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Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA study).


- candidate number1389
- NTR NumberNTR222
- ISRCTNISRCTN79588422
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsZonMw projectnumber: 945-06-901 
- Public TitlePerioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA study).
- Scientific TitlePerioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA study).
- ACRONYMLAFA-study
- hypothesisThat laparoscopic surgery alone or in combination with fast track perioperative care is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease.
- Healt Condition(s) or Problem(s) studiedMalignant colorectal disease
- Inclusion criteria1. Age between 40 and 80 years; 2. Colorectal cancer including colon and rectosigmoid cancers; 3. Informed consent.
- Exclusion criteria1. Prior midline laparotomy; 2. ASA 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jul-2005
- planned closingdate31-dec-2008
- Target number of participants400
- InterventionsLaparoscopic surgery and fast track perioperative care.
- Primary outcome1. Total postoperative 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 outcome1. Morbidity; 2. Patient satisfaction measured by standardised questionnaires; 3. Readmission percentage.
- Timepoints
- Trial web sitehttp://www.lafa-trial.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. W.A. Bemelman
- CONTACT for SCIENTIFIC QUERIESM.D. J. Wind
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground: Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of fast track recovery multimodal programs. Both programs focus on faster recovery and shorter hospital stay. Objectives: To determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease. Patients and Methods: double blinded, multicenter trial with a 2 x 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease viz. right and left colectomy and anterior resection will be randomised to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups (a) open colectomy with standard care (b) open colectomy with fast track program (c) laparoscopic colectomy with standard care and (d) laparoscopic surgery with fast track program. Primary outcome measure are length of postoperative hospital stay including readmission within 30 days, quality of life two weeks after surgery, overall hospital costs. Secondary outcome parameters are morbidity, patient satisfaction and readmission. Data analysis: We anticipate a difference of 4 days between standard care and the fast track laparoscopic group. Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the SF-36 and social functioning can be detected.
- Main changes (audit trail)
- RECORD6-sep-2005 - 18-dec-2006


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