Peri-operative strategy in colonic surgery: LAparoscopy and/or FAst track multimodal management versus standard care (LAFA study)

ISRCTN	ISRCTN79588422
DOI	https://doi.org/10.1186/ISRCTN79588422
Protocol serial number	NTR222; ZonMw reference: 945-06-901
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr W.A. Bemelman
Scientific

Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5663170
Email	W.A.Bemelman@amc.uva.nl

Primary study design	Interventional
Study design	Multicentre randomised double-blind active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	LAFA study
Study objectives	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
Health condition(s) or problem(s) studied	Laparoscopic surgery
Intervention	Laparoscopic surgery and fast track peri-operative care.
Intervention type	Procedure/Surgery
Primary outcome measure(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
Key secondary outcome measure(s)	1. Morbidity 2. Patient satisfaction measured by standardised questionnaires 3. Readmission percentage
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key inclusion criteria	1. Aged between 40 and 80 years 2. Colorectal cancer including colon and rectosigmoid cancers 3. Informed consent
Key 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
Date of first enrolment	01/07/2005
Date of final enrolment	31/12/2008

Academic Medical Centre

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Study website	Study website	11/11/2025	11/11/2025	No	Yes