Contact information
Type
Scientific
Primary contact
Dr W.A. Bemelman
ORCID ID
Contact details
Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663170
W.A.Bemelman@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR222; ZonMw reference: 945-06-901
Study information
Scientific title
Acronym
LAFA study
Study hypothesis
That laparoscopic surgery alone or in combination with fast track peri-operative care is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised double-blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Laparoscopic surgery
Intervention
Laparoscopic surgery and fast track peri-operative care.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
1. Morbidity
2. Patient satisfaction measured by standardised questionnaires
3. Readmission percentage
Overall trial start date
01/07/2005
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 40 and 80 years
2. Colorectal cancer including colon and rectosigmoid cancers
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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
Recruitment start date
01/07/2005
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary