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

November 9, 2007 updated by: University of Lausanne Hospitals
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Standard Care
Procedure: Standard Care
standard fluid regime, delayed feeding
Other: 2
Fast Track Care
Procedure: Fast Track care
restrictive fluid regime, early oral feeding, enforced mobilisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complications until 30 days after surgery according to the zurich classification
Time Frame: 30 days postoperative
30 days postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
hospital stay, adherence to Fast track protocol
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Collaborators

University of Zurich
Kantonsspital Winterthur KSW
Kantonsspital Olten
Spital Uster

Investigators

  • Principal Investigator: Sven Muller, MD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 12, 2007

Last Update Submitted That Met QC Criteria

November 9, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • 263/2003 USZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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