Zhou et al. BMC Cancer 2011, 11:494 http://www.biomedcentral.com/1471-2407/11/494 Page 6 of 10 Table 1 Checklist of fast track and conventional perioperative operation treatments (Continued) - Intravenous fluid infusion - Energy - Nasogastric tube and urethral catheter - Ambulation Adjuvant chemotherapy - Xelox - Stop intravenous high energy fluid infusion after dosage of Enteral Nutritional Emulsion Supportan ≥ 600 ml or Enteral Nutritional Emulsion Fresubin Diabetes ≥ 500 ml - No intravenous High-energy Nutrient Fluid after 72 h post-surgery - Restricting and avoiding excessive intravenous fluid infusion, keeping body weight as pre-surgery - Keep the total energy intake (both diet and intravenous fluid infusion) 25-30 kcal/kg/day -Remove nasogastric tube as soon as the end of operation - Remove urethral catheter within 24-48 h after operation - Forced ambulation within 24 h post-surgery, no time restriction - Ambulation time ≥ 1 h per day, and increasing day by day - Patients walking to weight themselves every day - repeat every 3 weeks for 8 cycles - Regimen Oxaliplatin 130 mg/m2 day 1, Capecitabine (Xeloda™) 850-1,000 mg/m2 twice daily for 14 days - - No peripherally inserted central catheter (PICC) - Intravenous high energy fluid infusion on daily basis and continuing until adequate oral intake - Keep the total energy intake (both diet and intravenous fluid infusion) 25- 30 kcal/kg/day - Remove nasogastric tube after 1st flatus postoperation -Remove urethral catheter when 1st time meet: patient have the feeling of automatic micturition and ≧200 ml after valving-on urethral catheter - No ambulation scheme - mFolfox6 - Regimen - repeat every 2 weeks for 12 cycles Oxaliplatin (EloxatinTM) 85 mg/m2 IV over 2 hours, day .1 Leucovorin (Tongao™) 400 mg/m2 IV over 2 hours, day 1. 5-FU (Jinyao™) 400 mg/m2 IV bolus on day 1, then 1,200 mg/m2/day × 2 days (total 2,400 mg/m2 over 46-48 hours) continuous infusion - Peripherally inserted central catheter and care of PICC in outpatient clinic every week - Hospitalization no more than 24 h each cycle - Hospitalization for 3 days each cycle Adjuvant chemotherapy In this study, adjuvant che- motherapy for III stage or high-risk II stage pathologi- cally established colorectal cancer includes Xelox and mFolfox6, both of regimens which in accordance with NCCN Clinical Practice Guidelines in Oncology ™ Colon Cancer V.2.2009. (a) mFolfox6 (repeat every 2 weeks for 12 cycles) Oxaliplatin (Eloxatin™, Sanofi-aventis, Hangzhou, CN) 85 mg/m2 IV over 2 hours, day 1 Leucovorin (Tongao™, Hengrui medicine Co., Ltd, Lian Yuan-gang, CN) 400 mg/m2 IV over 2 hours, day 1 5-FU (Jinyao™, Tianjin KingYork Amino Acid Co., Ltd. Tianjin, CN) 400 mg/m2 IV bolus on day 1, then 1,200 mg/m2/day × 2 days (total 2,400 mg/m2 over 46-48 hours) continuous infusion (b) Xelox, also known as CapeOX (repeat every 3 weeks for 8 cycles) Oxaliplatin 130 mg/m2 day 1, Capecitabine (Xeloda™, Roche, Shanghai, CN) 850-1,000 mg/m2 twice daily for 14 days Patient pathway All the patients in the FTMDT trial will go through as depicted in the flowchart (Figure 1) Statistical analysis Sample size calculation Hospital stay is the primary endpoint. From the evi- dence in the researches [13,14,22-26], we estimate the hospital stay of laparoscopic and open surgery with Fast-track perioperative treatment is 6 and 8 days. Xelox chemotherapy has at most 1 hospitalization day for each cycle followed by taking Capecitabine orally at home, for a total of 8 cycles. Therefore, we calcu- late the hospital stay for groups I and II at 14 and 16