COLOR IV: a multicenter randomized clinical trial comparing intracorporeal and extracorporeal ileocolic anastomosis after laparoscopic right colectomy for colon cancer.

INTRODUCTION

Right-sided colon cancer is a prevalent malignancy. The standard surgical treatment for this condition is laparoscopic right hemicolectomy, with ileocolic anastomosis being a crucial step in the procedure. Recently, intracorporeal ileocolic anastomosis has garnered attention for its minimally invasive benefits. However, there remains a paucity of rigorously designed, large-scale, international multicenter randomized controlled trials to definitively assess the safety and efficacy of intracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy for right-sided colon cancer.

METHODS

This study is an international, multicenter, randomized, controlled, open-label, non-inferiority trial designed to compare the safety and efficacy of intracorporeal versus extracorporeal ileocolic anastomosis in patients with right-sided colon cancer undergoing right hemicolectomy. The primary endpoint is the anastomotic leakage rate within 30 days post-surgery. The main secondary endpoint is the 3-year disease-free survival rate post-surgery. A comprehensive quality assurance protocol will be established before the trial begins, including CT review, pathological evaluation, and the standardization and assessment of surgical techniques.

DISCUSSION

This study aims to evaluate the safety and efficacy of intracorporeal ileocolic anastomosis following right hemicolectomy in patients with right-sided colon cancer. The anticipated outcome is that intracorporeal ileocolic anastomosis will show an anastomotic leakage rate and a 3-year disease-free survival rate comparable to those of extracorporeal anastomosis, while offering the added benefit of faster postoperative recovery.