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

Abstract

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. 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. 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. 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%. 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. SAFE-2019: NCT05180565; SAFE-2: NCT05010850; SAFE-2023: NCT06540807; SH-SOC23: NCT06152276.