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.

Intraluminal bypass devices as an alternative to protective ostomy for prevention of colorectal anastomotic leakage: a systematic review of the literature

“…Colovac is the most recent bypass device; it was developed by Khosrovani et al . [41] This device consists of a flexible sheath covering the anastomosis, and a stent delimiting a vacuum chamber for anchoring the device to the colonic mucosa (Fig. 4b).…”

“…Khosrovani et al . [41] only recently introduced Colovac in a preclinical animal experiment with 22 pigs that had a colorectal anastomosis. The device was removed endoscopically at day 14, after which an open surgical exploration was performed to look for signs of AL.…”

“…They are inserted transanally with an introducer and anchored proximal to the anastomosis under direct visual guidance. Colovac even uses a self‐deploying system, further limiting procedural time [41]. In their recent pilot study on Cologuard, Reshef et al .…”

“…They are inserted transanally with an introducer and anchored proximal to the anastomosis under direct visual guidance. Colovac even uses a self-deploying system, further limiting procedural time [41]. In their recent pilot study on Cologuard, Reshef et al [40] reported no major device-related complications or problems with the connecting tube that sticks out of the abdominal wall.…”

“…However, the connecting tube is not practical for the patient and can be prone to infection. Stent migration appears to be the main challenge for Colovac, although the initial results were promising [41,42].…”