Zhou et al. BMC Cancer 2011, 11:494 http://www.biomedcentral.com/1471-2407/11/494 Page 7 of 10 Groups Surgery Perioperative Treatment Discharge Chemotherapy Endpoints Outpatients with Colorectal Cancer Eligibility Inclusion Exclusion Informed Consent Randomization by random number generated by the SPSS 16.0 II Open Surgery I III IV Laparoscopic surgery Fast Track Treatment Laparoscopic surgery Conventional Treatment Open Surgery Meet the discharge criteria I and II groups Stage III and stage II with high-risks III and IV groups XELOX (CapeOX): Repeat every 3 weeks, for 8 cycles mFOLFOX6: Repeat every 2 weeks, for 12 cycles Primary Endpoint: Hospitalization day Secondary Endpoints: 1. Quality of life; 2. Chemotherapy related adverse event; 3. Surgical complications; 4. Hospitalization costs Figure 1 The FTMDT trial flowchart. days. According to our previous research [27], the hospital stay of laparoscopic and open surgery with conventional perioperative treatment is 12 and 14 days. mFolfox6 chemotherapy requires at least 3 hos- pitalization days for each cycle, totally 12 cycles. So, we calculate the hospital stay of III and IV group is 48 and 50 days. With the standard deviation of 6 days of mean hospi- talization days, a total sample size of 218 would have a power of > 0.85 to detect a minimum reduction of 2 days in hospital stay among the 4 groups, using a 5% significance level. The III stage or high-risk II stage account for 64% of the total colorectal cancer patients [28], and these patients need the adjuvant chemotherapy according to the NCCN Clinical Practice Guidelines in Oncology-Colon Cancer Guideline 2009 (Version 2.2009) [29]. For this trial we will enroll 340 patients and have 85 patients in each group. Economic evaluation As one of the secondary outcomes, we would analyze the balance between the reduction of hospitalization days and the hospitalization cost, and evaluate whether or not FTMDT is a more economical colorectal disease treatment model.