NCT00556790

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2007

Completed
Last Updated

November 12, 2007

Status Verified

November 1, 2007

First QC Date

November 9, 2007

Last Update Submit

November 9, 2007

Conditions

Elective ColectomieMedian Laparotomie

Outcome Measures

Primary Outcomes (1)

  • complications until 30 days after surgery according to the zurich classification

    30 days postoperative

Secondary Outcomes (1)

  • hospital stay, adherence to Fast track protocol

    30 days

Study Arms (2)

1

OTHER

Standard Care

Procedure: Standard Care

2

OTHER

Fast Track Care

Procedure: Fast Track care

Interventions

Standard CarePROCEDURE

standard fluid regime, delayed feeding

1
Fast Track carePROCEDURE

restrictive fluid regime, early oral feeding, enforced mobilisation

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients admitted for open colonic surgery

You may not qualify if:

  • no primary anastomosis and/or stoma rectum resection emergency situation patients not speaking german immobile patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Spital Uster

Uster, 8610, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Related Publications (2)

  • Hubner M, Muller S, Schafer M, Clavien PA, Demartines N. Impact of the nutritional risk score in fast-track colon surgery. Dig Surg. 2010;27(5):436-9. doi: 10.1159/000313692. Epub 2010 Nov 5.

    PMID: 21051894DERIVED

  • Muller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1.

    PMID: 19135997DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sven Muller, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 12, 2007

Study Start

November 1, 2004

Study Completion

January 1, 2007

Last Updated

November 12, 2007

Record last verified: 2007-11

Locations

CH(3)