A La CaRT: Australasian Laparoscopic Cancer of the Rectum Trial A phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer

This study compares surgery using a laparoscope (keyhole surgery) compared with open surgery in treating colorectal (bowel) cancer. You can join this study if you have been diagnosed with primary cancer of the rectum or lower bowel (stage T 1-3 N 0-1 M 0-1) that requires surgery. Trial participants will be randomly divided into two groups. One group will receive surgery using a laparoscope (keyhole surgery) while the other will receive the standard open surgery. Patients will be assessed 6 weeks prior to surgery, with follow up checks at day 3 and day 14 post surgery, and then at 4–6 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and annually at 3, 4 and 5 years. Surgical resection of the tumour is the most important treatment for rectal cancer. Laparoscopic-assisted techniques allow the tumour to be removed with smaller incisions, and less invasive surgery. This study aims to determine whether these new techniques offer a safe and viable alternative to standard surgery. The primary aim of this study will be to determine whether laparoscopic-assisted resection of rectal cancer is non-inferior (or equivalent) in safety and efficacy to the open technique of laparotomy and surgical resection. The secondary aim of the study will be to determine whether laparoscopic-assisted rectal resection is equivalent to open rectal resection in providing comparable recovery outcomes and in terms of disease recurrence and survival, and quality of life.