Assessment of a Vacuum-Based Intra-Colonic Diverting Device: A Preclinical Study.

ABSTRACT

Purpose. Anastomotic leak is the main complication after low colorectal anastomosis. Defunctioning ileostomy is therefore recommended, which carries its own morbidity. The aim of this study was to assess the technical feasibility, safety, and preliminary efficacy of a vacuum-based intra-colonic diverting device (Colovac) to reduce the impact of anastomotic leak. Methods. This prospective preclinical study was conducted on living swine. The device was surgically inserted transanally, proximal to a colorectal anastomosis, and removed endoscopically at day 14. Then, open surgery was performed to look for deep sepsis and/or anastomotic leak, and the remaining colorectal anastomosis was resected for histopathological analysis. The endpoints were successful insertion and delivery of the device, postoperative morbidity, successful maintaining of the device, and absence of feces spillage and/or abscess in the abdominal cavity. Results. The Colovac was inserted in 22 swine. Stent migration occurred in 7 of the first 8 specimens, leading to natural expulsion of the device. After diet adaptation, a subsequent group of 14 swine was undertaken, of which 13 did not show any sign of migration post-implantation. Disconnection of the suction drain occurred in 1 case, leading to device expulsion on day 10. Colovac retrieval was achieved successfully in 13 cases. The endoscopic assessment of the anchorage site showed limited mucosal injury, whereas histopathological findings revealed mild hyperplasia. One swine died prematurely of postoperative colonic ischemia. Conclusion. This new device appears to be safe in the swine model and may prevent peritonitis or abscess due to colorectal anastomotic leak.