Department of Surgery B, Tel Aviv Sourasky Medical Center, 6 Weizman Street, Tel Aviv, Israel, 64239.
Int J Colorectal Dis. 2010 Dec;25(12):1453-8. doi: 10.1007/s00384-010-0985-7. Epub 2010 Jun 17.
Shape-memory compression bowel anastomosis using a nickel and titanium alloy may reduce leak rates and eliminate foreign anastomotic material. Its safety and efficacy had been demonstrated by animal studies. We conducted the first prospective multi-center clinical evaluation of the safety and effectiveness of BioDynamix anastomosis with ColonRing™ for large-bowel end-to-end or side-to-end anastomosis.
The ColonRing™ was compared to the standard double-stapled colorectal/colocolonic anastomosis. Intraoperative and immediate postoperative and 1- and 3-month postoperative follow-up data were recorded.
Ten study patients (four males, median age 62 years, range 35-75) were compared to 13 demographically matched controls (six males, median age 62 years, range 47-82). Colorectal neoplasia was the most frequent indication for surgery (21/23 patients, 91%). The median anastomotic distance from the anal verge for both groups was 10 cm (6-20 cm). The first postoperative bowel movement was on day 5 ±2.2 (study group) and on day 4 ±1.8 (controls), and the median hospital stay was 8 days (6-14 days) and 7 days (6-13 days), respectively. There were no anastomotic leaks. There were three minor complications in each group, unrelated to the device in the study group. Two patients required transanal digital extraction of the ring which was detached but not expelled (one had a soft anastomotic stricture).
Our preliminary results in this first study on humans indicate that the safety and efficacy of BioDynamix anastomosis with ColonRing™ in colorectal anastomosis in human is comparable to standard staples technology and warrant larger studies for further validation.
使用镍钛合金的形状记忆压缩式肠吻合术可降低漏率并消除外来吻合材料。动物研究已经证实了其安全性和有效性。我们进行了首次前瞻性多中心临床评估，以评估 BioDynamix 吻合术与 ColonRing™ 用于大肠端端或端侧吻合的安全性和有效性。
将 ColonRing™ 与标准双吻合器结直肠/结肠吻合进行比较。记录术中、术后即刻以及 1 个月和 3 个月的术后随访数据。
10 例研究患者（4 例男性，中位年龄 62 岁，范围 35-75 岁）与 13 例匹配的对照组（6 例男性，中位年龄 62 岁，范围 47-82 岁）进行了比较。结直肠肿瘤是最常见的手术指征（23 例中的 21 例，91%）。两组的吻合口距肛缘中位数均为 10 cm（6-20 cm）。研究组的首次术后排便时间为第 5 天±2.2 天，对照组为第 4 天±1.8 天，中位住院时间分别为 8 天（6-14 天）和 7 天（6-13 天）。无吻合口漏。每组各有 3 例轻微并发症，与研究组的器械无关。两名患者需要经肛门数字取出已分离但未排出的环（其中 1 例发生吻合口软化性狭窄）。
我们在人类中的首次研究的初步结果表明，BioDynamix 吻合术与 ColonRing™ 在结直肠吻合中的安全性和有效性与标准吻合钉技术相当，需要进一步验证更大规模的研究。
