General and Visceral Surgery Department, Kepler University Clinic, Linz, Austria.
Department of Applied Systems Research & Statistics, Johannes Kepler University, Linz, Austria.
Surg Technol Int. 2021 Nov 4;39:147-154. doi: 10.52198/21.STI.39.CR11508.
Anastomotic leakage (AL) following colorectal resection is a devastating complication affecting morbidity, mortality, and quality of life of patients in the long term. Different tissue sealants and biologic glues were tested showing conflicting results regarding their influence on anastomotic healing and leak prevention. Application of autologous platelet-rich fibrin (Vivostat A/S, Alleroed, Denmark), which acts as a source of angiogenic growth factors and cytokines, showed promising results in an in-vivo porcine model. Herein, we present the first human study of stapled colorectal anastomoses supplemented with an autologous-derived platelet-rich fibrin matrix (Obsidian ASG®, Rivolution GmbH, Rosenheim, Germany and Vivostat A/S, Alleroed, Denmark).
A retrospective analysis of prospectively accumulated data was performed in two colorectal centers (Linz, Vienna) on patients undergoing left-sided colorectal or coloanal stapled anastomosis between October 2018 and December 2019. The Obsidian ASG® Matrix was applied to the rectal stump, and after closure with the circular stapling device, at the circumference of anastomosis in every single case. Anastomoses were supplemented with intra- and extra-anastomotic application (IAA-intra-anastomotic application developed by Rivolution GmbH, Rosenheim, Germany) of Obsidian ASG® Matrix. The primary endpoints were incidence of perioperative complications and anastomotic leak rate.
Two-hundred-sixty-one (138 female) patients underwent left-sided colonic (n=177) or rectal resection (n=84). In 253 (96.9%) cases, a laparoscopic or robotic-assisted approach was used. There were no complications attributable to the intraoperative application of the Obsidian ASG® Matrix. All intraoperative leak tests were negative. Overall, anastomotic leak rate accounted for 2.3% (6/261). AL following colonic and rectal resection was seen in 2.3% (4/177) and 2.4% (2/84), respectively. Complication and leak rate was similar in the two participating centers. Postoperative fever and elevated CRP levels were significantly correlated to AL. There was no significant risk factor for AL on multivariate analysis.
Application of an autologous-derived platelet-rich fibrin matrix (Obsidian ASG®) at anastomotic site following colorectal resection is safe and associated with a low rate of anastomotic leakage.
结直肠切除术后吻合口漏（AL）是一种严重的并发症，会影响患者的发病率、死亡率和长期生活质量。不同的组织密封剂和生物胶在影响吻合口愈合和预防渗漏方面的效果存在相互矛盾的结果。应用富含血小板纤维蛋白（Vivostat A/S，Alleroed，丹麦）作为血管生成生长因子和细胞因子的来源，在体内猪模型中显示出良好的效果。在此，我们介绍首例应用富含自体血小板纤维蛋白基质（Obsidian ASG®，Rivolution GmbH，Rosenheim，德国和 Vivostat A/S，Alleroed，丹麦）的吻合口吻合的人类研究。
对 2018 年 10 月至 2019 年 12 月在林茨和维也纳的两个结直肠中心接受左侧结直肠或结肠直肠吻合的患者进行前瞻性数据的回顾性分析。Obsidian ASG®基质应用于直肠残端，并用圆形吻合器闭合后，在吻合口的圆周上应用于每个单独的病例。吻合口采用吻合口内（IAA-由 Rivolution GmbH，Rosenheim，德国开发的吻合口内应用）和吻合口外（extra-anastomotic application）应用 Obsidian ASG®基质进行补充。主要终点是围手术期并发症和吻合口漏的发生率。
261 例（138 例女性）患者接受左侧结肠（n=177）或直肠切除术（n=84）。253 例（96.9%）患者采用腹腔镜或机器人辅助方法。术中应用 Obsidian ASG®基质无并发症。所有术中漏诊试验均为阴性。总体而言，吻合口漏的发生率为 2.3%（6/261）。结肠和直肠切除术后吻合口漏分别为 2.3%（4/177）和 2.4%（2/84）。两个参与中心的并发症和漏诊率相似。术后发热和 CRP 水平升高与 AL 显著相关。多因素分析未发现 AL 的显著危险因素。
结直肠切除术后在吻合口部位应用富含自体血小板纤维蛋白基质（Obsidian ASG®）是安全的，吻合口漏的发生率较低。
