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21 October 2014 
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Enhanced recovery in colorectal surgery: a multicentre study from the Spanish Working group
ISRCTN ISRCTN16397735
DOI 10.1186/ISRCTN16397735
ClinicalTrials.gov identifier
EudraCT number
Public title Enhanced recovery in colorectal surgery: a multicentre study from the Spanish Working group
Scientific title A multicentre prospective interventional study from the Spanish Working group into enhanced recovery in colorectal surgery
Acronym N/A
Serial number at source N/A
Study hypothesis The implementation of an enhanced recovery after surgery protocol in major colorectal surgery reduces postoperative complications and hospital stays.
Lay summary
Ethics approval 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.
Study design Observational non-randomised study
Countries of recruitment Spain
Disease/condition/study domain Colorectal disease
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 01/01/2008
Anticipated end date 31/08/2010
Status of trial Completed
Patient information material Not available in web format, please contact ard-fast-track@googlegroups.com to request a patient information sheet
Target number of participants 300
Interventions Colorectal surgery
Primary outcome measure(s) Morbi-mortality, measured from operation to two months after surgery
Secondary outcome measure(s) Hospital stay, measured from operation up to release from hospital
Sources of funding Investigator initiated and funded (Spain)
Trial website
Publications
Contact name Dr  Jose  Ramirez
  Address Servicio de Cirugia
Hospital Clinico Universitario
San Juan Bosco 15
  City/town Zaragoza
  Zip/Postcode 50009
  Country Spain
Sponsor Spanish Working Group on Multimodal Rehabilitation (Grupo Español de Rehabilitacion Multimodal [GERM]) (Spain)
  Address Servicio de Cirugia
Hospital Clinico Universitario
San Juan Bosco 15
  City/town Zaragoza
  Zip/Postcode 50009
  Country Spain
  Sponsor website: http://ftsurgery.com/
Date applied 19/09/2010
Last edited 06/10/2010
Date ISRCTN assigned 06/10/2010
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