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

Elective Colectomie Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00556790
• Other study ID #: 263/2003 USZ
• Status: Terminated
• Phase: N/A
• First received: November 9, 2007
• Last updated: November 9, 2007
• Start date: November 2004
• Est. completion date: January 2007

Study information

• Verified date: November 2007
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elective Colectomie
• Median Laparotomie

Intervention

Procedure:
• Standard Care
standard fluid regime, delayed feeding
• Fast Track care
restrictive fluid regime, early oral feeding, enforced mobilisation

Locations

Country	Name	City	State
Switzerland	Kantonsspital Olten	Olten
Switzerland	Spital Uster	Uster
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (5)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Kantonsspital Olten, Kantonsspital Winterthur KSW, Spital Uster, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications until 30 days after surgery according to the zurich classification		30 days postoperative
Secondary	hospital stay, adherence to Fast track protocol		30 days