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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

机译:NiTi形状记忆压缩吻合环(CAR / ColonRing)在前切除术或低位前切除术中端对端压缩吻合术的安全性和有效性

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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.
机译:目的。压缩吻合可以代表对传统手工缝制或装订技术的改进。这项前瞻性探索性研究旨在评估接受新型端到端加压吻合环ColonRing吻合的前切除术(AR)或低位前切除术(LAR)的患者的疗效和并发症发生率。方法。使用NiTi形状记忆端对端加压吻合环(以色列内坦亚的NiTi Medical Technologies Ltd),总共招募了20位接受AR或LAR的患者(13位男性)进行吻合。收集了人口统计学,术中和术后的数据。结果。患者接受腹腔镜检查(75%),机器人手术(10%)或开放式剖腹手术(15%)进行AR(11/20)或LAR,中位吻合水平为14.5厘米(范围4-25厘米) 。低吻合术在6例患者中形成功能失常的回肠切开术。外科医生对ColonRing设备的评价为容易或非常易于使用。一名患者在术后早期发生了吻合口漏;术后无晚期并发症。初次肠胃气胀和开始口服液体的平均时间分别为2.5天和3.2天。平均住院时间为12.6天(范围为8-23天)。最终,该装置在术后平均15.3天没有困难地被排出。结论这是第一项报道了大量LAR患者的研究结果,也是韩国首次报道的经验。它表明压缩技术在外科手术中可行,易于使用,并且没有明显的并发症发生率。有必要进行一项大型的随机对照试验,以研究ColonRing优于传统的吻合钉技术。

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