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

P. SyllaDepartment of Surgery, Division of Colon and Rectal Surgery, Icahn School of Medicine at Mount Sinai, New York, NYKatherine LamDepartment of Surgery, Division of Colon and Rectal Surgery, Icahn School of Medicine at Mount Sinai, New York, NYNiels KomenUniversitair Ziekenhuis Antwerpen, BelgiumJean-Jacques TuechDepartment of Digestive Surgery, Rouen University Hospital, Rouen, FranceAntonio SpinelliDivision of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, ItalyJoseph MartzDivision of Colon and Rectal Surgery, Lenox Hill Hospital, New York, NYRebecca RheeDepartment of Surgery, Maimonides Medical Center, Brooklyn, NYJorge MarcetDivision of Colon and Rectal Surgery, University of South Florida, Tampa, FLGuy Bernard CadièreDigestive Surgery, Hôpital Universitaire St Pierre, ULB, Brussels, BelgiumPhilippe RouanetDepartment of Colorectal Surgery, Institut du Cancer de Montpellier, Montpellier, FranceA. M. KarachunN. N. Petrov National Medical Research Centre of Oncology, St Petersburg, RussiaQuentin DenostNarkhodzha SametdinovAkfa Medline, Tashkent, UzbekistanAndre D’HooreDepartment of Abdominal Surgery, University Hospitals Leuven, Leuven, BelgiumSang LeeDivision of Colon and Rectal Surgery, University of Southern California, Los Angeles, CAJérémie H. LefèvreAssistance Publique – Hôpitaux de Paris

2026en

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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.

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DOI: 10.1097/sla.0000000000007171

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