ROLARR: robotic versus laparoscopic resection for rectal cancer: P008

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Aim:Robotic-assisted rectal cancer resection is gaining popularity, although the benefits and costeffectiveness remain unclear. A rigorous evaluation is required by means of a randomised controlled trial to determine safety, efficacy, and cost-effectiveness of robotic-assisted surgery for the curative treatment of rectal cancer.Method:An international, multicentre,prospective, randomised controlled, unblinded, parallelgroup superiority trial of robotic-assisted versus laparoscopic surgery. Inclusion criteria include rectal adenocarcinoma suitable for curative resection by anterior resection or abdominoperineal excision. Exclusion criteria include locally advanced cancers requiring multi-visceral resection, synchronous and anal canal cancers, inflammatory bowel disease, and invasive cancer within 5-years. Theprimary endpoint is conversion to open surgery. Two key secondary end-points include the pathological CRM positivity rate and the 3-year local recurrence rate. Other secondary end-points include 30-day morbidity and mortality, bladder and sexual function, health-related QoL, 3-year disease-free and overall survival, and cost-effectiveness. Four hundred patients (200 in each arm) will be recruited to detect a 50% difference in conversion rates at 80% power and 5% significance. The trial will launch in September 2010, with 18 months recruitment and 3-year follow-up. The trial is jointly funded by the UK-MRC/EME and NIHR.

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