A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
The design involves allocation of all suitable consecutive patients with rectal carcinoma to
either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic
procedure. Excluded are patients with a carcinoma treated by local resection and palliative
resections. The trial will be stratified according to participating centre, resection type,
and preoperative radiotherapy.
If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a
difference greater than 5% in favor of the conventional procedure, non-inferiority of the
laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases
are required in total for a power of 80%.
Analysis will be primarily on an intention to treat basis. Definition of conversion is
defined by protocol.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
locoregional recurrence rate
3 years post operatively
Jaap Bonjer, MD, PhD
Dalhousie University, CDHA and VUMC, the Netherlands
Canada: Health Canada