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

This study has been terminated.
(interim analysis)
Sponsor:
Collaborators:
University of Zurich
Kantonsspital Olten
Kantonsspital Winterthur KSW
Spital Uster
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00556790
First received: November 9, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: 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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
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
Investigators
Principal Investigator: Sven Muller, MD University of Zurich