Recurrent Rectal Cancer Clinical Trial
Official title:
Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for
rectal cancer and may have fewer side effects and improve recovery. It is not yet known
whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in
treating patients with rectal cancer.
PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see
how well it works compared to laparoscopic surgery in treating patients with rectal cancer
that can be removed by surgery.
OBJECTIVES:
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
follow-up.
OUTLINE:
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
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