SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE‐2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device
Elisabeth Hain,
Jérémie H. Lefèvre,
Alison Ricardo
et al.
Abstract:AimAlthough proximal faecal diversion is standard of care to protect patients with high‐risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE‐1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence … Show more
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