Safety and Efficacy of the NiTi Shape Memory Compression Anastomosis Ring (CAR/ColonRing) for End-to-End Compression Anastomosis in Anterior Resection or Low Anterior Resection

摘要

PURPOSE: Compression anastomoses may represent an improvement over traditional hand-sewn or stapled techniques. This prospective exploratory study aimed to assess the efficacy and complication rates in patients undergoing anterior resection (AR) or low anterior resection (LAR) anastomosed with a novel end-to-end compression anastomosis ring, the ColonRing. METHODS: In all, 20 patients (13 male) undergoing AR or LAR were enrolled to be anastomosed using the NiTi Shape Memory End-to-End Compression Anastomosis Ring (NiTi Medical Technologies Ltd, Netanya, Israel). Demographic, intraoperative, and postoperative data were collected. RESULTS: Patients underwent AR (11/20) or LAR using laparoscopy (75%), robotic (10%) surgery, or an open laparotomy (15%) approach, with a median anastomotic level of 14.5 cm (range, 4-25 cm). Defunctioning loop ileostomies were formed in 6 patients for low anastomoses. Surgeons rated the ColonRing device as either easy or very easy to use. One patient developed an anastomotic leakage in the early postoperative period; there were no late postoperative complications. Mean time to passage of first flatus and commencement of oral fluids was 2.5 days and 3.2 days, respectively. Average hospital stay was 12.6 days (range, 8-23 days). Finally, the device was expelled on average 15.3 days postoperatively without difficulty. CONCLUSIONS: This is the first study reporting results in a significant number of LAR patients and the first reported experience from South Korea; it shows that the compression technique is surgically feasible, easy to use, and without significant complication rates. A large randomized controlled trial is warranted to investigate the benefits of the ColonRing over traditional stapling techniques.