Results of anastomotic leak after low Anterior resection with or without preventive stoma for rectal cancer in low-risk patients in nonemergency departments (RELOAD): final protocol of multicenter randomized controlled non-inferiority trial

Introduction. Anastomotic leakage (AL) following low anterior resection (LAR) for rectal cancer is a major complication. Preventive stoma formation reduces the risk of AL. However, it is associated with lower quality of life, reversal surgery, stoma-related complications and prolonged overall treatment. Routine stoma formation does not appear to confer clear benefits in low-risk patients. The aim of this study is to compare the safety outcomes of LAR with and without a preventive stoma in patients with a low initial risk of AL. Methods. This multicenter randomized non-inferiority trial will enroll patients classified as low-risk for AL (predicted risk ≤ 10 %) undergoing laparoscopic TME for rectal cancer. In the experimental group, preventive ileostomy or colostomy will not be performed. In the control group – standard practice. The primary endpoint will be the incidence of colorectal anastomotic leak. Discussion. The problem of preventive stoma is not solved in low predicted risk population. New evidence is needed to determine whether routine stoma formation can be safely omitted in these patients. Ongoing trials, including GRECCAR 17 and the SELSA trial, address related questions but have defined different primary endpoints. The present study focuses on the most clinically relevant and objective outcome – rate anastomotic leak. The results will help to support individualized surgical decision-making and improve the quality of life.