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
Contact information
Dr W.A. Bemelman
Scientific
Scientific
Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5663170 |
|---|---|
| W.A.Bemelman@amc.uva.nl |
Study information
| 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 |
| 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 | 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 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
