The Journal of surgical research · 2025
Results of a New Patch to Externally Reinforce Colorectal Anastomosis: An Experimental Study.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Škrabec Clara Gené, Pérez Manel Cremades, Gatell Laia, Weis Christine, Izco Jesús M, Rodriguez Rivero Anna Maria, Zuñiga Teresa, Parés David, Julián Ibáñez Joan Francesc
Аннотация
INTRODUCTION: Anastomotic leak (AL) is a serious complication in colorectal surgery, associated with increased morbidity, mortality, and healthcare costs. Technological advances have yet to eliminate AL, which occurs from 5% to 14% of cases involving anastomosis. This study introduces and evaluates a new collagen-cyanoacrylate patch designed to externally reinforce colonic anastomoses with the aim to contain anastomotic leaks. The objective of the study is to evaluate the feasibility and safety of a novel collagen-cyanoacrylate patch to reinforce colonic anastomosis in a porcine model.
METHODS: A preclinical study adhering to Good Laboratory Practices was conducted on 12 Landrace x Large White pigs. Following a previously validated model for a deficient anastomosis, a 21-mm defect was created at a colorectal anastomosis to simulate an AL. Pigs were randomized to receive either reinforcement with the collagen-cyanoacrylate patch or no reinforcement. Safety and feasibility were assessed, analyzing the integration of the patch in colorectal structures. In addition, as secondary outcomes, we assessed clinical monitoring, behavioral observations, blood tests for inflammatory markers, and histopathological analysis.
RESULTS: The collagen-cyanoacrylate patch was easily applied, adhered effectively to the bowel surface, successfully sealed the defect, and was naturally degraded during the healing process. No significant differences in stenosis or adhesions were observed between the experimental and control groups, although minor variations in inflammatory and infectious markers were noted. All animals exhibited a 100% survival rate, and no clinical signs of AL were observed.
CONCLUSIONS: The use of collagen-cyanoacrylate patch is feasible, safe, and has good clinical outcomes, showing promise in preventing colonic AL. Further studies using an adequate anastomotic leak model or clinical studies are needed to confirm efficacy.
METHODS: A preclinical study adhering to Good Laboratory Practices was conducted on 12 Landrace x Large White pigs. Following a previously validated model for a deficient anastomosis, a 21-mm defect was created at a colorectal anastomosis to simulate an AL. Pigs were randomized to receive either reinforcement with the collagen-cyanoacrylate patch or no reinforcement. Safety and feasibility were assessed, analyzing the integration of the patch in colorectal structures. In addition, as secondary outcomes, we assessed clinical monitoring, behavioral observations, blood tests for inflammatory markers, and histopathological analysis.
RESULTS: The collagen-cyanoacrylate patch was easily applied, adhered effectively to the bowel surface, successfully sealed the defect, and was naturally degraded during the healing process. No significant differences in stenosis or adhesions were observed between the experimental and control groups, although minor variations in inflammatory and infectious markers were noted. All animals exhibited a 100% survival rate, and no clinical signs of AL were observed.
CONCLUSIONS: The use of collagen-cyanoacrylate patch is feasible, safe, and has good clinical outcomes, showing promise in preventing colonic AL. Further studies using an adequate anastomotic leak model or clinical studies are needed to confirm efficacy.