Fast Track in Open Colonic Surgery - A Multicentric Rando... | NCT00556790

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

NCT00556790

Sponsor

University of Lausanne Hospitals

Status

Terminated

Last Update Posted

Nov 12, 2007Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Elective Colectomie
Median Laparotomie

Interventions

Standard Care
Fast Track care

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

interim analysis

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Nov 9, 2007

First Submission Date that Met QC Criteria

Nov 9, 2007

First Posted Date

Nov 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2007

Last Update Posted Date

Nov 12, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Name	Class
University of Zurich	OTHER
Kantonsspital Olten	OTHER
Kantonsspital Winterthur KSW	OTHER
Spital Uster

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Standard Care	Procedure: Standard Care
2	Other	Fast Track Care	Procedure: Fast Track care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Care	Procedure	standard fluid regime, delayed feeding	1
Fast Track care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complications until 30 days after surgery according to the zurich classification		30 days postoperative

Secondary Outcomes

Measure	Description	Time Frame
hospital stay, adherence to Fast track protocol		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sven Muller, MD	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Olten		Olten		4600	Switzerland
Spital Uster

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21051894	Derived	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.
19135997	Derived	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.

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation