Safety and Performance of the Colovac Anastomosis Protection Device. A Pooled Analysis of Prospective Studies Compared With Diverting Loop Ileostomy (SAFE-2025).

OBJECTIVE: To compare the safety and effectiveness of the Colovac Anastomosis Protection Device with standard diverting ostomy (DO) following low anterior resection (LAR) for rectal cancer. SUMMARY BACKGROUND DATA: DO is standard of care (SOC) following LAR for rectal cancer but is associated with substantial morbidity. Colovac Device is designed to divert the fecal stream away from the anastomosis intraluminally. METHODS: Three prospective multicenter Colovac trials were pooled and compared with a prospective cohort of patients undergoing LAR with DO for rectal cancer using a propensity score-weighted approach to balance baseline characteristics. The primary safety endpoint for both Colovac and SOC trials was the rate of device-related or stoma-related early major complications by POD10. Secondary endpoints included early anastomotic leak (AL) rates, fecal stream diversion effectiveness, and device migration. RESULTS: Patients were included (Colovac=49, DO=54). By POD10, device- or stoma-related major complications rates were 4.1% (2/49) vs 5.6% (3/54) (P=0.167). All Colovac devices were successfully placed and retrieved with stoma avoidance achieved in 83.7% at POD10. Major complication rates were similar between groups. Rates of AL detected on POD9/10 were comparable between Colovac and control patients (28.6% vs. 20.4%, P=0.102), with total AL rate of 32.6% in Colovac versus 27.8% (P=0.342) in control at POD30. Effective fecal diversion was achieved in 91.7% of Colovac patients, with device migration in 14.3%. CONCLUSIONS: Colovac enabled ostomy avoidance in most patients without increasing major complications or AL, suggesting its role as a potential alternative to DO following LAR for rectal cancer. TRIAL REGISTRATION: SAFE-2019: NCT05180565; SAFE-2: NCT05010850; SAFE-2023: NCT06540807; SH-SOC23: NCT06152276.