Australian and New Zealand study comparing laparoscopic and open surgeries for colon cancer in adults: organization and conduct.

This article describes the initiation and implementation of the multicentre Australia and New Zealand prospective randomized controlled clinical study comparing laparoscopic and conventional open surgical treatments of right-sided and left-sided potentially curable colon cancer (Australasian Laparoscopic Colon Cancer Study). Six hundred and one adult patients were admitted with a clinical diagnosis of a single adenocarcinoma based on a physical examination and colonoscopy, barium enema or computed tomography scan and randomly allocated to either laparoscopic or open surgery. The primary aim of the study is to compare 5-year mortality and tumour recurrence rates between the two groups. Secondary aims include comparisons of safety (intraoperative and early postoperative complications, wound site recurrence, postoperative recovery and 30-day mortality), quality of life, in-hospital costs and short-term mortality and tumour recurrence. The data for 592 patients have been collected. There are currently 3141 person years of follow up. In all 370 patients have been assessed at 5 years. This study shows that large cooperative Australia-New Zealand surgical trials can and should be carried out to address significant clinical issues. When possible, coherence with similar, concurrent international trial protocols ensures broader analyses and applicability of results. It is important to recognize that special attention to sustained funding, surgeon credentialing, clinical protocol standardization, data management, publication policy and the protection of study credibility is required from the outset. The Australasian Laparoscopic Colon Cancer Study will achieve its aims with 5-year assessments of all entered patients in March 2010.