Massimo Buonfantino
Chirurgia Generale e Oncologica Laparoscopica | Primario di Chirurgia presso Ospedale Civile San Paolo
19 aprile 2024
Main Abstract
Rectal Cancer
ESCP24-ABS-2079
SUTURE REINFORCEMENT USING A MODIFIED CYANOACRYLATE GLUE PREVENTS ANASTOMOTIC LEAK IN COLORECTAL SURGERY: A PROSPECTIVE MULTICENTRE RANDOMISED TRIAL. REAL TRIAL (RECTAL ANASTOMOSIC SEAL)
Giovanni Tomasicchio* 1, Gennaro Martines 2, Nicola Tartaglia3, Enrico Restini 4, Massimo Buonfantino5, Barbara Carlucci 6, Chiara Ranieri6, Carlo Giove 6, Agnese Dezi 6, Gaetano Logrieco 7, Antonio Ambrosi 3, Michele De Fazio6, 8, Arcangelo Picciariello 9.
1PhD candidate in Organs and Tissues Transplantation and Cellular Therapies, DiMePRe-J., University of Bari Aldo Moro, 2 Azienda Ospedaliero Universitaria Policlinico, Bari, 3Department of Medical and Surgical Sciences, DSMC.
University of Foggia, Foggia, 4Hospital “L. Bonomo”, Andria , 5Hospital “San Paolo”, 6DiMePRe-J, University of Bari Aldo Moro, Bari, 7Hospital "F. Miulli", Acquaviva delle Fonti, 8 Centro Interdipartimentale sulle disfunzioni del Pavimento Pelvico, University of Bari Aldo Moro, Bari, 9Department of Experimental Medicine, University of Salento, Lecce, Italy.
Aim: 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.
Method: 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.
Disclosure of Interest: None Declared