Charam Khosrovani, MD1, Anne Osdoit2, Gerard Hascouet, CEO3. 1Clinique Fontvert, Sorgues 84700, France, 2SAFEHEAL and MD START, Paris, France, 3MD START, Paris France
Introduction: Anastomotic leak is one of the most challenging complications of colorectal surgery with a 30% post-operative death, reduced quality of life and negative outcome in cancer patients. Temporary diverting ostomy is recommended to reduce the risk of anastomotic adverse events. However, ostomies are debilitating for patients, prone to complications, costly and inefficient in terms of patient management. Colovac is a novel intracolonic temporary bypass device which alleviates the need for ostomies while protecting colorectal anastomoses. It consists of a flexible sheath attached to an internally covered braided nitinol stent. The device is anchored through a combination of the radial force provided by the stent, and of a vacuum pulled in the volume, essentially “sucking” the colonic wall against the device. The aim of this study was to evaluate safety, time to migration and anastomotic healing using Colovac in pig models.
Methods: Eleven female pigs were allocated between a Colovac group (6 animals) or a control group (5 animals). The left colon was washed out by saline mixed to povidone iodine. Adnexectomy was performed through midline laparotomy in order to avoid adnexa to interfere with the anastomotic healing. A highly imperfect manual colorectal anastomosis was performed using 3 equidistant sutures leaving large gaps to facilitate faecal leak. In Colovac group the device was inserted endoluminally through the external anal orifice, about 10 cm proximal to the anastomosis thanks to a dedicated introducer. The sheath and the vacuum tube were deployed distally through the anastomosis and then through the anal orifice to avoid contact with the faecal bowl. The vacuum tube was connected to a Redon vial, providing constant aspiration during the implantation period. At day 14, an en bloc excision of the left colon and colorectal anastomosis was performed and the resected specimens were sent for histopathological examination.
Results: All Colovac deliveries and deployments were technically successful with no adverse event nor difficulty noted during the initial surgery. One animal died in the Colovac group due to mesenteric ischemia which was not related to the device. The average time to migration of Colovac was 9.4 (SD ±2.5) days (table 1). None of the Colovac group animals had anastomotic stenosis, in addition the fibrotic reaction was moderate. The colonic mucosa in contact with the stent was erosive except in one animal with mucosal ulceration. All the control animals had high grade stenotic anastomosis sustained by extensive fibrotic reaction.
Conclusions: Colovac is safe and seems to promote healing of highly imperfect colorectal anastomosis in a porcine model. A safety clinical trial is scheduled in 2017.
Table 1- Postoperative Colovac migration
Animals Time to migration (days)
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 83932
Program Number: ET001
Presentation Session: Emerging Technology Session
Presentation Type: Podium