Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group.The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer.ClinicalTrials.gov: NCT01080547Achieving a better quality of life for patients through enhanced recovery and shorter hospital stays in colorectal cancer treatment is becoming increasingly important.Compared with open surgery, laparoscopy-assisted surgery has been proved by consistent evidence as a safe and effective method of colorectal cancer treatment. It also has demonstrated the benefits in reduction of surgical injury and the improvement of short-term recovery outcome [1-4].Fast-track perioperative treatment, which is also referred as Enhanced Recovery after Surgery (ERAS), attracted much attention since Henrik Kehlet initially raised this concept [5]. This evidence-based fast-track perioperative treatment has been used for nearly a decade. The principle of the Fast-track treatment is to gain faster and enhanced recovery after surgery, by reducing unnecessary interventions which were formally involved in perioperative treatment, like reducing the fasting periods and bed