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ISRCTN
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ISRCTN16397735
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DOI
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10.1186/ISRCTN16397735
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Enhanced recovery in colorectal surgery: a multicentre study from the Spanish Working group
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Scientific title
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A multicentre prospective interventional study from the Spanish Working group into enhanced recovery in colorectal surgery
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The implementation of an enhanced recovery after surgery protocol in major colorectal surgery reduces postoperative complications and hospital stays.
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Lay summary
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Ethics approval
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No specific ethical requirements for this study; informed by Hospital Ethical Board that ethics approval was not required as this is an observational non-randomised study based on the best available evidence.
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Study design
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Observational non-randomised study
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Colorectal disease
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Participants - inclusion criteria
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1. Aged 18 years or over, either sex
2. Programmed for surgery for colorectal cancer without the need for a stoma or any further surgical procedure
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Participants - exclusion criteria
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1. Need for emergency surgery
2. American Society of Anaesthesiologists (ASA) class IV
3. Need for a colostomy or ileostomy
4. Inability to provide informed consent
5. Diabetes
6. Slow evacuation previously documented by a digestive medicine unit
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Anticipated start date
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01/01/2008
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Anticipated end date
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31/08/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please contact ard-fast-track@googlegroups.com to request a patient information sheet
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Target number of participants
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300
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Interventions
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Colorectal surgery
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Primary outcome measure(s)
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Morbi-mortality, measured from operation to two months after surgery
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Secondary outcome measure(s)
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Hospital stay, measured from operation up to release from hospital
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Sources of funding
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Investigator initiated and funded (Spain)
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Trial website
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Publications
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Contact name
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Dr
Jose
Ramirez
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Address
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Servicio de Cirugia
Hospital Clinico Universitario
San Juan Bosco 15
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City/town
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Zaragoza
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Zip/Postcode
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50009
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Country
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Spain
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Sponsor
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Spanish Working Group on Multimodal Rehabilitation (Grupo Español de Rehabilitacion Multimodal [GERM]) (Spain)
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Address
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Servicio de Cirugia
Hospital Clinico Universitario
San Juan Bosco 15
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City/town
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Zaragoza
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Zip/Postcode
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50009
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Country
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Spain
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Sponsor website:
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http://ftsurgery.com/
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Date applied
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19/09/2010
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Last edited
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06/10/2010
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Date ISRCTN assigned
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06/10/2010
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