Department of Clinical Sciences, Section of Surgery, Malmö, Lund University, Malmö, 205 02, Sweden.
Section of Development, CarpoNovum, Halmstad, 302 41, Sweden.
Int J Colorectal Dis. 2023 May 13;38(1):127. doi: 10.1007/s00384-023-04420-x.
C-REX is a novel instrument for creating stapleless colorectal anastomosis by compression. The aim of this study was to evaluate the feasibility and effectiveness of C-REX in open and laparoscopic high anterior resections.
A prospective clinical safety study on 21 patients reconstructed with C-REX colorectal anastomosis following high anterior resection of the sigmoid colon using two different devices for intraabdominal (n = 6) or transanal (n = 15) placement of the anastomotic rings. Any signs of complications were prospectively monitored by a predefined protocol. Anastomotic contact pressure (ACP) was measured via a catheter-based system, and time for evacuation of the anastomotic rings by the natural route was noted. Blood samples were collected daily, and flexible endoscopy was performed postoperatively to examine macroscopic appearance of the anastomoses.
One of six patients operated with the intraabdominal anastomosis technique with an ACP of 50 mBar had to be reoperated because of anastomotic leakage. None of the 15 patients operated with the transanal technique (5 open and 10 laparoscopic procedures) had anastomotic complications, and their ACP ranged between 145 and 300 mBar. C-REX rings were uneventfully expelled by the natural route in all patients after a median of 10 days. Flexible endoscopy showed well-healed anastomoses without stenosis in 17 patients and a moderate subclinical stricture in one patient.
These results indicate that the novel transanal C-REX device is a feasible and effective method for colorectal anastomosis following high anterior resections, irrespective of open or laparoscopic approach. Moreover, C-REX allows measurement of intraoperative ACP and thereby a quantitative evaluation of the anastomotic integrity.
C-REX 是一种通过压缩来制造无钉结结直肠吻合的新型器械。本研究旨在评估 C-REX 在开腹和腹腔镜高位前切除术应用于结直肠吻合的可行性和有效性。
前瞻性临床安全性研究,纳入 21 例接受乙状结肠高位前切除术后行 C-REX 结直肠吻合的患者,使用两种不同的设备进行腹腔内(n=6)或经肛门(n=15)放置吻合环。通过预设方案前瞻性监测任何并发症迹象。通过基于导管的系统测量吻合接触压力(ACP),并记录吻合环通过自然途径排出的时间。每天采集血液样本,并进行软性内镜检查以检查吻合口的宏观外观。
6 例采用腹腔内吻合技术(ACP 为 50 mBar)的患者中有 1 例因吻合口漏而不得不再次手术。15 例采用经肛门技术(5 例开腹手术,10 例腹腔镜手术)的患者均无吻合口并发症,其 ACP 范围在 145 至 300 mBar 之间。所有患者在中位 10 天后均通过自然途径顺利排出 C-REX 吻合环。17 例患者的软性内镜检查显示吻合口愈合良好,无狭窄,1 例患者有中度亚临床狭窄。
这些结果表明,新型经肛门 C-REX 器械是一种可行且有效的方法,可用于开腹和腹腔镜高位前切除术后的结直肠吻合,无论采用哪种方法。此外,C-REX 可测量术中 ACP,从而对吻合口完整性进行定量评估。