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
Secondary identifying numbers NTR222; ZonMw reference: 945-06-901
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
13/05/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Study website

Contact information

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

Study information

Study designMulticentre randomised double-blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymLAFA study
Study objectivesThat 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) studiedLaparoscopic surgery
InterventionLaparoscopic surgery and fast track peri-operative care.
Intervention typeProcedure/Surgery
Primary outcome measure1. 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 measures1. Morbidity
2. Patient satisfaction measured by standardised questionnaires
3. Readmission percentage
Overall study start date01/07/2005
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteria1. Aged between 40 and 80 years
2. Colorectal cancer including colon and rectosigmoid cancers
3. Informed consent
Key exclusion criteria1. 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 enrolment01/07/2005
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan