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

NCT ID: NCT00556790

Last Updated: 2007-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Elective Colectomie Median Laparotomie

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard Care

Group Type OTHER

Standard Care

Intervention Type PROCEDURE

standard fluid regime, delayed feeding

2

Fast Track Care

Group Type OTHER

Fast Track care

Intervention Type PROCEDURE

restrictive fluid regime, early oral feeding, enforced mobilisation

Interventions

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Standard Care

standard fluid regime, delayed feeding

Intervention Type PROCEDURE

Fast Track care

restrictive fluid regime, early oral feeding, enforced mobilisation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Kantonsspital Olten

OTHER

Sponsor Role collaborator

Kantonsspital Winterthur KSW

OTHER

Sponsor Role collaborator

Spital Uster

UNKNOWN

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role lead

Principal Investigators

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Sven Muller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Kantonsspital Olten

Olten, , Switzerland

Site Status

Spital Uster

Uster, , Switzerland

Site Status

Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 21051894 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19135997 (View on PubMed)

Other Identifiers

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263/2003 USZ

Identifier Type: -

Identifier Source: org_study_id