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.