AIMS - The primary aim of this study is to determine whether laparoscopic-assisted resection is non-inferiorto open rectal resection as a safe, effective oncologic approach to rectal cancer. Secondary aims assessingmorbidity, mortality associated with surgery, disease-free survival, disease recurrence, quality of life, MRIstaging accuracy and an assessment of cost-effectiveness.BACKGROUND - Rectal cancer is a major public health concern, particularly in countries such as Australiaand New Zealand where the incidence is amongst the highest in the world.Surgical resection is the most important treatment for rectal cancer not only in terms of offering a possiblecure and best prognosis but in terms of treatment options that are available following surgery.There is growing use of laparoscopic surgery for rectal cancer in Australia over recent years, but withoutreliable evidence of its safety, efficacy and long-term effectiveness when compared with open surgery. Whilethere are potential advantages of laparoscopic surgery in terms of less time in hospital, smaller scars andless post-operative morbidity, these advantages are less established for the treatment of rectal cancer.Before laparoscopic procedures become recommended as standard, it is essential that reliable evidence isobtained that shows laparoscopic surgery is at least equivalent to open surgery in terms of pathologicalresults, patient-rated and long-term clinical outcomes.Studies have shown that surgical technique and the adequacy of resection predicts local recurrence rates inopen rectal surgery and the quality of surgical technique and resection should be as relevant in laparoscopicrectal resection. Recently published results support non-inferior short term outcomes in open andlaparoscopic-assisted surgical resections for colon cancer with regards to the quality of the resection andrecurrence rates. Similar findings may be revealed in rectal cancer, but technique, oncologic outcomes andrecurrence patterns must first be systematically evaluated.STUDY DESIGN - This is a multicentre randomised phase III trial. The study requires 470 patients to berandomised to either open laparotomy and rectal resection or laparoscopic-assisted rectal resection.STUDY PROGRESS - A pilot study opened in March 2010 supported by a grant from CSSANZ ResearchFoundation and additional funds from the AGITG and the NHMRC CTC. A 4-year NHMRC Project Grantcommenced in 2011 and a second NHMRC grant application will be submitted in 2014.A La CaRT has opened at 22 sites in Australia and New Zealand and 273/470 patients have beenrandomised. A further three sites will open in late 2013.www.agitg.org.au Page | 33To participate in A La CaRT surgeons must obtain accreditation by the A La CaRT Surgical AccreditationCommittee with an assessment based on relevant surgical experience. Currently 25 surgeons areaccredited and an additional five surgeons are expected to join the study.Translational research - Patients are invited at the time of study entry to provide written informed consentfor donation of a tissue (FFPE) sample for use in as yet undefined biological / translational sub-studies.