Suture reinforcement using a modified cyanoacrylate glue prevents anastomotic leak in colorectal surgery: A prospective multicentre randomised trial.

Abstract Introduction Anastomotic leakage (AL) is the most frequent life-threating complication following colorectal surgery. Several attempts have been made to prevent AL. This prospective, randomised, multicentre trial aimed to evaluate the role of nebulised modified cyanoacrylate in preventing AL after rectal surgery Methods 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 nebulization of 1 cc of a modified cyanoacrylate glue. Preoperative features and intraoperative and post-operative results were recorded and compared. The study was registered at ClinicalTrials.gov (ID number: NCT03941938). Results 133 out of 152 patients (control group, n = 72; cyanoacrylate group, n = 61) completed the follow-up. Clavien–Dindo complications grade >2 were significantly higher in the control group (12.5% vs. 3.3%, p=0.04). 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). No adverse effects were reported. Conclusion Use of modified Cyanoacrylate application to seal colorectal anastomoses is safe and could help to reduce severe post-operative complications; however, its role in the AL prevention remains unclear.