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

Overview

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.

Full Title of Study: “Fast Track in Open Colonic Surgery – A Multicentric Randomized Controlled Trial”

Study Type

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

Detailed Description

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

Interventions

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

Arms, Groups and Cohorts

  • Other: 1
    • Standard Care
  • Other: 2
    • Fast Track Care

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Lausanne Hospitals
  • Collaborator
    • University of Zurich
  • Overall Official(s)
    • Sven Muller, MD, Principal Investigator, University of Zurich

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