Charam Khosrovani, MD. Clinique Fonvert
Aims: Anastomotic leakage (AL) and its complication remain the main concern following colorectal surgery. A defunctioning ostomy is commonly used to protect patients but is fraught with its own complications. This study examined the feasibility, safety, usefulness of Colovac, an anastomosis protection device, alleviating the need for ostomies. Colovac consists of a flexible bypass sheath placed in the colon lumen and intended to prevent extravasation of intracolonic content in case of dehiscence. The sheath is anchored using a stent and a vacuum system, sucking the colonic wall against the device.
Methods: Between 2016 and 2017, 22 12-week-old female pigs underwent low-anterior resection and circular-double-stapled anastomosis in an end-to-end technique. Once the anastomosis was created, Colovac was inserted endoluminally through the anus and the stent delivered and expanded 10 cm proximal to the anastomosis using a dedicated introducer. The sheath and vacuum-tube were deployed distally through the anastomosis and the anal orifice, with the vacuum-tube connected to a Redon vial, providing constant aspiration during the implantation period. All animals were sacrificed on a maximum of 14th-day post-surgery, after endoscopic removal of the device if no prior natural expulsion occurred. The anastomotic and stent implantation regions were examined for signs of abnormalities or impaired healing by histology.
Results: Surgical implantation of Colovac was technically successful in all cases, with immediate stent deployment and effective aspiration, requiring no more than 5-minutes additional time. During the implantation period, none of the animals died nor developed clinically relevant disease due to AL or intra-abdominal infection. One animal died of ischemia unrelated to the Colovac. Migration occurred in the 7 first animals, leading to a natural expulsion between D+3 and D+11. Absence of migration was achieved for 13 of the 14 following animals by reinforcing the connection of the aspiration tube and implementing a low-residue-diet during the entire implantation period. One animal had premature migration of the device due to an inadvertent disconnection of the vacuum system. Endoscopic retrieval was achieved in all cases. Macroscopic examination of the abdominal cavity showed no AL, intra-abdominal abscess, fistulas, nor necrosis. Microscopic examination showed signs of inflammation at the stent implantation site without abscess nor infection. All anastomotic lines appeared normal.
Conclusion: This study indicates an easy, safe use of Colovac in animals. Feasibility was achieved for insertion and removal. Anastomotic complications were absent. Preliminary efficacy is encouraging, arguing for a careful clinical evaluation in humans currently under preparation.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 86217
Program Number: S057
Presentation Session: Instrumentation / Devices / Technologies Session
Presentation Type: Podium
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