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

Background: 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.

That 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.

Laparoscopic surgery and fast track perioperative care.