004
Study Completion Date : January 2007
Arms and Interventions

Arm Intervention/treatment
Standard Care
Procedure: Standard Care
standard fluid regime, delayed feeding
Fast Track Care
Procedure: Fast Track care
restrictive fluid regime, early oral feeding, enforced mobilisation

Outcome Measures

Primary Outcome Measures :
  1. complications until 30 days after surgery according to the zurich classification [ Time Frame: 30 days postoperative ]

Secondary Outcome Measures :
  1. hospital stay, adherence to Fast track protocol [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556790

Kantonsspital Olten
Olten, Switzerland, 4600
Spital Uster
Uster, Switzerland, 8610
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Sponsors and Collaborators
University of Lausanne Hospitals
University of Zurich
Kantonsspital Olten
Kantonsspital Winterthur KSW
Spital Uster
Principal Investigator: Sven Muller, MD University of Zurich