Valsamidis Thomas Nikolas, Tøttrup Anders, Ljungmann Ken, Avlund Tue Højslev, Harsløf Sanne, Buchard Charlotte, Iversen Lene Hjerrild
Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Int J Colorectal Dis. 2025 Apr 5;40(1):87. doi: 10.1007/s00384-025-04881-2.
Anastomotic leakage following rectal cancer resection is a serious complication. Despite efforts to prevent it, the risk remains high. Obsidian®ASG, an AUTOLOGOUS fibrin matrix with thrombocytes derived from the patient's blood, shows promise but has not been thoroughly tested in rectal anastomosis. The aim of this study was to assess the feasibility of using Obsidian®ASG as a supplement in rectal anastomosis creation during minimally invasive rectal cancer resection.
This prospective IDEAL stage 2a development cohort study included 50 patients undergoing rectal cancer resection with anastomosis using minimally invasive surgery at Aarhus University Hospital, Denmark. Obsidian®ASG application was assessed using a predefined rating scale: "Complete" (applied in all three prescribed steps), "Almost complete" (applied in at least the first or second step), and "Incomplete" (all others). Feasibility required "Complete" or "Almost complete" application in at least 90% of patients.
Obsidian®ASG application was "Complete" in 15 cases (30%) and "Almost complete" in 35 cases (70%), meeting feasibility criteria in all patients. No "Incomplete" applications occurred. Difficulties in achieving "Complete" application included anatomical constraints, material depletion, machine error, and time constraints.
Obsidian®ASG was successfully applied in all patients undergoing minimally invasive rectal cancer surgery. These findings suggest its feasibility, but further large-scale, multi-center randomized trials are needed to fully assess its potential benefits for patient outcomes.
直肠癌切除术后吻合口漏是一种严重的并发症。尽管已努力预防，但风险仍然很高。Obsidian®ASG是一种源自患者血液的含血小板的自体纤维蛋白基质，显示出一定前景，但尚未在直肠吻合术中进行全面测试。本研究的目的是评估在微创直肠癌切除术中使用Obsidian®ASG作为直肠吻合术辅助材料的可行性。
这项前瞻性IDEAL 2a期开发队列研究纳入了丹麦奥胡斯大学医院50例接受直肠癌切除并采用微创手术进行吻合的患者。使用预定义的评分量表评估Obsidian®ASG的应用情况：“完整”（按规定的三个步骤全部应用）、“几乎完整”（至少应用第一步或第二步）和“不完整”（其他所有情况）。可行性要求至少90%的患者应用“完整”或“几乎完整”。
Obsidian®ASG应用情况为“完整”的有15例（30%），“几乎完整”的有35例（70%），所有患者均符合可行性标准。未出现“不完整”的应用情况。实现“完整”应用的困难包括解剖学限制、材料耗尽、机器故障和时间限制。
Obsidian®ASG在所有接受微创直肠癌手术的患者中均成功应用。这些发现表明了其可行性，但需要进一步开展大规模、多中心随机试验来全面评估其对患者预后的潜在益处。
