A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer
The design involves allocation of all suitable consecutive patients with colon carcinoma to
either of the two procedures at a randomization ratio of 1:1. The trial will be stratified
according to participating centre, resection type and gender.
Disease free survival for all TNM stages after 3 years is currently about 70%. To detect a
difference of 7% in disease free survival rate after 3 years between open and laparoscopic
resection of colon cancer, 1200 patients will have to be included (60 vs 67%, two-sided
analysis; alfa=0.05, beta=0.20, power=80% and p=0.05). All analyses will be performed on an
intention to treat basis.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary endpoint is cancer free survival at three years.
Jaap Bonjer, MD, PhD
Dalhousie University, CDHA / Erasmus MC Rotterdam
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)