Suture reinforcement using a modified cyanoacrylate glue to prevent anastomotic leak in colorectal surgery: a prospective multicentre randomized trial : The Rectal Anastomotic seaL (ReAL) trial.
G Tomasicchio, G Martines, N Tartaglia, M Buonfantino, E Restini, B Carlucci, C Giove, A Dezi, C Ranieri, G Logrieco, L Vincenti, A Ambrosi, D F Altomare, M De Fazio, A Picciariello
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Abstract
Background: 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.
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 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).
Results: 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.
Conclusion: 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.
期刊介绍：
Techniques in Coloproctology is an international journal fully devoted to diagnostic and operative procedures carried out in the management of colorectal diseases. Imaging, clinical physiology, laparoscopy, open abdominal surgery and proctoperineology are the main topics covered by the journal. Reviews, original articles, technical notes and short communications with many detailed illustrations render this publication indispensable for coloproctologists and related specialists. Both surgeons and gastroenterologists are represented on the distinguished Editorial Board, together with pathologists, radiologists and basic scientists from all over the world. The journal is strongly recommended to those who wish to be updated on recent developments in the field, and improve the standards of their work.
Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1965 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted. Reports of animal experiments must state that the Principles of Laboratory Animal Care (NIH publication no. 86-23 revised 1985) were followed as were applicable national laws (e.g. the current version of the German Law on the Protection of Animals). The Editor-in-Chief reserves the right to reject manuscripts that do not comply with the above-mentioned requirements. Authors will be held responsible for false statements or for failure to fulfill such requirements.
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