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. 2025 Feb;39(2):1182-1190.
doi: 10.1007/s00464-024-11412-7. Epub 2024 Dec 28.

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

Si Wu #  1 , Pengyu Wei #  1 , Jiale Gao #  1 , Wenlong Shu #  1 , Hanzheng Zhao #  1 , Hendrik Bonjer  2 , Jurriaan Tuynman  2 , Hongwei Yao  3 , Zhongtao Zhang  4 ; COLOR IV study group
Affiliations

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

Si Wu et al. Surg Endosc. 2025 Feb.

Abstract

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.

Keywords: Anastomotic leakage; Colon cancer; Intracorporeal ileocolic anastomosis; Laparoscopic.

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Conflict of interest statement

Declarations. Disclosures: Drs. Si Wu, Pengyu Wei, Jiale Gao, Wenlong Shu, Hanzheng Zhao, Hendrik J. Bonjer, Jurriaan A. Tuynman, Hongwei Yao, and Zhongtao Zhang have no conflicts of interest or financial ties to disclose.

Figures

Fig. 1
Fig. 1
Flowchart of the study design
Fig. 2
Fig. 2
Details of inclusion and exclusion criteria
Fig. 3
Fig. 3
The surgical procedure of anastomosis in the intervention arm (intracorporeal ileocolic anastomosis) and the control arm (extracorporeal ileocolic anastomosis): the terminal ileum and transverse colon are transected using a laparoscopic linear stapler and side-to-side anastomosis is mandatory in both arms
See this image and copyright information in PMC

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