D'Hoore A, Hompes D, Folkesson J, Penninckx F, PAhlman L
Department of Abdominal Surgery, University Hospital Gasthuisberg Leuven, Leuven, Belgium.
Minim Invasive Ther Allied Technol. 2008;17(3):172-5. doi: 10.1080/13645700802103142.
The recent development of a compression device using shape memory Nitinol technology to create an end-to-end anastomosis has renewed the interest in sutureless anastomotic techniques. A phase II, prospective open label clinical trial was started in May 2007 to evaluate the feasibility and safety of this new anastomotic device. Fourty patients who need left colectomy or high anterior resection for either diverticular disease or adenocarcinoma will be recruited in two academic hospitals (Uppsala,Sweden and Leuven, Belgium). Clinical leakage is the primary endpoint. Only preliminary results are available to date as the recruitment is ongoing. The median age of the first ten patients is 57.5 years (44-72). No anastomotic leakage occurred. The median hospital stay was 4.0 days. Only three patients noticed the passage of the ring through the anal canal. By three weeks no ring was sustained in the gastrointestinal tract as was objectified by plain X-ray. First clinical use of this new anastomotic device seems promising. Final results for the total phase II trial are awaited. A prospective randomized trial to compare the efficacy of the EndoCar 28 with conventional stapling should be the next step.
最近，一种采用形状记忆镍钛诺技术制造的用于进行端端吻合术的压缩装置的研发，重新引发了人们对无缝合吻合技术的兴趣。2007年5月启动了一项II期前瞻性开放标签临床试验，以评估这种新型吻合装置的可行性和安全性。两家学术医院（瑞典乌普萨拉和比利时鲁汶）将招募40名因憩室病或腺癌需要进行左半结肠切除术或高位前切除术的患者。临床渗漏是主要终点。由于招募工作仍在进行中，目前仅有初步结果。前十位患者的中位年龄为57.5岁（44 - 72岁）。未发生吻合口漏。中位住院时间为4.0天。只有三名患者注意到环通过肛管。到三周时，通过普通X光检查证实胃肠道中没有环留存。这种新型吻合装置的首次临床应用似乎很有前景。正在等待II期试验的最终结果。下一步应该是进行一项前瞻性随机试验，比较EndoCar 28与传统吻合器的疗效。
