World Health Organization site
Skip Navigation Links

Main
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 7 April 2014
Main ID:  ISRCTN79588422
Date of registration: 20/12/2005
Primary sponsor: Academic Medical Centre (AMC) (Netherlands)
Public title: Peri-operative strategy in colonic surgery: LAparoscopy and/or FAst track multimodal management versus standard care (LAFA study) LAFA study
Scientific title:
Date of first enrolment: Jul 1 2005
Target sample size: 400
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN79588422
Study type:  Interventional
Study design:  Multicentre randomised double-blind active controlled parallel group trial  
Countries of recruitment
Netherlands
Contacts
Name: W.A.  Bemelman
Address:  Academic Medical Centre P.O. Box 22660 1100 DD Amsterdam Netherlands
Telephone: +31 (0)20 5663170
Email: W.A.Bemelman@amc.uva.nl
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Aged between 40 and 80 years
2. Colorectal cancer including colon and rectosigmoid cancers
3. Informed consent

Exclusion criteria: 1. Prior midline laparotomy
2. American Society of Anaesthesiologists (ASA) grade IV
3. Laparoscopic surgeon not available
4. Prior upper and/or lower midline laparotomy
5. Emergency colectomy
6. Contraindications for epidural (coagulation disorders)
7. Planned stoma


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Laparoscopic surgery
Intervention(s)
Laparoscopic surgery and fast track peri-operative care.
Primary Outcome(s)
1. Total post-operative hospital stay including readmission within 30 days
2. Quality of life measured by validated questionnaires (SF-36/Gigli) at two and four weeks after surgery
3. Medical and non-medical costs
Secondary Outcome(s)
1. Morbidity
2. Patient satisfaction measured by standardised questionnaires
3. Readmission percentage
Secondary ID(s)
NTR222; ZonMw reference: 945-06-901
Source(s) of Monetary Support
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Secondary Sponsor(s)
N/A
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history