Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Laparoscopic surgery
Intervention
Laparoscopic surgery and fast track peri-operative care.
Intervention type
Procedure/Surgery
Primary outcome measure
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 study start date
01/07/2005
Overall study end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 40 and 80 years
2. Colorectal cancer including colon and rectosigmoid cancers
3. Informed consent
Participant type(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|