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Note: This record shows only 22 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:	13 January 2015
Main ID:	ISRCTN79588422
Date of registration:	20/12/2005
Prospective Registration:	No
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)
Scientific title:
Date of first enrolment:	01/07/2005
Target sample size:	400
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN79588422
Study type:	Interventional
Study design:	Multicentre randomised double-blind active controlled parallel group trial (Treatment)
Phase:

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:

Name:
Address:
Telephone:
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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: Both

Health Condition(s) or Problem(s) studied

Laparoscopic surgery
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)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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