Evaluation of the SafeHeal Colovac+ Anastomosis Protection Device: A Preclinical Study

Abstract

Background The protective ostomy is the current standard of care to protect a low colorectal anastomosis from leakage, but exposes patients to complications requiring an alternative strategy. The Colovac+ is a vacuum-based intraluminal bypass device designed to shield the anastomosis from fecal content, preventing the clinical outcomes of anastomotic leakage. The objective of this study was to evaluate the preliminary efficacy, safety, and technical feasibility of the Colovac+ in a porcine model. Methods: Twelve pigs received a colorectal anastomosis with Colovac+ implantation. The device was left in situ for 10 days and then retrieved endoscopically. Six pigs were to be sacrificed immediately after device retrieval and the other 6 were to be sacrificed on day 38. Clinical, endoscopic, and histopathological examinations were performed to evaluate the following endpoints: prevention of contact between the anastomosis and fecal content, device migration, feasibility of the implantation and retrieval procedure, collateral damage to the colonic wall, colon healing after device retrieval, and systemic toxicity related to the device. Results: Eleven pigs completed the study. One pig died prematurely due to a surgical complication unrelated to the device (bladder damage with uroperitoneum). There was no evidence of contact between the anastomosis and fecal content, none of the pigs developed symptomatic anastomotic leakage, there were no significant device migrations, and there was no evidence of systemic toxicity. Colovac+ implantation was easily performed in all cases except 1 (due to an inappropriate lubricant). Colovac+ retrieval was achieved successfully in all cases. Postretrieval examinations on day 10 revealed ulcerations at the anchoring site in 4 cases indicating mechanical damage caused by the stent. However, in the recovery group, no ulcerations were observed on day 38, and the colonic wall had properly healed in all animals. Conclusions: The Colovac+ is a technically feasible, safe, and efficient device for the protection of a colorectal anastomosis in a porcine model. The device holds promise for clinical use and warrants further research.

Clinical using of innovative Biodegradable Stent with Extension Sleeve in TaTME for Low Rectal Cancer with high risk of anastomotic leakage

“…In response to these issues, many scholars have innovated various techniques to reduce complications like anastomotic stula and stricture, such as Cai's intestinal diversion stent, the sac rectal drainage tube, the condom connection method for intestinal bypass, and the sheathed ileostomy technique [25][26][27][28][29][30]. However, these have not been reported for use in Ta_tme surgery.…”

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

“…The CD is a sterile, single‐use, temporary intraluminal faecal bypass device composed of one introducer pre‐loaded with the CD (Figure 1) [28]. The CD includes two components (Figure 1): an anchor consisting of a 100‐mm length covered double stent delimiting a vacuum chamber connected to two vacuum tubes; a flexible 600‐mm length sheath attached to the anchor covering the anastomosis.…”

“…The CD is a sterile, single-use, temporary intraluminal faecal bypass device composed of one introducer pre-loaded with the CD (Figure 1) [28]. The CD includes two components (Figure 1):…”