Comparative results of performing low anterior rectal resection without the formation of a preventive stoma and with the formation of a preventive transverse ostomy and/or ileostomy in a routine ward: protocol for a multicenter randomized controlled trial

Introduction. Anastomotic leak after low anterior resection (LAR) is a life-threatening complication. Preventive stoma formation is the primary method of prevention, but is associated with decreased quality of life and the need for reoperation. Objective: To compare the outcomes of LAR with total mesorectumectomy (TME) with and without a preventive stoma in patients with a low initial risk of leakage. Materials and methods. This multicenter RCT included patients with rectal cancer who underwent laparoscopic LAR with TME at a low risk of leakage. The study group consisted of patients without stoma formation, while the control group consisted of patients with similar characteristics but with a preventive ileostomy or transverse ileostomy. Discussion. The advisability of a stoma in low-risk patients remains unresolved. A protocol for a multicenter RCT, the RELOAD-trial, was developed to investigate this issue. Conclusion. The results will show the incidence of leaks, immediate outcomes, quality of life, and the incidence of ileostomy syndrome in the compared groups.