Department of General, Visceral and Transplant Surgery, Tübingen University Hospital, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
General and Visceral Surgery, Maria Hilf Hospital, Viersener Str. 450, 41063, Mönchengladbach, Germany.
Surg Endosc. 2022 Dec;36(12):8881-8892. doi: 10.1007/s00464-022-09323-6. Epub 2022 May 23.
Reported incidence of anastomotic leakage (AL) of rectal anastomoses is up to 29% with an overall mortality up to 12%. Nevertheless, there is no uniform evidence-based diagnostic procedure for early detection of AL. The objective of this prospective clinical trial was to demonstrate the diagnostic value of early postoperative flexible endoscopy for rectal anastomosis evaluation.
Flexible endoscopy between 5 and 8th postoperative day was performed consecutively in 90 asymptomatic patients. Sample size calculation was made using the two-stage Simon design. Diagnostic value was measured by management change after endoscopic evaluation. Anastomoses were categorized according to a new classification. Study is registered in German Clinical Trials Register (DRKS00019217).
Of the 90 anastomoses, 59 (65.6%) were unsuspicious. 20 (22.2%) were suspicious with partial fibrin plaques (n = 15), intramural hematoma and/or local blood coagulum (n = 4) and ischemic area in one. 17 of these anastomoses were treated conservatively under monitoring. In three a further endoscopic re-evaluation was performed and as consequence one patient underwent endoscopic vacuum therapy. 11 (12.2%) AL were detected. Here, two could be treated conservatively under monitoring, four with endoscopic vacuum therapy and five needed revision surgery. No intervention-related adverse events occurred. A change in postoperative management was made in 31 (34.4%) patients what caused a significant improvement of diagnosis of AL (p < 0.001).
Early postoperative endoscopic evaluation of rectal anastomoses is a safe procedure thus allows early detection of AL. Early treatment for suspicious anastomoses or AL could be adapted to avoid severe morbidity and mortality.
直肠吻合口瘘(AL)的报道发生率高达 29%,总死亡率高达 12%。然而,目前尚无用于早期检测 AL 的统一循证诊断程序。本前瞻性临床试验的目的是证明术后早期行灵活内镜检查对直肠吻合口评估的诊断价值。
连续对 90 例无症状患者在术后第 5-8 天行灵活内镜检查。使用两阶段西蒙设计进行样本量计算。通过内镜评估后的管理变更来衡量诊断价值。吻合口根据新分类进行分类。该研究在德国临床试验注册处(DRKS00019217)注册。
90 个吻合口中,59 个(65.6%)无异常。20 个(22.2%)可疑,部分纤维蛋白斑块(n=15)、壁内血肿和/或局部血凝块(n=4)和一处缺血区。这些吻合口中有 17 个在监测下保守治疗。其中 3 个进一步行内镜再评估,因此 1 个患者接受内镜真空治疗。检测到 11 个(12.2%)AL。其中,2 个可在监测下保守治疗,4 个接受内镜真空治疗,5 个需要手术修复。无与干预相关的不良事件发生。31 例(34.4%)患者的术后管理发生变化,这显著提高了 AL 的诊断(p<0.001)。
直肠吻合口术后早期内镜评估是一种安全的方法,可早期发现 AL。对可疑吻合口或 AL 的早期治疗可以进行调整,以避免严重的发病率和死亡率。