Department of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), General Surgery Unit "M. Rubino", University of Bari Aldo Moro, Bari, Italy.
Azienda Ospedaliero Universitaria Policlinico, University of Bari, Piazza G Cesare, 11, 70124, Bari, Italy.
Tech Coloproctol. 2024 Aug 5;28(1):95. doi: 10.1007/s10151-024-02967-7.
Anastomotic leakage (AL) is the most frequent life-threating complication following colorectal surgery. Several attempts have been made to prevent AL. This prospective, randomized, multicentre trial aimed to evaluate the safety and efficacy of nebulised modified cyanoacrylate in preventing AL after rectal surgery.
Patients submitted to colorectal surgery for carcinoma of the high-medium rectum across five high-volume centres between June 2021 and January 2023 entered the study and were randomized into group A (anastomotic reinforcement with cyanoacrylate) and group B (no reinforcement) and followed up for 30 days. Anastomotic reinforcement was performed via nebulisation of 1 mL of a modified cyanoacrylate glue. Preoperative features and intraoperative and postoperative results were recorded and compared. The study was registered at ClinicalTrials.gov (ID number NCT03941938).
Out of 152 patients, 133 (control group, n = 72; cyanoacrylate group, n = 61) completed the follow-up. ALs were detected in nine patients (12.5%) in the control group (four grade B and five grade C) and in four patients (6.6%), in the cyanoacrylate group (three grade B and one grade C); however, despite this trend, the differences were not statistically significant (p = 0.36). However, Clavien-Dindo complications grade > 2 were significantly higher in the control group (12.5% vs. 3.3%, p = 0.04). No adverse effects related to the glue application were reported.
The role of modified cyanoacrylate application in AL prevention remains unclear. However its use to seal colorectal anastomoses is safe and could help to reduce severe postoperative complications.
吻合口漏（AL）是结直肠手术后最常见的危及生命的并发症。已经有几种尝试来预防 AL。本前瞻性、随机、多中心试验旨在评估雾化改性氰基丙烯酸酯在预防直肠手术后 AL 中的安全性和有效性。
2021 年 6 月至 2023 年 1 月期间，五个高容量中心的中高位直肠癌患者接受结直肠手术，并进入研究，随机分为 A 组（吻合口用氰基丙烯酸酯加固）和 B 组（不加固），并随访 30 天。吻合口加固通过雾化 1ml 改性氰基丙烯酸胶来进行。记录并比较术前特征、术中及术后结果。该研究在 ClinicalTrials.gov 注册（编号 NCT03941938）。
在 152 名患者中，133 名（对照组 n=72；氰基丙烯酸酯组 n=61）完成了随访。对照组 9 名（4 级 B 级和 5 级 C 级）和氰基丙烯酸酯组 4 名（3 级 B 级和 1 级 C 级）患者发生 AL，但差异无统计学意义（p=0.36）。然而，尽管有这种趋势，对照组的 Clavien-Dindo 并发症分级>2 显著更高（12.5% vs. 3.3%，p=0.04）。未报告与胶应用相关的不良反应。
改性氰基丙烯酸酯在预防 AL 中的作用尚不清楚。然而，其用于密封结直肠吻合口是安全的，并可能有助于减少严重的术后并发症。
