Zhou et al. BMC Cancer 2011, 11:494 http://www.biomedcentral.com/1471-2407/11/494 Anesthesiologists (ASA) score ≥ IV, mid-low rectal can- cer, and pregnant woman. Adjuvant chemotherapy will be needed for III stage or high-risk II stage pathologically established colorectal can- cer. The performance status of the patients after surgery will be evaluated with the Zubrod-ECOG-WHO score, before the chemotherapy start. Patients with Zubrod- ECOG-WHO score sustain ≥ 2 within 3 months after sur- gery will be excluded and not have the chemotherapy. Discontinuance criterion The discontinuance criterion of this clinical trial as fol- lowings: 1) the trial appears causing unexpected harm or severe adverse events to participants, or the evidence that the risks outweigh the benefits, with the discontinu- ance decision of the ethics committees. 2) the enroll- ment indicates the trial can’t be finished in the period of 4 years. 3) chemotherapy will be suspended for the patients with the chemotherapy adverse events more than grade 3 according to NCI-CTC AE 3.0 (National Cancer Institute Common Terminology, Criteria for Adverse Events 3.0). And the dose will be adjusted to 75% after adverse events reduce to grade 2 or lower. The chemotherapy will be withdrawn once the severe adverse events appear again. Primary and secondary endpoint measures The primary outcome measure of this FTMDT-trial is the hospital stays, which is the overall hospitalization stay during treatment including both the hospital stay for the surgery and adjuvant chemotherapy. We define the postoperative discharge day for the patients in the trial when they meet all of the discharge criteria, 1. Good pain control: NSR (Numeric Rating Scale) ≤ 3. 2. Tolerance of solid food, no need of intra- venous fluid infusion. 3. Independent activities of daily living (ADL) to preoperative care level at least [18,19]. Secondary outcome measures are as follows, 1. Quality of life according to EORTC (European Organization for Research and Treatment) QLQ-C30 and QLQ-CR38 questionnaires, with the checkpoint frame, preoperation, 1 week post operation, 3-months post surgery and 6- months post surgery. 2. Chemotherapy related adverse events according to NCI CTCAE (Common Terminol- ogy Criteria for Adverse Events) Version3.0. 3. Surgical complications mainly include injury of the ureters, intraoperative transfusion, infection of incision, anasto- motic leakage and readmission. 4. Hospitalization costs are calculated from the first day in hospital to the last day that adjuvant chemotherapy is finished. Participating centers The FTMDT-trial is a multi-center study located in China, with 3 participating centers as follows, Hangzhou Page 3 of 10 center (Department of Surgical Oncology, Second Affiliated Hospital, Zhejiang University College of Medi- cine), Shaoxing center (Department of Anorectum, Peo- ple’s Hospital of Shaoxing), Wenzhou center (Department of Anus and Large Intestine, Second Affiliated Hospital, Wenzhou Medicine College). Ethics The independent medical ethics committees of the par- ticipating hospitals have approved this FTMDT-trial protocol, with the approval number: 2010LSY No.6. All the procedures of this study are under the oversight of the Chinese Ministry of Health. Study outline Interventions Surgery Much experience has been accumulated since the first laparoscopic colectomy in 2003 in Hangzhou center, as the number of all colorectal cancer surgery has been approximately up to 350 per year, including about 30% open surgery and 60% laparoscopic surgery. Shaoxing center has done approximately 400 laparo- scopic colorectal surgeries since developed in 2004 and Wenzhou center approximately 300 since 2005. In this study, open and laparoscopic surgery will be per- formed according to the principles of NCCN Clinical Practice Guidelines in Oncology ™ Colon Cancer V.2.2009 and there are 8 colorectal surgeon specialists, all of whom are Attending Surgeons (Ke-Feng Ding, Xiao- Jiang Ying, Rong Chen, Yong-Mao Song, Jian-Wei Wang, Li-Feng Sun, Yong-Chuan Deng, Yi Shen). The former five of them are for laparoscopy and they have performed laparoscopic operations in colorectal cancer with a mini- mum of 20 as suggested by the ASCRS [20,21]. Perioperative treatment Patients in groups III and IV will receive conventional perioperative treatment, while patients in groups I and II will receive the fast track perioperative treatment, which will be provided by trained doctors and nurses separately. The essence of the fast track perioperative treatment can be represented from 3 periods, 1. Preoperation, psy- chological optimism and information of the fast track treatment to patients, less time fasting, oral carbohy- drate loaded liquids. 2. Intraoperation, combined anesthesia consisting of epidural and general anesthesia with the use of morphine minimized as far as possible, minimal use and early removal of nasogastric tube, drains and catheter, body warming as well as intrave- nous fluid warming. 3. Post operation: pain management without opioid, early feeding rehabilitation, restriction of intravenous fluid infusion, early ambulation. The comparison of fast track and conventional perio- perative operation treatments are summarized in Table 1.