Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
I. To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal
cancer resection by means of a randomized, controlled trial.
II. To assess technical ease of the operation, as determined by the clinical indicator of
low conversion rate to open operation.
III. To assess surgical accuracy and improved oncological outcome as determined by clear
pathological resection margins.
IV. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge
to inform NHS and other service providers and decision-makers.
V. To analyze disease-free and overall survival and local recurrence rates at 3-year
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard laparoscopic resection.
ARM II: Patients undergo robotic-assisted laparoscopic resection.
After completion of study treatment, patients are followed up at 1 month, 6 months, and then
annually thereafter for 3 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of conversion to open surgery as an indicator of surgical technical difficulty
At completion of surgery
Beckman Research Institute
United States: Institutional Review Board